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On June 23, 2009, the attorneys at Burg Simpson filed a complaint on behalf of their client, Barbara Bender, against Baxter Healthcare Corporation, Baxter International, Inc., Scientific Protein Laboratories, LLC, and American Capital, Ltd. in the pending heparin products liability litigation.
Continue reading "BURG SIMPSON FILES NEW LAWSUIT REGARDING CONTAMINATED HEPARIN" »
Last week, three patients in a Delaware hospital, each of whom received Heparin, a blood thinner distributed by Baxter International Inc., suffered intra cranial bleeding. Baxter insists that the injuries, while unfortunate, are not related to the quality of its Heparin product.
Continue reading "Heparin Contamination Worries Not Over for Baxter" »
YAZ, a birth control pill manufactured by Bayer Healthcare, often is touted not only as effective in the prevention of pregnancy, but also as effective in the treatment of premenstrual dysphoric disorder (PMMD) and acne. But in October 2008, the FDA deemed Bayer’s advertisement of YAZ, known for its slogan – “Beyond Birth Control”- misleading and in violation of federal regulations.
Continue reading "YAZ - Not All It’s Made Out To Be" »
Nephrogenic Systemic Fibrosis has been identified with exposure to gadolinium-containing contrasting agents used in MRI and patients suffering renal failure and under kidney dialysis. Due to the nature of the disease and its swift and progressive attack that hardens and thickens skin and other tissues throughout the body, the Court has pushed for an aggressive trial schedule since many of the plaintiffs are very ill and may not survive lengthy litigation. The federal gadolinium litigation has been consolidated before Judge Dan Polster in the United States District Court for the Northern District of Ohio for purposes of pretrial litigation. According to Judge Polster, Bayer Healthcare, one of the 5 manufacturers of the gadolinium contrasting agents, has initiated settlement negotiations with a number of plaintiffs. About 400 gadolinium lawsuits have been filed in state or federal courts against Bayer and the makers of four other types of MRI contrast agents, including GE Healthcare’s Omniscan, Bracco Diagnostics’ MultiHance and ProHance, and Mallinckrodt’s OptiMARK. Details of gadolinium settlement negotiations have not been publicly released, during a recent status conference held on March 6, 2009, Judge Polster confirmed that discussions have taken place and suggested that several cases may settle in the near future.
In Copenhagen, Denmark the health minister has promised compensation to kidney patients who contracted Nephrogenic Systemic Fibrosis after being administered Omniscan, a contrast agent used in MRI to enhance tissue images. Here in the states there are also a number of lawsuits against the 5 manufacturers of gadolinium contrasting agents including the makers of Omniscan. NSF is characterized by the progressive hardening of skin and joints and sometimes internal organs that often result in the inability to move about without a wheelchair. Currently there is no treatment for the condition. Attorneys for the victims in the United States have asked for the suits to be prioritized because some of their plaintiffs are in dire circumstances while others have already perished from the debilitating disorder. As for Jakob Axel Nielson, the health minister in Denmark he says,
“The least we can do for these deeply ill people, who unfortunately became more sick after being administered Omniscan, is to identify them and offer compensation.”In an effort to identify any other victims Nielson has asked all the health regions to carry out extensive studies into kidney patients to discover if more qualify for compensation.
Seven lawsuits have been filed on behalf of Tennessee families who were affected by the recalled drug Digitek. Digitek is the trade name for digoxin, which is used to treat heart failure and abnormal heart rhythms. According to the lawsuits, five of the seven Digitek users died as a result of unintentional overdoses due to the oversized tablets. In a manufacturing error Digitek tablets were made double the thickness, thus dispensing double the dosage. When taking an excessive amount of Digitek it can cause nausea, vomiting, low blood pressure, heart attacks, strokes and death.
The prescription pain medication Darvon has been under fire for some time concerning its troubling problems such as addiction and suicide. A government medical advisory panel for the U.S. Food and Drug Administration voted 14 to 12 in recommending the withdrawal of the popular pain killer from consumer use after a day long hearing examining its risks and benefits. In 2005 the United Kingdom banned its version of Darvon for the same reasons. Darvon was first approved in 1957, when there were few alternatives for treating pain except aspirin and powerful narcotics. The non-profit consumer group Public Citizen petitioned the FDA for the removal of Darvon, now mainly marketed as Darvocet which contains acetaminophen, after expressing concern over the drug’s relatively weak pain relief and the potential overdose risk.
“With a drug that has almost no evidence of benefit, any risk is unacceptable,” said Dr. Sidney Wolfe, a drug safety expert with Public Citizen who first sought a ban in the 1970s. “Hopefully the FDA will follow the vote of its advisers.”The two companies that market the drug, Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, say the medication is safe and effective when used as directed. If the FDA elects to not take the panel’s advice, which is unlikely, further measures such as stiffer warnings, safety studies or special education efforts aimed at doctors and patients may be put in place.
In the February issue of Radiology researchers raised awareness of the risk factors between gadolinium based contrast agents and the onset of Nephrogenic Systemic Fibrosis. Javier Perez-Rodriguez, of the Johns Hopkins University School of Medicine in Baltimore, and colleagues describe 33 patients diagnosed with NSF from 2003 to 2008. All the patients had advanced renal failure at the time they were given gadolinium contrasting agents prior to an MRI. The time between exposure to gadolinium and the presentation of NSF was an average of 29 days. Researchers reported before the U.S. Food and Drug Administration issued warnings about the association between gadolinium exposure and NSF, the overall incidence of the disease was 36.5 cases in 100,000 patients. After the FDA pressed for a “black box” warning on the contrasting products the amount of NSF cases dropped to 4 per 100,000 patients.
In conclusion the authors write, “In January 2007, our institution implemented policies regarding the use of GBCA in patients with severe renal dysfunction, with the aim being to reduce the incidence of NSF. These policies were associated with a significant reduction in the incidence of NSF. Besides the previously reported epidemiologic considerations of NSF associations, the success of such a policy in the reduction of NSF due to GBCA exposure strengthens the belief that there is a causal relationship between GBCA and NSF.”
Makers of the bone strengthening osteoporosis drugs such as Fosamax, Actonel and Boniva are facing new challenges to the efficacy of their drugs. The Food and Drug Administration recently reported there is a small risk of contracting esophageal cancer if taking the drugs. Diane K. Wysowski of the FDA's division of drug risk assessment said the agency has received 23 reports of the cancer developing in patients taking Fosamax of which eight of the patients died. European and Japanese authorities have reported an additional 21 cases of cancer. The drugs were already known to cause esophagitis, an inflammation of the lining of the esophagus or throat, which is why patients are told to remain upright for a half-hour after taking the drugs. That inflammation might be a precursor of cancer. Wysowski recommended that physicians not prescribe the drugs to patients who already have problems with their esophagus. The bone strengthening drugs have previously been linked to osteonecrosis (bone
death) of the jaw.
The U.S. Food and Drug Administration recently announced that it now requires a black-box warning to be put on the labeling for two prescription drug products used prior to a colonoscopy. It has been reported to the FDA that the oral sodium phosphate products, Visicol and OsmoPrep have caused kidney injury. “The FDA has received reports of 20 unique cases of kidney injury associated with the use of OsmoPrep,” Dr. Joyce Korvick, deputy director of FDA's Division of Gastroenterology Products at the Center for Drug Evaluation and Research said.
“Of the reported cases, three were biopsy-proven cases of acute phosphate nephropathy. The onset of kidney injury in these cases varied, occurring in some within several hours of use of these products and in other cases up to 21 days after use.” The FDA is also concerned about similar non-prescription treatments, such as Fleet Phospho-soda made by C.B. Fleet Co. and stated they will get new warnings as well.
A leading online source of health information, WebMD is expanding its consumer access by teaming up with the U.S. Food and Drug Administration. Although many online visitors are aware of the FDA website, as many as 50 million use WebMD. “We are enthusiastic about this collaboration with WebMD because it will enable us to reach more consumers with accurate, science-based information that can help them improve their health,” said Andrew C. von Eschenbach, M.D., commissioner of food and drugs. “This is an important step forward in our effort to form partnerships to help bring timely safety alerts and other public health information to a wider audience in the most effective and convenient way.” WebMD visitors will be able to access information of FDA-regulated products such as food, medicine and cosmetics as well as report problems involving the safety of products directly to the FDA. FDA health alerts will also be included in the co llabor ation. “As a leading brand of health information, we are pleased to be partnering with the FDA to provide consumers with public health and safety information, direct from the source,” says Wayne Gattinella, WebMD president and chief executive officer. “This important partnership is consistent with WebMD's longstanding mission of providing for Americans access to credible and relevant health information.” According to a national study released in August 2008 by the Center for Studying Health System Change, researchers found that 32 percent of American consumers, approximately 70 million adults, conducted online health searches in 2007, compared with 16 percent in 2001.
Unfortunately under the next administration, Obama will be forced to deal with the inadequacies of the U.S. Food and Drug Administration. For some time now the FDA has been struggling to protect Americans from unsafe medication, defective medical devices, contaminated food and numerous questionable imports from China and other countries. The FDA has been operating with a small budget, antiquated technology and inadequate leadership and personnel according to members of Congress, watchdog groups and various government reports. "Everywhere you go, you hear the same chorus: The agency's in trouble," said David A. Kessler, who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton. "There's a general perc eption the agency is suffering mightily." The FDA’s credibility is under scrutiny as they are being accused of allying themselves with the pharmaceutical industry rather than consumer safety. It didn’t help when several issues arose out of China alone including tainted human and pet food, contaminated toothpaste, tainted heparin that took the lives of at least 81 Americans and caused hundreds of serious illnesses. The E. coli and Salmonella infected produce prompted large scale recalls nationwide. "I'm afraid we're going to see more horrible things happen if we don't get our act together on this," said David Ross, who was a drug reviewer at the agency for 10 years. Regardless of their credibility, the agency is suffering falling morale as it tries to keep up with its responsibilities while under fire from the outside. "FDA is close to being at a tipping point -- the agency is hanging on by its finge rtips in protecting us," said William K. Hubbard, who worked for the agency for 27 years. "If something is not done, they could become a failed institution, and no one wants that. The FDA is not only important to protecting the public health but also to the industries it regulates."
Victims of the debilitating condition Nephrogenic Systemic Fibrosis will have to wait an additional 90 days in seeking retribution. NSF is a progressive disorder characterized by the hardening and thickening of skin that severely restricts movement and in many cases leads to immobility. The U.S. District Judge Dan Polster who is overseeing the lawsuits in the U.S. District Court for the Northern District of Ohio postponed the litigation to give more time in the bellwether selection of 10 cases as a result of the number of gadolinium contrasting agents responsible for the disorder. Approximately 300 lawsuits have been filed against the manufacturers of the five different types of gadolinium based contrast agents identified as responsible for NSF by multiple researchers and medical doctors. Lawyers representing individuals who have filed NSF lawsuits have been pushing for an aggressive t rial s chedule, as many of the plaintiffs are very sick and may not survive lengthy litigation. It is likely that the first NSF lawsuits will not reach a jury until Fall 2009.
In an effort to warn consumers of the side effects of the osetoporosis drugs used to limit bone loss, Susan Lark, MD a medical researcher and women’s health practitioner issued a statement determined to highlight concerns. “Without a doubt, the newest osteoporosis drug on the market, Reclast, is not the miracle drug its marketers want you to believe it is. While this once-yearly IV treatment is touted as safe and convenient, its side effects far outweigh its benefits,” says Dr. Lark. “In fact, all bisphosphonates should be avoided because they can cause gastrointestinal side effects, chemical burning of the esophagus, infection and death of bone tissue in the jaw (called osteonecrosis), and kidney toxicity. And Reclast, in particular, has been shown to cause heart rhythm abnormalities like atrial fibrillation. These side effects are dangerous and hardly seem worth it, especially when there are extremely safe, natural ways to prev ent an d treat bone loss.” Further, according to Dr. Lark the drugs don’t stimulate new bone growth, but instead slow the rate of loss of old bone. Ultimately, this means the bone building capabilities in the bones of women taking bisphosphonates are in fact over-aged, damaged bone cells that have not sloughed off as they should. The drugs she spoke out against include Boniva, Actonel, Fosamax and Reclast.
In an effort to notify doctors of the risks of acquiring nephrogenic systemic fibrosis following an MRI in patients with insufficient kidney function, UroToday published an article encouraging physicians to take notice. Nephrogenic systemic fibrosis develops following exposure to MRI imaging products containing gadolinium. Its long term effects devastate the patient leaving them wheelchair bound and can sometimes lead to death. A recent study linked the contrasting agent to the disorder. The symptoms of NSF usually develop within weeks to months after exposure to gadolinium. The study also revealed algorithms to follow when determining the safety in the use of gadolinium, indicating that those with severe renal impairment are not to be exposed to any level of the agent. They conceded that further research needs to be directed in finding agents that will stabilize gadolinium and make MRI imaging safe for all patients.
Five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized by U.S. Marshals at the FDA's request in an ongoing effort to ensure patients remain safe. The contaminated Heparin was removed from Celsus Laboratories Inc. in Cincinnati, Ohio. “This action will help prevent this contaminated heparin from finding its way into the marketplace,” said Mike Chappell, acting associate commissioner for regulatory affairs, FDA. The over-sulfated chondroitin sulfate (OSCS) contamination, a substance that mimics heparin's anticoagulant activity, has been linked to multiple adverse events and deaths since January 2008. To date, the FDA has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies. The FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company's actions to notify customers about a contaminant in its Heparin were insufficient to assure an effective recall.
The ETHEX Corporation is further expanding its drug recall initiated in late October. At that time ETHEX had voluntarily recalled 3 lots of their Dextroamphetamine Sufate 5 mg tablets due to oversized tablets made in the manufacturing process. They are now expanding the recall to include 5 further lots of generic products including:
Continue reading "ETHEX Corporation Expands Drug Recall " »
The U.S. Food and Drug Administration has issued a warning letter to Sun Pharma’s U.S. based subsidiary Caraco in Detriot, Michigan for certain manufacturing deficiencies. The letter was issued as a follow up to the last FDA inspection of the company's manufacturing facility in Detroit initiated in May 2008. This latest suspension is on the heals of a ban imposed on 30 drugs manufactured by another pharmaceutical company, Ranbaxy in India. The FDA is directing Caraco to report what measures it will take to resolve the deficiencies. Until such a time, the FDA has suspended the approval of any drug applications until the issue is resolved. There are 96 abbreviated new drug applications (ANDAs) filed by Sun Pharma awaiting approval, of which 19 have been filed by Caraco. “The FDA has not banned the sale of Sun Pharma drugs in the US, and there was no recall of medicines by the company in the US market,” a company official stated. Sun Pharma and Caraco collaboratively market about 60 products in US. In response, company officials believe, “Any adverse happening in India and China always gets magnified adverse publicity.” Well, when hundreds of thousands of people are put at risk from lack of quality control measures, it tends to worry them. In addition to Ranbaxy, pharmaceutical companies Wockhardt and Granules India received similar warning letters from the US FDA in the past for defects at their facilities.
Even as Johnson & Johnson has paid out at least $68.7 million in out-of-court settlements over side effects of the birth control patch Ortho Evra, they still maintain it is a safe alternative for birth control. Over twenty women have died and in excess of 4,000 have filed complaints in state and federal courts claiming Ortho Evra was responsible for and caused deep-vein thrombosis-blood clots in the legs and pulmonary embolisms-blood clots in the lungs. As of mid-October Johnson & Johnson has not released financial records of the settlements to its investors. Gloria Vanderham, a spokesman for Ortho-McNeil Pharmaceutical, Inc., that manufactures the drug for Johnson & Johnson, told Bloomberg.com, “Ortho Evra provides a needed birth-control option for women and physicians. When used according to the FDA- approved label, Ortho Evra is a safe and effective method of hormonal birth control.” However, in 2005, after investigations by the US Food & Drug Administration, the company was told to update its product label to say that Ortho Evra exposes women to 60 percent more estrogen than the typical birth-control pill and that higher estrogen increases side effects. In 2006, a federal drug safety report “indicate that in 2004 when 800,000 women were on the patch the risk of dying or suffering a survivable blood clot while using the device was about three times higher than while using birth control pills.” It is still touted as a safe alternative by the drug company.
The U.S. Food and Drug Administration has posted new information on its site about medications with troubling safety profiles. This was a part of Congress’s mandate to the FDA last year in an attempt to limit medication related adverse events. The list is not to alarm patients, but to empower them with knowledge they can go to their doctor with and seek advice. It is in no way intended to prevent patients from taking the medication their doctor has prescribed. The medications were identified between January and March 2008. Some of the medications listed include: Cymbalta, Heparin and Nitroglycerin. The drugs listed have varying degrees of risk. Cymbalta can cause urinary retention, Heparin can cause allergic reactions, and Nitroglycerin has potential overdosing issues due to labeling confusion. Oxycontin and Dilantin are two on the list of particular interest for headache sufferers. The FDA’s list will be updated quarterly and currently includes 20 different medications. Many of the medications on the list have been a concern for quite a while.
The non-profit consumer group Public Citizen has petitioned the U.S. Food and Drug Administration to pull the Type 2 diabetes drug Avandia off the market. Over the last two years concerns have arisen about the life-threatening risks associated with the drug including heart and liver damage. Starting in the spring of 2007 the drug had been denounced by a number of medical groups. Last week, the American Diabetes Association and a European counterpart jointly released updated treatment guidelines for doctors that clearly recommended against the use of Avandia. In a medical journal two years ago an article noted a 43 percent higher risk of heart attacks among patients taking Avandia in comparison of those taking other diabetes drugs. “The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities,” Public Citizen said in its petition. “Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure.” In response the FDA said it will “carefully review” the petition and will continue to monitor Avandia’s safety record. Although scientists are still debating the link between Avandia and an increase risk of a heart attack, concerns about the medical evidence led to stronger warnings. As a result of the stronger warnings, Avandia use dropped sharply. Public Citizen produced its own evidence finding 14 cases of liver failure of which 12 led to death. Makers of Avandia, GlaxoSmithKline, in a statement, said it does not believe the drug causes liver failure. The company said its own data shows the drug has a good safety record when it comes to liver problems, but said the data on heart attacks is inconclusive and that Avandia is safe and effective.
In an effort to protect young women from HPV (human papalloma virus) the vaccine Gardisil was created to guard against the virus linked to cervical cancer in women. However, the National Vaccine Information Center is concerned of the side effects experienced by the young women who elect to be vaccinated against HPV. In 2006, the NVIC questioned the efficacy of Merck’s pre-license Gardisil vaccine safety data for girls under age 16. In 2007 they made three reports analyzing serious adverse events experienced and reported to the federal Vaccine Adverse Event Reporting System (VAERS). In 2008 about 20 percent of all vaccine adverse event reports to VAERS were related to Gardisil. Such adverse events include some experiencing paralysis and 27 deaths that have been reported as a result of the vaccine. However, the Centers for Disease Control and the U.S. Food and Drug Administration are alleging that the 9,000 HPV vaccine adverse events are not related to the Gardisil vaccine based on an internal analysis. Now the VAERS are calling on the CDC and the FDA to publicly release the argumentative data showing Gardisil is safe with no serious side effects. “Transparency in government is essential to trust in government and replication is the hallmark of good science,” said NVIC co-founder and president Barbara Loe Fisher. “Parents of young girls and women cut down in their prime - some of them paralyzed or dead within hours or days of getting Gardasil vaccine - deserve better answers than a whitewashing of this vaccine's very serious side effects. Until there is an independent confirmation of these unverified findings by individuals and companies without financial ties to the government or industry, it is not credible.” NVIC was founded in 1982 and worked with Congress on the 1986 National Childhood Vaccine Injury Act. The non-profit watchdog group advocates for safer vaccine policies and the legal right for Americans to make informed, voluntary decisions about vaccination. http://www.nvic.org
In a recent Bloomberg Health News article the company speculated that pharmaceutical company Johnson & Johnson has spent as much as $68.7 million in settlements over its birth control patch Ortho Evra. While that amount may be staggering to some, the settlements prevent the victims or their families and their lawyers to speak about it. Without foreknowledge of a products possible danger how can future potential victims make an informed choice? The settlements included 20 young women who died as a direct result of the patch and a staggering 1,330 victims are part of a class-action lawsuit currently being litigated in Ohio. As many as 4,000 complaints have been filed concerning the controversial patch and yet Johnson & Johnson refuses to pull it from pharmacy shelves. The consumer advocacy group Public Citizen has gone so far as to ask the U.S. Food and Drug Administration to recall the birth control patch. By every indication the manufacturer J&J certainly has no plans to safeguard women’s lives and voluntarily recall it themselves. The decision to continue to sell it indicates that the company may not have their consumers’ best interest at heart and that money is the driving factor, not responsible pharmaceutical treatment.
On October 21, 2008 lawyers met with the Court to discuss the process for selecting the first Nephrogenic Systemic Fibrosis lawsuits for trial and which of the five gadolinium contrast agents the plaintiffs’ were exposed to during MRIs. The use of gadolinium based contrast agents used in MRIs has been linked to NSF in patients with moderate to severe kidney dysfunction. As of now almost 400 NSF lawsuits have been filed against the 5 manufacturers of the contrasting dye. In an effort to centralize and coordinate pretrial litigation the U.S. Judicial Panel of Multidistrict Litigation transferred all the NSF federal cases to Judge Dan Polster in the U.S. District Court for the Northern District of Ohio in February 2008. Judge Polster has been assigned to nearly 300 of the lawsuits. Lawyers representing the individuals and families whose lives have been affected by NSF are pushing the court to begin trial quickly because many of their clients are sick and may not survive a lengthy litigation.
In the first three months of 2008 the number of serious drug reactions and deaths reported to the U.S. Food and Drug Administration set a new record high according to the health industry watchdog group the Institute for Safe Medication Practices (ISMP). The FDA received 20,745 reports of serious drug reactions between January and March 2008 which is 38 percent higher than average and is the highest for any quarter reported. The 4,824 deaths between the three months was nearly a threefold increase. The two drugs at the center of the reports and are responsible for the most reactions were the blood thinner heparin imported from China and Chantix an anti-smoking drug from Pfizer. Chantix is at the top of the list for serious drug reactions. Earlier this year the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. The ISMP study found that heparin accounted for 779 reports of serious drug reactions, including 102 deaths with a possible 238 deaths associated to the tainted heparin. “The FDA is aware of the increasing number of reports, and we take them seriously,” said spokesman Christopher DiFrancesco. Previous ISMP research has shown that reports of serious drug safety problems had increased markedly since the late 1990s. This seems to be an alarming trend in today’s drug market. The FDA must be overwhelmed by the increased reports of serious drug side effects which could offer the drug companies an opportunity to push through possibly dangerous drugs because of the FDA’s increased workload.
The consumer advocacy and nonprofit group Public Citizen has petitioned the FDA to phase out sales of the Ortho Evra Birth Control patch over a six-month period. “Ortho-Evra is a poor choice for women,” wrote Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. Johnson & Johnson released the alternative form of birth control in 2001 marketing it in such a way that it would be preferable to the birth control pill because it provides lower and more stable estrogen levels and would be easier for women to use. Studies since then have shown otherwise, J&J’s claims have proven false. Even with stricter “black box” warnings on the packaging, Public Citizen says that the serious risks outweigh any benefit of the use of the patch. J&J’s compliance to the stepped up warnings are not enough to protect young women electing birth control. “Had Ortho-Evra been designed as a pill, it is unlikely to have been approved because of its increased estrogen content,” Wolfe said. The patch exposes women to up to 60 percent more estrogen than the pill. Studies suggest that women using Ortho-Evra have twice the risk of blood clots as women taking the pill, and are also at increased risk for other side effects such as breast discomfort, nausea, vomiting and severe menstrual pain. The FDA has updated the drug's label with warnings about blood clots three times since 2005.
As part of the Food and Drug Administration Amendments Act of 2007, the FDA has developed a website catering to consumers and professionals questions about prescription drug information. The website offers links to such areas as drug labeling, risk evaluation, clinical trials and drug-specific safety information. The site also provides links to quarterly listings of drugs that are being evaluated for safety issues, FDA warning letters, import alerts, recalls, market withdrawals and safety alerts and consumer articles on drug safety. “By placing Web links to these up-to-date resources on a single page, we're helping consumers and healthcare professionals find drug safety information faster and easier,” said Dr. Paul Seligman, the FDA's associate director of safety policy and communication. “This type of communication is aimed at helping consumers and healthcare professionals make well-informed decisions about medication use.” The website is available at //www.fda.gov/cder/drugSafety.htm.
In a frightening “déjà vu” moment another company has had to recall their drug because of an increased size of the tablets containing up to twice the labeled amount of the active ingredient. The U.S. Food and Drug Administration is warning that the ETHEX Corp. announced a voluntary recall of 3 lots of their Dextroamphetamine Sufate 5 mg tablets. The risks associated with an over dosage of the drug are tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset and dry mouth may be increased. The recalled lots were distributed between January 2007 and may 2008. The 5 mg product is an orange round tablet with "ETHEX" and "311" on one side. Any adverse reactions experienced with the use of this product should be reported to the FDA immediately.
A new study undergone by researchers at Vanderbilt University has again shown a strong link between the use of gadolinium dyes and the disease Nephrogenic Systemic Fibrosis found in patients with renal failure. The team of researchers concluded with the warning that gadolinium contrast dyes should be used “judiciously” in patients with kidney disease opining that the benefits should be carefully weighed against the risks. In the study researchers at Vanderbilt analyzed data from case reports submitted to the U.S. Food and Drug Administration. The study found the occurrence of NSF after gadolinium contrast agent exposure depended on the degree of renal dysfunction, amount of contrast agent administered, gadolinium contrast agent stability and the severity of a patient’s kidney disease. NSF has devastated the lives of hundreds of individuals and their families. NSF is characterized by high blood pressure, burning, itching, swelling and hardening of the skin to the point of immobility. Other symptoms include deep pain in the hips and ribs and muscle weakness. In September 2007 the FDA ordered a “black box” warning, the most severe used, to be added to the labels of the manufacturers products including, Bayer HealthCare Pharmaceuticals, Bracco Diagnostics, GE Healthcare and Mallinckrodt. Since then lawsuits have been filed in state and federal courts against the companies for the injuries incurred after the exposure to the gadolinium contrast dyes. As of September 24, there were 287 NSF lawsuits pending in the Multidistrict Litigation. Another 104 lawsuits have been filed in various state courts throughout the U.S.
A Congressional Committee recently said they are investigating the U.S. Food and Drug Administration’s handling of a drug recall at Actavis Totowa LLC’s facility in New Jersey. The Iceland based drug maker in early August recalled 66 drugs made at the New Jersey plant. Prior to this recent recall, the company recalled its heart drug Digitek because in the manufacturing process the pills were made double thickness and caused numerous side effects across the country. The House Energy and Commerce Committee said the numerous recalls from Actavis' New Jersey plant raise questions about the FDA's oversight of drug facilities. “Recalls of this seriousness cause us to question whether FDA was deceived...or did FDA simply fail to conduct adequate and timely inspections of these facilities,” Reps. John Dingell and Bart Stupak, Democrats from Michigan, said in a letter to FDA Commissioner Andrew von Eschenbach. The Representatives said they want to know whether the FDA permitted additional products from Actavis on the market while it knew about problems at the company's plants. The committee’s investigation comes on the heals and is triggered partially by the import ban of more than 30 drugs from the India owned Ranbaxy Laboratories Ltd., one of the world’s largest generic drug manufacturers. Ranbaxy has also been facing investigations by the U.S. Department of Justice and the FDA into whether it made substandard generic drugs. Allegations include that Ranbaxy fabricated evidence to support drug applications and attempted to conceal violations of manufacturing practices.
According to a Bloomberg Health New report Johnson & Johnson has spent at least $68.7 million to settle hundreds of lawsuits filed by women who suffered blood clots, heart attacks or strokes after using the company’s Ortho Evra birth control patch. J&J has avoided trials through the confidential settlements and court papers do not indicate how much the pharmaceutical company has paid in each case.. Bloomberg reviewed 562 complaints alleging the patch caused deep-vein thrombosis - blood clots in the legs and pulmonary embolisms – blood clots in the lungs. The complaints also blame Ortho Evra for the deaths of 20 women, Bloomberg wrote. Complaints filed on behalf of 4,000 women in state and federal courts claim the company hid or altered data about the risks of high levels of estrogen released by Ortho Evra. Janet Abaray, an attorney for the plaintiffs, is helping lead the litigation before U.S. District Judge David Katz in Toledo, Ohio where 1,330 patch cases have been combined into a class-action suit. Abaray said in an April 17 court document that, “Several hundred individual cases” had been settled by March 31 and “there have been a significant number that have settled since then.” Attorneys requesting anonymity and who are familiar with the litigation told Bloomberg that J&J typically settles the death cases for more than $1M, deep-vein thrombosis cases for $125,000 to $175,000 and pulmonary embolisms for $140,000 to 300,000. The amounts vary according to each woman’s circumstances.
Another lawsuit has been filed against the manufacturers of the gadolinium contrasting dye Omniscan on behalf of a 38-year-old Georgia man who contracted the disease Nephrogenic Systemic Fibrosis. General Electric Company’s Omniscan is a dye used to better define soft tissue in MRIs. The lawsuit includes GE’s subsidiaries GE Healthcare Inc., GE Healthcare Medical Diagnostics, GE Healthcare AS and Novation LLC. Nephrogenic Systemic Fibrosis is a condition that affects patients with kidney dysfunction who have been exposed to gadolinium dye. It is debilitating, progressive and can be fatal. The lawsuit alleges that Omniscan is defective, and that the defendants failed to adequately test Omniscan and failed to warn patients about its potential to cause NSF. Finally in September 2007, the Food & Drug Administration asked the manufacturers of gadolinium contrast dyes to add a “black box” warning, the most severe, to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents. NSF is a devastating condition characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include eye discoloration, red or dark patches on the skin, pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints. There is no known cure for NSF, however an experimental treatment called extracorporeal photopheresis has shown progress in three known cases of NSF. Extracorporeal photopheresis is a form of dialysis that involves treating the blood with photoactive drugs that are then activated when the blood is exposed to ultraviolet light. The blood is then reintroduced to the body effectively helping the body’s immune system fight the disease
A 25 year old woman in Oklahoma City believes she suffered a stroke caused by the Ortho Evra Birth Control Patch. At the time she was a restaurant manager and working the day she believes she suffered the stroke. She remembers she started to feel shaky and dizzy. When she answered the phone incoherent words came out in slurred speech. As with most young women who use the patch, she was perfectly healthy with no history of family health problems. After her stroke she researched the side effects and found that stroke was one of them. She had no idea how dangerous it could be and said she didn’t remember her doctor telling her of the possible dangers when she was prescribed it. More than likely her doctor gave the usual speech on possible, but improbable side effects of birth control use. Not the increased risk with the patch at 3 times the dosage of hormones compared to birth control pills.
A New York mother started using the Ortho Evra patch in March 2005. In January 2007 she suffered an aneurysm. Before her aneurysm, she was fit and exercised regularly and had no blood pressure problems. Two months prior she started having headaches daily. She awoke from a coma in the hospital three months later. Her doctor told her never to use the Ortho Evra patch again. According to the website HealthLink, “Brain aneurysms can occur in anyone, at any age. They are more common in adults than in children and slightly more common in women than in men…Some investigators have speculated that oral contraceptives may increase the risk of developing aneurysms.” If that is the case how much more does the patch increase risk since it dispenses 60% more hormones into the bloodstream.
The U.S. Food and Drug Administration has blocked the import of generic drugs made by the Indian company Ranbaxy Laboratories Ltd. citing violations encountered during an inspection earlier this year and poor quality in two of its factories. The generic drugs affected include the generic version of the antibiotic Cipro and cholesterol pill Zocor as well as any pharmaceutical ingredients made at the two plants in India. Further blocked drugs are the antibiotics clarithromycin, the antiviral acyclovir, the cholesterol drugs simvastatin and pravastatin and the diabetes drug metformin. During investigation of the two plants the FDA found violations that could lead to contamination, allergic reactions and other problems and Ranbaxy has not taken the proper steps to correct them, said Deborah Autor, director of FDA’s compliance office. In addition to the import block the FDA said it won’t approve any new products for sale by Ranbaxy until the manufacturing violations are corrected. India has become one of the world's leading suppliers of generic drugs, and concern about Ranbaxy has been growing since FDA inspectors first uncovered quality problems at one of its factories in 2006. However, the FDA told consumers not to worry and not to quit using the generic drugs because as yet repeated testing has found no evidence of contamination, just the threat of them if factory conditions don’t improve. Also, it would be hard for a patient to tell if drugs were made at the suspect factories or at one of Ranbaxy's numerous other factories in 11 countries.
Canada and the United States have had their share of brushes with death and disability linked to outbreaks of Listeriosis in packaged foods, Salmonella in peanut butter, spinach and jalapenos, Clostridium difficile in hospitals and exposure to defective medicines and medical products. All of which come from improper handling, manufacturing or just plain negligence. In an environment where people are being put in danger time after time and live in a state of fear of the next contamination a line needs to be drawn. The companies, hospitals and manufacturers need to know that negligence and poor oversight cannot continue as business as usual because business as usual is killing people. Until such a time that they start to take responsibility for their product, whether it is a service or a consumable, the people need to take the lead and seek an advocate in their fight against irresponsibility. That advocate is an attorney who because of the state of affairs in the corporate arena has ample experience in fighting the giants.
Those who have taken the rheumatoid arthritis drugs Enbrel, Remicade, Humira and Cimzia may be at risk of possibly fatal fungal infections. So far 240 cases have been reported to the U.S. Food and Drug Administration who have developed the fungal infection histoplasmosis of which 45 have died so far. That is a 20 percent fatality rate! The FDA has ordered stronger warnings for the immune suppressant drugs because the drugs lower the body’s defenses to fight various kinds of infections. The FDA's Dr. Jeffrey Siegel became concerned when it was discovered that doctors seem to have been overlooking these types of infections. The infection mimics the flu and is prevalent in much of the middle part of the country. It can have particularly grave consequences if it isn't caught early and spreads beyond the respiratory system to other organs of the body. Siegel said the investigation began with the case of a woman taking one of the drugs who died of histoplasmosis. After her death FDA officials searched the agency’s database and found an additional 240 cases of fungal infections. Of the 240 cases, 21 of them were late in being diagnosed of which 12 eventually died. That’s more than half! Dr. Siegal announced that the FDA has ordered a “black box” warning, the most severe, to be added to the drugs packaging informing the public about the risk of infections. If patients develop a persistent fever, cough, shortness of breath or fatigue, the FDA is encouraging them to seek medical attention as these are the symptoms of the fungal infection.
Those who have taken the rheumatoid arthritis drugs Enbrel, Remicade, Humira and Cimzia may be at risk of possibly fatal fungal infections. So far 240 cases have been reported to the U.S. Food and Drug Administration who have developed the fungal infection histoplasmosis of which 45 have died so far. That is a 20 percent fatality rate! The FDA has ordered stronger warnings for the immune suppressant drugs because the drugs lower the body’s defenses to fight various kinds of infections. The FDA's Dr. Jeffrey Siegel became concerned when it was discovered that doctors seem to have been overlooking these types of infections. The infection mimics the flu and is prevalent in much of the middle part of the country. It can have particularly grave consequences if it isn't caught early and spreads beyond the respiratory system to other organs of the body. Siegel said the investigation began with the case of a woman taking one of the drugs who died of histoplasmosis. After her death FDA officials searched the agency’s database and found an additional 240 cases of fungal infections. Of the 240 cases, 21 of them were late in being diagnosed of which 12 eventually died. That’s more than half! Dr. Siegal announced that the FDA has ordered a “black box” warning, the most severe, to be added to the drugs packaging informing the public about the risk of infections. If patients develop a persistent fever, cough, shortness of breath or fatigue, the FDA is encouraging them to seek medical attention as these are the symptoms of the fungal infection.
In another birth control tragedy a young man’s fiancée was killed and his 11-month-old son has lost his 22-year-old mother to a blood clot in her lung attributed to the use of the NuvaRing, a disk shaped hormone-delivery product that is inserted once a month then removed three weeks later. At the time of Katie Payne’s death her fiancé Anthony Greenfield did not link her collapse in the driveway and death to her choice of birth control until the coroner deputy asked him whether she had used it. His questioning grew so he went online to research more and found many more stories of deaths, illnesses and lawsuits. Katie Payne had just returned home with her son after a trip to the gym. Once she settled him inside she went back out presumably to get his diaper bag, said her stepfather, Jody Cline. Her collapse was recorded by a home security system then a passing neighbor found her soon after. Now her family wants to alert other young women of the dangers of certain kinds of birth control. “I know this killed her,” said her mother, Belinda Payne-Cline. “If they can't do better research or get it off the market, then … the information needs to be more in depth about what can happen.” If no other cause for the clot is found, her death could enter federal databases as another adverse effect of NuvaRing. Last year, the consumer group Public Citizen asked the Food and Drug Administration to ban oral contraceptives containing desogestrel, a variant of one of the hormones in NuvaRing, because some studies showed it doubles the risk of blood clots. NuvaRing's web site and product information warn that one of its hormones, a kind of progestin, may cause more clotting than the progestin in some birth control bills, but it discloses that the difference in risk between the ring and some birth control pills is unknown.
On August 29th Judge Ronald L. Buckwalter, of the United States District Court for the Eastern District of Pennsylvania submitted a 53-page opinion on the ruling associated with Garrison v. GlaxoSmithKline (GSK) case. As background information, Jake Garrison, 16, was taking the drug Paxil, an anti-depressant and anti-anxiety drug when he committed suicide. The parents filed a lawsuit against GSK the manufactures of Paxil. GlaxcoSmithKline attempted to use a preemption argument, which simply means that if the U.S. Food and Drug Administration has approved a drug or product for use then any litigation brought against the manufacturer for adverse events associated with the drug or product should be dismissed because of said FDA approval. GlaxcoSmithKline’s attempt failed as Judge Buckwalter issued the arguments:
Continue reading "Big Pharma Loses in using Drug Preemption Immunity" »
In the wake of a number of injuries occurring after the use of gadolinium contrast agents before an MRI, the U.S. Food and Drug Administration has approved a Fast Track Designation for a new type of contrast agent, ferumoxytol. Gadolinium contrast agents have been strongly linked to the debilitating and sometimes deadly disease Nephrogenic Systemic Fibrosis. Those who have suffered from this disease have previous renal failure in their kidneys. The gadolinium contrast agent is unable to evacuate from the body of an impaired renal system as quickly as those without. The FDA reserves the Fast Track Designation for products intended in the treatment of serious or adverse conditions or have the potential for use in previously unmet needs. This designation helps to accelerate the process of development and review of these products. The quicker approval process of ferumoxytol is driven by the potential that this newer diagnostic agent will be a safe alternative for individuals with chronic kidney disease.
A Tennessee attorney was contacted by a family who believed their loved one died from the overdose of digitalis, the main ingredient found in the heart drug Digitek. In the last few months a number of reports have been made to the U.S. Food and Drug Administration concerning the adverse events people have been experiencing. The drug Digitek was recalled because of a manufacturing error that doubled the thickness, thus the dosage of the heart drug. According to the family, doctors told them they weren’t sure why the person had died. It wasn’t until the family heard about the recall did they make the connection. The manufactures have yet to inform the public how long the production glitch occurred which would give patients and doctors a time frame to be concerned about. Many people found out about the double dosage when they went to have their prescription refilled and the pharmacist informed them of the recall. An Associated Press story reported earlier that Actavis, Digitek manufactures, was asking pharmacists and hospitals to return all prescription drug products made at one of its facilities because it did not pass health authorities’ standards. An inspection of the New Jersey facility by FDA officials “revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices,” read a statement issued by the company and printed in the story.
Many lawsuits have been filed in recent months involving two recalled drugs, the blood thinner heparin and the heart drug Digitek. What sets these apart is the link between the recalled drugs and China, who has been at the center of a number of recalls including toys, pet food and toothpaste recently. In past pharmaceutical litigation, plaintiffs’ lawyers alleged a “failure to warn” about possible risks of a drug that caused injury and death. The heparin suits are the first to be brought against a pharmaceutical manufacturer with ties to China. More than 40 lawsuits have been filed against the manufacturers of heparin so far and the number is expected to climb. In the past six months, about a dozen manufacturers, primarily Baxter International Inc., as well as their distributors and suppliers, have recalled much of the nation's supply of heparin after a contaminant was discovered in the drug linked to allergic and sometimes deadly reactions. The contaminant was tied to a supplier in China. According to the FDA, 124 deaths have been associated with the contaminated heparin. “This is going to be the tip of the potential iceberg in terms of Chinese manufacturing and drugs,” said attorney William M. Audet, a plaintiffs lawyer who has brought several drug cases and anticipates filing up to 60 lawsuits involving heparin and Digitek.
Continue reading "Recalled Drugs May Target China in Lawsuits" »
The U. S. Food and Drug Administration is harnessing the power of the internet in an effort to inform tech and online savvy folk of any complications or health concerns such as those experienced after using a defective drug or product. Their most recent post was targeted at young women between the ages of 15 and 44. Almost two months ago a YouTube video was targeted at warning this population of the dangers of venous thromboembolism and the use of the Ortho Evra Patch. So far three such videos have been posted. This is the latest move by the FDA in a campaign to improve public awareness about the dangers of the patch. The videos include information about two studies done previously that show an increased risk for life-threatening side effects among women aged 15 through 44. The more recent YouTube video focuses on the recent label changes brought about by the two studies, both of which show that women in this age group are at an increased risk for blood clots. The YouTube video also encourages women to talk to their health care provider before electing to use the patch. The question remains whether this latest move by the FDA will be effective enough in protecting future young women. According to the YouTube presentation, the video has only been seen 113 times since it was posted July 2 and that includes the visit that brought about this blog. TV commercials have not been informative enough in explaining the risks. It would seem that women are still finding out about the dangers after they have already been to the hospital for treatment of the side effects. ">Ortho Evra Patch. So far three such videos have been posted. This is the latest move by the FDA in a campaign to improve public awareness about the dangers of the patch. The videos include information about two studies done previously that show an increased risk for life-threatening side effects among women aged 15 through 44. The more recent YouTube video focuses on the recent label changes brought about by the two studies, both of which show that women in this age group are at an increased risk for blood clots. The YouTube video also encourages women to talk to their health care provider before electing to use the patch. The question remains whether this latest move by the FDA will be effective enough in protecting future young women. According to the YouTube presentation, the video has only been seen 113 times since it was posted July 2 and that includes the visit that brought about this blog. TV commercials have not been informative enough in explaining the risks. It would seem that women are still finding out about the dangers after they have already been to the hospital for treatment of the side effects.
A lawsuit has been filed against Actavis Totowa on behalf of a woman who lost her husband to the defective drug Digitek in Denver. The lawsuit charges that the pharmaceutical company distributed the defective Digitek heart drug pills that contained dangerously doubled dosages of the drugs’ active ingredient digoxin. Digitek is used to treat irregular heartbeat or heart failure. The woman alleges the defective pills caused the death of her husband in August 2007. This was more than a year after FDA inspections of the manufacturing plant revealed they failed to comply with federal regulations to ensure the safety of its medications. The FDA issued a Revised Warning Letter to Actavis Totowa, LLC on February 1, 2007 finding that the inspection of the company's Little Falls, New Jersey facility that took place July 10, 2006 through August 10, 2006 revealed that drug products manufactured at that facility were adulterated under the meaning of the Federal Food, Drug and Cosmetic Act. In April 2008 the FDA recalled the double dosed drug after a number of deaths and adverse events. In August the widowed wife filed the federal lawsuit in the United States District Court in Denver, Colorado
On a website as a service of the U.S. National Library of Medicine and the National Institutes of Health is a report on the clinical findings of three individuals treated with extracorporeal photopheresis who were afflicted with Nephrogenic Systemic Fibrosis. NSF has been strongly linked to the use of gadolinium contrasting dyes used in MRIs and those experiencing renal or kidney dysfunction. Up until this report no known treatment was available. NSF is characterized by the severe stiffening of joints and skin often causing the victim to be handicap-chair bound and can even cause death. The experimental treatment has shown that in each of the three cases mobility improved. Extracorporeal photpheresis treatment is a form of dialysis that involves treating the blood with photoactive drugs that are then activated when the blood is exposed to ultraviolet light. The blood is then reintroduced to the body effectively helping the body’s immune system fight the disease. At the end of four cycles of ECP all three patients showed a clinical response with the softening of the skin. At the completion of the treatments all experienced improved range of motion in all four limbs. The researchers are confident this may well prove to be an effective treatment of a previously untreatable and sometimes terminal condition.
A lawsuit has been filed on behalf of a woman who suffered from digitalis toxicity in Birmingham, Alabama after ingesting a tablet of Digitek with twice the amount of digitalis contained in it. Digitek is typically prescribed to treat irregular heartbeat or heart failure. Actavis Totowa and their heart drug Digitek is at the center of the latest recalled drug action by the U. S. Food and Drug Administration. The litigation alleges the double thickness and dosage of the defective Digitek caused her to suffer digitalis toxicity resulting in an adverse reaction including a drop in heart rate, blindness, confusion and incoherent speech. She was hospitalized for more than a month and underwent surgery to implant a heart pacemaker to treat the permanent heart damage she suffered in what is believed to have been caused by the Digitek overdose. The victim's injury occurred only a few weeks prior to April 25, 2008 when the FDA announced a nationwide recall of all Digitek tablets. The suit blames Actavis for failing to heed FDA warnings in July and August of 2006 and February of 2007, that many of the drug products that were produced, manufactured and released to the public by Actavis were adulterated and as a result the drugs were not “the identity, strength, quality and purity they purport to possess.”
An east Texas woman was prescribed three years ago the heart drug Digitek because of a heart murmur she has had since she was a young girl. After being on the drug for some time, Linda Brinkley began suffering major side effects. Her heart was beating fast, she was shaking, experienced severe headaches and nausea. The complications ended up sending her to the hospital three times between February and April. The last time in the ICU she started coughing and could barely breathe right before she passed out. Later she was told that she had flat-lined, effectively dying on the table. After being brought from the edge of death her doctor informed her it was not her heart condition that caused it, but the medication she was taking for it. She had been taking the drug for a little over a year. Linda is now in the process of filing a lawsuit and she is one of 1,500 Digitek claims in her attorney’s office. A panel of judges is meeting at the end of the month to decide where the claims will be consolidated
Nine lawsuits have been filed in the U.S. District Court of Newark in New Jersey alleging the drug Digetek was dangerous and defective. One of the lawsuits includes the death of one patient after taking the drug. The lawsuits have been filed against Actavis Totowa LLL and its Iceland-based parent, Actavis Group, a generic pharmaceutical company. Similar lawsuits have been filed in West Virginia and California. The Distributors Mylan Pharmaceuticals Inc. and UDL Laboratories Inc. have also been named defendents. A nationwide recall of Digitek was instituted on April 25 when it was discovered that the pills were double the thickness thus double the dosage. A double dosage of Digitek poses a risk of digitalis toxicity resulting in symptoms of nausea and dizziness, low blood pressure and cardiac instability. The company informed the public that death can result as well and that they had received several reports of injuries.
Drug makers are starting to feel the pinch from the removal of their defective drugs from the market. It is cutting into their profits and delaying their chances of making money on new blockbuster treatments. Big Pharma is blaming the fact that it is taking longer for the Food and Drug Administration to approve their new drugs. For example Merck & Co executives, the recalled http://www.burgsimpson.com/vioxx.html manufactures, say they are facing a tough new regulatory climate that is delaying drug development. Over the last 16 months, Schering-Plough Corp. has pulled the plug on two drug development projects, one for obesity and the other for cholesterol, and considering pulling a third project. Chief Executive Fred Hassan believes the reason lies in the intensified focus on safety and the diminished tolerance for side effects. With the diabetes drug Avandia causing an increase of heart failure in some patients and the Ortho Evra birth-control patch causing blood clots and in some cases death, is it a wonder the FDA is taking longer? Drug companies are required to clear their new drugs with the FDA. If they want their products to come to market faster they need to focus their attention on screening their own products so that there is assurance that good and safe drugs are being released to the industry rather than making money.
http://www.burgsimpson.com/digitek.htmlIn what may be the first Digitek product liability lawsuit has been filed in the Michigan Supreme Court. The class action drug product liability suit is seeking damages in excess of $75,000 from Digitek manufacturers the Activis Group. Digitek is the brand name for the heart drug digitalis. During the manufacturing process the tablets were created double strength. There was an Food and Drug Administration recall shortly thereafter. An overdose of digitalis can result in death from ventricular arrhythmia, or heart block. Non-fatal complications include nausea, vomiting, severe weight loss, diarrhea, mental confusion, vision changes and elevated blood pressure, which can lead to cerebral strokes.
In recent months bisphosphonates such as Fosamax and Boniva have been linked to an unusual bone fracture called femoral stress fracture. A recent small study found that those who take Fosamax may be actually slowing the healing of stress fractures. The study followed 70 people of which 76 percent of them suffered a femoral stress fracture compared to 2 percent who did not take the drug. “While bisphosphonates like Fosamax have been proven to successfully treat osteoporosis and other metabolic bone diseases, we believe long-term use of these drugs may suppress the ability of bones to heal in some patients,” said the study's lead author, Dean Lorich, of New York-Presbyterian Hospital/Weill Cornell Medical Center. The findings are reported in the latest issue of the journal Orthopaedic Trauma. The researchers feel that the use of bisphosophonates can strengthen bones enough to prevent devastating hip fractures, but they also suggest that patients may benefit from taking brief respites between dosages, thus giving their system a “holiday” from the medicine.
In response to pressure from the consumer group Public Citizen the U.S. Food and Drug Administration has added a “black box” warning to the family of antibacterial drugs called flouroquinolone. The use of Cipro, made by Bayer and Levaquin made by Ortho-McNeil may lead to tendon ruptures, a serious injury that can incapacitate patients and increase the possibility of extensive surgery. Some of the ruptures reported to the FDA occurred without warning when the patient felt a snap or pop soon after starting treatment suggesting that flouroquinolone antibiotics may be toxic to some people, the FDA said. Typically, patients felt some kind of pain or inflammation for a week or two before they suffered a tendon rupture. The link between the treatment of the antibiotics and the tendon ruptures is highly unusual and scientists still don't fully understand why it happens. The FDA further added that the risk of tendon ruptures decrease if patients stop taking the drug at the first sign of pain or swelling. Public Citizen petitioned the FDA nearly two years ago to add more effective warnings and feel the regulators took too long to act citing many injuries, “would have been prevented if patients and doctors had known a pain in the tendon is an early sign that leads to rupture,” said Sidney Wolfe, head of the consumer group. In defense, the FDA pointed out that the prescribing literature already carried clear warnings regarding the risk of tendon ruptures, but decided to emphasize the warnings because of continued reports of injuries indicated the public may not have been paying enough attention. FDA officials said they had received several hundred reports of tendon ruptures. Wolfe, of Public Citizen, said the number was 407 at the end of 2007, with another 341 reports of tendinitis. He continued to criticize the agency, saying it should also require drug makers to send individual letters to doctors about the risks. FDA officials said manufacturers could choose to send such letters on their own. The FDA’s analysis revealed that patients who are over 60, those on steroids, or patients with kidney, heart and lung transplants are at the highest risk of tendon rupture.
A lawsuit has been filed on behalf of a 20-year-old who is brain damaged after receiving an intravenous injection of a contaminated heparin and saline solution. Kyle Pacheco had already beaten leukemia as a young teenager after receiving a bone marrow transplant in 2006. He had a new lease on life. He and his family were in San Francisco, where he watched his mother complete a marathon as part of the Leukemia & Lymphoma Society's Team in Training. A month later he received the contaminated heparin medication to prevent his body form rejecting the bone marrow transplant. Shortly after, Pacheco developed a high fever and was vomiting post infusion. He was diagnosed with sepsis, a severe infection caused by bacteria in the bloodstream. The infection spread to his brain and he lapsed into a coma that lasted over a month. Today he lies in a hospital bed brain damaged. Kyle’s parents filed suit against Chicago based AM2PAT Inc. the maker of the pre-filled heparin syringes and Maryland based Maxim Healthcare Services Inc. the distributors. The tainted syringes were determined to be contaminated with Serratia marcescens, a dangerous and potentially lethal bacterium. Raw heparin is derived from pig intestines and is often processed by small, unregistered mom-and-pop workshops in China before being shipped for further processing and sale. The drug is used to thin blood and prevent clots during certain types of surgery. Kidney patients typically get heparin before undergoing dialysis as well as patients like Pacheco who are continually on intravenous treatments, so that clots don't form in the IV line. Since December the contaminated heparin has been linked to 149 deaths so far in the United States according to the Food and Drug Administration. Fortunately, all batches of contaminated heparin are believed to have been pulled and the FDA now feels the country’s current supply is safe.
A Miami woman began taking Boniva to help strengthen her bones. She was once an active woman, but now she suffers debilitating pain and needs help with the slightest of movements. When she told her doctors of the complications she was experiencing and asked if her incapacitation was due to her Boniva use, all the doctors said no. A few weeks later the Food and Drug Administration issued a warning to doctors alerting them that Boniva and other bisphosphonates could cause the type of bone pain she was experiencing. The manufacturer of Boniva, Roche, stated, “The risk factors for and incidence of this effect is unknown; such reports have been infrequent.” According to Doctor Phuli Cohan, “There is actually bone death occurring,” backing up her statement with the X-rays of another woman whose hip shattered after years on Fosamax, another brand of bisphosphonate. Merck, the maker of Fosamax, maintains no such link has ever been proven between the use of their drug and the debilitating pain and fractures occurring. Apparently, some doctors are encouraging their patients to stop taking the drug for a time to allow bone cells to rejuvenate. Dr. Cohan notes that this drug has only been on the market for about a decade, and the long term side effects are not known. She says she had feared seeing spontaneous fractures in patients and that “my worst fears have been realized.”
According to an article in the latest issue of the Journal of Orthopaedic Trauma a study links bisphosphonates to risks in a type of fracture after long-term use. Bisphosphonates such as Fosamax, Boniva and the generic alendronate are used to treat osteoporosis by increasing bone density in order to prevent fractures. The findings were reported by Dr. Dean G. Lorich and Dr. Joseph M. Lane of New York Presbyterian Hospital/Weill Cornell Medical Center. “While bisphosphonates like Fosamax have been proven to successfully treat osteoporosis and other metabolic bone disease, we believe long-term use of these drugs may suppress the ability of bones to heal in some patients. As a consequence, patients with routine stress fractures are unable to properly heal, and minor damage can worsen until a serious fracture occurs,” said Dr. Lorich, the study's senior author. In the study 70 patients were followed of which 25 were taking Fosamax for an average of five years. Among those, 19 patients or 76 percent suffered a femoral stress fracture. While this type of fracture results in little or no trauma the study calls into question the efficacy of the family of bisphosphonate drugs. Dr. Lane suggests, “While more research is necessary to confirm our results, physicians prescribing bisphosphonates for longer durations should monitor patients for indications of bone regeneration. In situations where a blood test reveals low bone turnover, a holiday from the bisphosphonates would be recommended until these markers return to an acceptable level.”
Despite strong warnings to physicians, the FDA says that drugs injected into patients to improve medical images of the heart are still linked to serious side effects and some deaths.
Continue reading "FDA Warns of Serious Side Effects of Heart Imaging Drugs" »
After receiving 30 reports of children and young adults developing cancer
while taking arthritis drugs over the last 10 years, the FDA is investigating
to see if there is a link, especially for younger children.
The drugs under investigation include:
Humira (Abbott Labs)
Remicade (Shering-Plough)
Enbrel (Amgen Inc. and Wyeth)
Cimzia (UBC, Belgium)
Continue reading "FDA Reviews Arthritis Drugs for Links to Childhood Cancer" »
Following the Food and Drug Administration’s Class I recall of the heart drug Digitek a class action lawsuit has now been filed in California. The plaintiffs include a California man and other individuals suffering from heart disease who unknowingly took a double dose of Digitek causing a dangerous elevation in their heart rate. The lawsuit has been filed against the manufacturers, distributors and marketers of Digitek: Actavis Totowa, LLC in New Jersey, Actavis Group PTC in Iceland, and Mylan Bertek Pharmaceuticals in Texas. According to the lawsuit, neither the male patient nor his physician knew the Digitek medication was twice the standard dosage. The class action law suit alleges that, “Digitek is defective and unreasonably dangerous to consumers.” It also alleges that the defendants “sold, released, produced, and distributed of Digitek without making proper and sufficient tests to determine the drug's strength/dose,” and that they were “negligently representing that the recalled Digitek was safe for use for its intended purpose, when, in fact, it was not.” Digitek is used by millions of heart patients worldwide. Digitek is a brand name of the generic drug digoxin (also known as Digitalis). Digoxin is a purified cardiac glycoside extracted from the foxglove plant, Digitalis lanata. Digoxin toxicity can cause potentially life-threatening heart rhythm disturbances, as well as nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, visual disturbances, low blood pressure, cardiac instability, irregular pulse, heart palpitations and bradycardia. At its most severe, death can result from excessive digoxin intake.
The consumer advocacy group Public Citizen is suing the U.S. Food and Drug Administration claiming the prescription painkiller sold as Darvon and Darvocet is too risky to remain on the market. Since 1981 more than 2,000 deaths have been associated with the drug, generically known as propoxyphene. Public Citizen originally petitioned the FDA two years ago seeking a ban on the drug, saying it was no more effective than safer painkillers. Public Citizen filed suit in U.S. District Court in Washington arguing that the FDA has violated the law by not ruling on its petition within the required six months. Propoxyphene is addictive and can cause slowed heart beat and other serious cardiac issues even when the proper dosage is ingested. Health Officials in the U.K. have already ordered the drug to be phased out in 2005 citing a few hundred accidental deaths and suicides a year associated with the drugs use. In the U.S. propoxyphene still remains one of the most widely prescribed generic drugs.
Following the recall of the high dose double thick tablets of the Actavis drug Digitek, a lawsuit has been launched. The suit is on behalf of the lead plaintiffs including a Pennsylvania man who said the drug caused kidney damage and an Illinois woman who said she suffered nausea, dizziness and cardiac symptoms. The three drug companies facing the lawsuits are Actavis Totowa, distributor Mylan Pharmaceuticals and UDL Laboratories. Lawyers have filed three lawsuits thus far, but expect more to follow. The lawsuits argue that the pills were manufactured with undetected high doses of digitalis, an active ingredient that led to serious illness and even death in some cases. Digitek is used to treat heart failure and abnormal heart rhythms, but excessive doses can lead to digitalis toxicity, which in extreme cases can lead to cardiac arrest according to the FDA recall notice. “It was supposed to treat the symptoms of congestive heart failure, and the tragic thing is that it turned around and caused congestive heart failure in some cases,” said lawyer James Peterson, one of the attorneys involved in the case. The initial recall was announced April 25 and said that the tablets may contain twice the appropriate level of digitalis. At the time of the recall, Actavis knew of 11 people who had reported becoming ill after taking the drug. Tony O'Dell another lawyer involved in the case, points to a 2007 Food and Drug Administration letter to Actavis as indication of persistent problems. The letter, based on inspections in the summer of 2006, concludes in part that “significant deficiencies were found in the operations of your firm's quality control unit.” In response O’Dell said, “It's going to be difficult for this company to argue they were unaware of quality control problems at their plant.
The Food and Drug Administration issued a recall earlier in the week of a voluntary recall ETHEX Corporation’s single lot of morphine sulfate 60 mg extended release tablets due to a report of a tablet with twice the appropriate thickness. The oversized tablets could contain up to two times as much active morphine sulfate. An overdose of morphine sulfate could cause life threatening consequences such as difficulty of lack of breathing and low blood pressure. For those the product have been prescribed may already be experiencing a debilitating loss of strength and energy and drug impairment, thus causing the inability to recognize the oversized tablet. The recalled lot has a label between April 16th and April 27th of 2008.
The Quebec Superior Court has given approval for a class-action lawsuit against the pharmaceutical company Pfizer Inc. and its subsidiary, Pfizer Canada Inc. regarding their contraceptive drug Depo-Provera. Depo-Provera is an injection administered every three months that can be used to treat women with endometriosis and breast and endometrial cancer in menopausal women as well as used as a contraceptive. The $50 million class action suit claims that Pfizer knew that Depo-Provera could cause a decrease in bone density in women using it. The representative plaintiff, Noelia Brito, had her bone density tested seven years after she began using the drug. The test revealed that the 37-year-old had the bone density of a 70-year-old. In a June 2005, public notice, Pfizer admitted that two clinical studies indicated that women using Depo-Provera might be subject to a considerable reduction in their bone mineral density. Daniel Belleau, who is representing the plaintiffs, guessed that possibly thousands of women will come forward in the lawsuit because in the last five years, 3 million prescriptions for Depo-Provera have been filled. While it has long been known that Depo-Provera causes bone loss, it has been discovered that the bone loss grows worse the longer the drug is used and may remain long after the injections stopped and could even be irreversible. For these reasons the FDA in agreement with Pfizer in November 2004 agreed to put a black box warning on the label. Pfizer and the FDA recommend that Depo-Provera not be used for longer than 2 years due to concerns over bone loss. Regardless of the steps taken to protect women with the black box warning long after its initial approval and release, Pfizer allegedly knew of the bone loss and released it for general consumption. Depo-Provera was approved by the FDA in 1992.
The Food & Drug Administration issued a Class 1 recall, the highest rating, for all strengths of Digitek (digoxin). The drug is used for the treatment of various heart conditions, namely atrial fibrillation, atrial flutter and sometimes heart failure that cannot be controlled by other medication in human and animal patients. The nationwide recall was initiated when the product was made double the appropriate thickness thus possibly containing twice the approved level of the active ingredient. The double strength tablets pose a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported to the FDA. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The original voluntary recall occurred in late April. By mid-May a Safety Warning and Recall Notification had been sent out to Veterinarians who use the human drug to treat their animal patients.
The Food and Drug Administration (FDA) has issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals about a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. The FDA is currently investigating about 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.
In an effort to protect women the consumer advocacy group Public Citizen recently petitioned the Food and Drug Administration to have the Ortho Evra Patch taken off the market. Makers of the patch, Johnson & Johnson are facing legal troubles with civil action lawsuits being filed against them by 3,000 families of women affected. Dr. Waverly Peakes an Ob/Gyn at the Methodist Hospital in Houston, TX points out, “We know that at all times in our lives when we have elevated estrogen we are at increased risk of blood clots, which can be fatal if in the lungs or brain. So even in pregnancy we are all at this elevated risk,” says Peakes. In response to the controversy however, Dr. Peakes has not been prescribing the patch over the last year because of the reported risks associated with its use. While she hopes that further investigation makes a clear and concise conclusion, she believes the risks are too great as of now. “There are too many other options for birth control that the patch should not be given until this is figured out,” Peakes says.
The widely prescribed osteoporosis drug Fosamax in addition to possibly causing worse problems with bone fracture has now been linked to atrial fibrillation, a type of rhythm disorder that causes the heart to beat erratically. Researchers have now found a link between the drug and AF. Although AF is not fatal, it can cause the blood to pool and form potentially dangerous clots. Researchers led by Professor Susan Heckbert from the University of Washington in Seattle studied 719 women diagnosed with AF over a three-year period. They were compared to random AF free woman. More that 6 percent of the AF patients had taken alendronate. Fosamax is also known as alendronate and marketed by the pharmaceutical company Merck & Co. “Having ever used alendronate was associated with an 86 percent higher risk of newly-detected atrial fibrillation compared with never having used the drug,” said Professor Heckbert. She also believes that women who with higher risk of fractures, but also have risks for AF, such as heart failure, diabetes or coronary disease, might want to discuss alternatives to the drug. Why Fosamax might increase the chances of AF is unclear, but bisphosphonates may disrupt regulatory proteins, trigger inflammation and cause small decreases in blood calcium and phosphate levels. The findings are reported in the journal Archives of Internal Medicine.
Joanna Bonfillio spends most of her time helping her mother who lives in constant pain. “Brutal, brutal pain in my right hand and wrists,” said Edna Polcari, Joanna's mother. Edna lived an active life before she started taking Boniva, a drug that helps make bones stronger. Just weeks after she asked one doctor after another if her pain was associated with Boniva, the FDA issued a warning alerting them that Boniva and other bisphosphonates could cause bone pain. “I have never prescribed these medications,” said Dr. Phuli Cohan, who treats her osteoporosis patients with vitamins and natural hormones. She says pain isn't the worst thing that can happen with bisphosphonates. “There is actually bone death occurring," said Dr. Cohan. A recent letter in the New England Journal of Medicine suggests long-term use of the drugs may actually increase the risk of fracture in some women. As an example she cited x-rays of a woman whose hip shattered after years on Fosamax, another bisphosphonate. “People don't want to believe that this is happening. But it is a side effect of the medicine,” said Dr. Cohan. The makers of Fosamax deny any such link has ever been proven.
Medtronic is initiating a voluntary recall of products featuring the Carmeda BioActive surface. This is in response to the U.S Food and Drug Administration’s recommendation to check any products that could contain the contaminated heparin linked to recalls early in the month of April. Affected products include blood oxygenators, reservoirs, pumps, cannulae and tubing packs. A limited number of lots of the Carmeda-coated products were manufactured with the oversulfated chondroitin sulfate contaminated heparin. So far 81 deaths have been associated with adverse reactions to the adulterated heparin as well as many reports of serious injury.
Public Citizen’s Health Research Group filed a petition with the Food and Drug Administration calling for the agency to remove the Ortho Evra Patch from the market within six months. They are citing data compiled that reveals Ortho Evra exposes women to more estrogen, doubles the increase in risk of blood clots and painful side effects. They call for the 6 month mark to ensure that women currently using the patch can make an appointment to discuss safer alternative contraceptive methods. “Had Ortho Evra been designed as a pill, it is unlikely to have been approved because of its increased estrogen content,” said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen. In 1988, the FDA requested the withdrawal of all oral contraceptives with estrogen levels greater than 50 mcg because of the risk of blood clots and lack of additional contraceptive efficacy. The Ortho Evra patch contains estrogen equivalent on average to a 56 mcg pill. The request for Patch prescriptions has dropped from 9.9 million in 2004 to 2.7 million in 2007, which is a decline of 73 percent. Even with the drop, Ortho Evra remains a common birth control prescription thus still posing a danger to a large number of women nationwide.
Dr. Christiane Northrup is a board-certified ob-gyn physician. She recently posted a blog on a site concerning biphosphonate drugs such as Fosamax (alendronate) and Boniva (ibandronate). She exhorts woman to fully understand the implications of taking the osteoporosis drugs. First, bones are designed to last a lifetime without drugs by constantly remodeling itself through the process of resorption of old bone and the laying down of new bone. It’s the bone quality not just bone density that is important and taking biphosphonate drugs puts the bone quality at risk. The biphosphonates work by preventing bone resorption and loss. By inhibiting bone resorption it inhibits the formation of new bone. Old bone is denser and more brittle than new bone. The density of the bone may make it more difficult for bone to maintain an adequate blood supply thus inhibiting bone healing. Research on animals indicates that biphosphonates inhibit the normal repair of tiny fractures and porous bone which eventually results in the accumulation of microdamage and loss of bone strength. This explains why alendronate has been associated with delayed or absent fracture healing. Secondly, biphosphonates have been linked with osteonecrosis of the jaw, a side effect in which the jaw bone deteriorates. Additionally, along with deterioration the drugs have been associated with increased need for root canals and other dental problems. In Dr. Northrup’s opinion, too many doctors are prescribing these drugs as a first line of treatment and it is irresponsible to prescribe them to relatively young midlife women to prevent osteoporosis. Plus, hormone replacement therapy used in menopause has already shown the ability to maintain bone integrity. There are other safe and effective alternatives that work naturally such as exercising, taking at least 1,000 IU a day of Vitamin D, Calcium with Magnesium supplements, a good multivitamin daily, stop smoking and limit alcohol intake.
In a study published in the April 28th issue of the Archives of Internal Medicine researchers from Group Health and the University of Washington reported chronic irregular heartbeat or atrial fibrillation, affected women who had taken the bisphosphonate drug Fosamax (alendronate) used to fight osteoporosis almost twice as much as those not using the drug. Study leader and professor of epidemiology and researcher at the Cardiovascular Health Research Unit at the University of Washington, Dr Susan Heckbert, said in a prepared statement, “We studied more than 700 female Group Health patients whose atrial fibrillation was first detected during a three-year period.” They found that women who used alendronate had an 86 percent higher risk of atrial fibrillation. Heckbert encouraged women who are at a high risk of fractures, but who also suffer from heart failure, diabetes or heart disease, to talk to their doctor about alternative treatments.
Three city councilors of Taipei called on drug administration authorities to investigate a case involving a 33-year-old woman who suffered a stroke and went into a coma after using the controversial birth control patch, Ortho Evra. She has not regained consciousness. Councilor Pan Hwai-tzong said sales of the patch should be banned in Taiwan because of the side effects reported in the United States and Canada. The patch, marketed as the Evra Transdermal contraceptive patch in Taiwan was introduced in 2004. Many of the victims in the U.S. were teenagers and young women of childbearing age who suffered strokes, heart attacks, pulmonary embolisms and deep vein thrombosis. U.S. news media have reported that the manufacturer has adopted a strategy to settle as many lawsuits as quickly and quietly as possible and at the same time keep the lucrative patch on the market for fear of losing billions of dollars in future sales.
Widows and widowers testified in front of a congressional subcommittee on how the contaminated Heparin has affected their lives. The blood thinner commonly used in dialysis and surgery has been connected to 81 deaths and 785 severe allergic reactions so far said Rep. Bart Stupack, D-Mich., chairman of the House Energy and Commerce subcommittee on oversight and investigations. The contaminated Heparin originates from ingredients imported from China. Baxter International and the Food and Drug Administration have blocked imports from the Chinese company at the center of the controversy. The FDA detected the drug was contaminated with oversulfated chondroitin sulfate, which imitates Heparin thus not being detected in routine testing. “FDA's working hypothesis is that this was intentional contamination, but this is not yet proven,” Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told the panel in her prepared testimony. One month after a man’s wife died from the contamination, his son was killed by the same tainted drug at the same clinic. Baxter president Robert L. Parkinson Jr., said in prepared testimony that his company is “greatly concerned that our heparin product appears to be the target of a deliberate adulteration scheme. The complexity of the global drug supply chain creates new and emerging risks that call for new ways of thinking about, identifying and addressing vulnerabilities, and that resting on old standards — even ones that have worked for decades — is no longer enough," Parkinson said.
A Class I recall, the most severe the Food & Drug Administration uses, has been initiated by Actavis Group for a product used to treat heart failure and abnormal heart rhythms. Actavis is recalling Digitek® (digoxin tablets, USP, all strengths) for oral use because of the possibility that the tablets are double the appropriate thickness thus may contain twice the approved level of the active ingredient. If a double strength tablet is ingested the risk of digitalis toxicity in patients with renal failure may occur. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia and possibly death. Several reports of illness and injury have been received by the FDA.
China and the U.S. Food & Drug Administration traded barbs on whether the contaminant found in the blood thinner Heparin was the link between 81 deaths triggered by severe allergic reactions. Federal health officials insisted new tests indicate a solid link. China argued the contaminant could not be the “root cause” of the problem. Raw Heparin is derived from pig intestines, often processed by small and unregistered workshops in China. The raw ingredients from the recalled Baxter’s heparin came from a Wisconsin-based Scientific Protein Laboratories which is known to own the Chinese factory, Changzou SPL, as well as buying additional raw Heparin from other Chinese suppliers. The FDA warned Changzhou SPL that it does not have an adequate system for ensuring that the raw materials it uses are free from any impurities. However, agency officials are still unsure at what point the deadly contaminant was introduced. The FDA also noted that as many as 12 companies in China are involved in the supply chain for Heparin. Hundreds of patients have suffered severe allergic reactions to the doses of the contaminated blood thinner. In its warning letter to the Chinese company, the FDA said it will recommend disapproval of any new applications listing the company as the manufacturer of any active pharmaceutical ingredient. It cited “significant deviations” from good manufacturing processes. Germany also discovered the contaminant and recalled batches of Heparin after some patient illnesses.
Based on an unpublished study, the Food and Drug Administration found potentially serious problems at Merck & Co.’s plant located in the Philadelphia suburbs. Contaminated children’s vaccines were among the 49 concerns cited by the federal regulators ranging from failure to follow good management practices to contamination of bulk lots of vaccine. Inspectors from the FDA visited the Merck plant between November 2007 and January 2008. In December, Merck recalled 1.2 million doses of its vaccine against Haemphilus influenza type B because of a sterility problem discovered in October and quarantined almost a year’s worth of other suspected doses. At this time the FDA has not ordered the plant to stop production while reviewing Merck’s responses to their report.
Patients at risk of renal failure or kidney disease have a new tool that can help radiologists determine the safety in use of Gadolinium in Magnetic Resonance Images. Gadolinium is a contrast agent used to highlight soft tissue in patients before an MRI. Gadolinium has been found to be linked to the devastating and sometimes deadly disease Nephrogenic Systemic Fibrosis in patients with renal failure or kidney disease. MEDRAD, Inc. has developed a handheld device called the i-STAT System that can be used to analyze patients’ blood on the spot and deliver results of a variety of diagnostics in less than 3 minutes. Test cartridges in the unit provide an array of nine metabolic tests in the measurement of renal function for those with diabetes, kidney insufficiency and advanced age. The i-STAT is expected to successfully predict patients’ risk for gadolinium induced Contrast Induced Nephropathy (CIN) and Nephrogenic Systemic Fibrosis (NSF). The device can thus help radiology departments more efficiently maximize safety and care.
An investigation conducted by the China National Institute for the Control of Pharmaceutical and Biological Products concluded that the contaminant found in the blood thinner heparin was not the cause of reported problems. Baxter International, Inc., the maker of the drug, recalled most of its heparin products in February due to reports of allergic reactions and death. Of the batches of heparin linked to problems, however, only some contained an altered form of chondroitin sulfate. The raw ingredient in heparin is manufactured in China.
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The manufacturers of Ortho Evra, Johnson & Johnson, are hoping to use a legal doctrine called preemption as a defense against claims that the birth control patch has caused blood clots and death. Their argument is that if a drug or medical device has been approved by the FDA than its safety cannot be questioned in individual lawsuits. An editorial from the New York Times revealed its belief that the FDA is sorely short of skilled scientists and overwhelmed by its responsibilities that they might miss detection of important information and clinical results. Also according to the editorial, J&J might soon “get a helping hand” from the U.S. Supreme Court, which has blocked many lawsuits over “faulty medical devices” such as the recent decision concerning Medtronic’s faulty leads in one of its defibrillators. The Times continues that preemption is a “perverse legal doctrine,” and if it “continues to spread, the public will be deprived of a vital tool for policing companies and unearthing documents that reveal their machinations.”
Manufacturing flaws have come to light in the production of the Ortho-Evra Birth Control Patch. Johnson & Johnson, makers of the patch, have already disclosed data on how the numbers were altered to make the patch look safe. The Food and Drug Administration were misled by the world’s largest pharmaceutical company about estrogen levels before and after patch sales began in 2002 according to the filing. It was found that manufacturing defects made the patch unstable and the dosage unpredictable. J&J’s manufacturing problems at its facility in Redwood City , California, caused variations in the rate of release of estrogen from the patch. The company also could not replicate in its commercial patch the results obtained in clinical trials because the levels of estrogen varied from batch to batch. Disclosure also revealed that J&J scientist, Patrick Caubel urged the company in 2003 to conduct epidemiology studies because of an abnormally high number of clotting disorders and death associated to patch use. The company hid those problems from the FDA. It is believed that Johnson & Johnson was desperate to get Ortho Evra to the market because it was losing patent protection on its best-selling birth control pill. The FDA was told by J&J that the patch was expected to release less estrogen than the pill, not more. A multitude of lawsuits have been settled by J&J including one awarding the family of a deceased 14-year-old patch user $1.25 million.
In 1996, Johnson & Johnson told the Food & Drug Administration it planned to develop the Ortho Evra patch because it would probably expose women to less estrogen than the standard birth control pills. The company suggested that the women’s body would not break down hormones delivered via the patch as quickly as the pill, so lower doses could be used. The truth was that the patch delivered considerably more estrogen into the bloodstream, a 1999 clinical trial concluded. The study suggested that since up to half of birth control pill’s estrogen is lost in the digestive track, the patch could deliver an amount of estrogen that could be as high as the pill at 76 micrograms. In 1988 the FDA banned birth control pills with more than 50 micrograms of estrogen. The study’s author, who has since retired from Johnson & Johnson, Dr. Larry Abrams, at the time applied a “correction factor” to the 1999 results claiming the patch, delivered 40 percent less estrogen than the trial results showed. According to Dr. Abrams deposition, the adjustment was never part of the study protocol that was filed with the FDA. Clinical trials conducted before the patch was approved showed patients complained of breast soreness and nausea and the side effects seem to be related to high estrogen doses, a company scientist wrote in an e-mail message. The 1999 study and another in 2003 confirmed that the patch delivered more estrogen than the pill. Once the patch was approved, Johnson & Johnson misrepresented it and informed the public it released only 20 micrograms. As the patch was prescribed more and its use rose, reports of side effects increased. By 2004 the death of an 18 year old in New York caused the food and drug officials noticeable concern. In 2005 it announced that it had included a new warning that the patch “exposes women to higher levels of estrogen than most birth control pills.” Since then, an epidemiological study showed women on the patch can have as much as double the risk of blood clots and stroke. Still, lawyers for Johnson & Johnson say that patients should not be allowed to sue the company because the FDA approved the patch and its label.
Results presented at an American College of Cardiology conference in Chicago Sunday, Mar 30th and published on the Internet by the New England Journal of Medicine announced that a key trial of Vytorin failed. Parallel to the report, leading doctors urged the return to the older, successful treatments for high cholesterol, such as statins. Results showed Vytorin failed to improve heart disease even though it worked as intended to reduce three key risk factors. “People need to turn back to statins,” said Yale University cardiologist Dr. Harlan Krumholz, referring to Lipitor, Crestor and other widely used brands. “We know that statins are good drugs. We know that they reduce risks.” Two Congresssional panels ordered investigations into why it took the drug makers almost two years after the study’s completion to release their results.
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The latest research on the bisphosphonate Fosamax shows that long-term use by women is associated with unusual fractures of the thigh bone. The fractures were low-energy, meaning they occurred from a fall at standing height or less. About one-third of women with the unusual horizontal pattern fractures had been using Fosamax on average more than seven years. “These were peculiar fractures that would occur when the women were basically doing nothing,” said the study's senior author, Dr. Joseph Lane, chief of metabolic bone disease at the Hospital for Special Surgery at Weill Cornell Medical College in New York City. Lane said there are several theories as to how the bisphosphonate could be related to the unusual fractures. One is that the drug slows down the development of new collagen which is very strong. Another could be because there is slower bone turnover on the medications. That could mean there may be accumulated micro-damage in the bone, making it more susceptible to fracture in certain women. Lane said that women who've been taking this medication for a long time and have test results that suggest low bone turnover, may want to stop taking the medication for a year but, added this shouldn't be done on their own. The U.S. Food and Drug Administration in January issued an alert to physicians about the possibility of severe bone pain occurring as a result of bisphosphonate therapy. Additionally, last year Fosamax was also implicated in some cases of atrial fibrillation, though the FDA hasn't found evidence to support this association.
The Food and Drug Administration recently announced it is investigating a possible link between the allergy and asthma drug Singulair and suicide. The investigation stems from reports of mood changes, suicidal behavior and suicide in patients taking the popular drug manufactured by Merck. This on the heals of four other updates to the drug’s labeling in the past year to include information of the reported side effects tremors, anxiousness, depression and suicidal behavior. The investigation was prompted by three to four suicide reports received since last October. The FDA has stepped up its notification procedures about possible safety issues when it was criticized for acting too slowly on information received on the risks of Merck’s painkiller Vioxx and GlaxoSmithKline’s diabetes drug Avandia. Singulair, first approved in 1998, is part of a class of asthma and allergy drugs that include AstraZeneca’s Accolate and Critical Therapeutic’s Zyflo. As in any situation when a drug has been called into question it is important to still seek medical counsel to determine risks associated for each individual case. "Patients should not stop taking Singulair before talking to their doctor," FDA said in a statement, adding that doctors should monitor patients for suicidal behavior and mood changes.
The class of biphosphonate drugs prescribed for osteoporosis has been known for some time to be linked to osteonecrosis, which is the breakdown of the jaw bone. Fosamax, Boniva and Actonel are the most prescribed drugs for osteoporosis. In knowing the risks it is encouraged to have regular six-month checkups including an examination and X-rays of the jaw. Most dentists are aware of the drugs’ side effects. People with osteoporosis on any of the biphosphonates are also at a bigger risk of developing mandibular necrosis following such dental procedures as tooth extraction. This can cause fracture of the jawbone as well and delayed healing and infections. Patients with breast cancer and prostate cancer often receive IV (infused) biphosphonate. This population is at much greater risk of osteonecrosis of the jaw. Other risk factors include existing dental disease, poor dental hygiene, anemia, infection or abnormal blood coagulation. Dentists are taking precautions now prior to treatment of patients using a version of a biphosphonate by encouraging them to take vitamin D and calcium supplements prior to a dental procedure in the hopes of reducing the risk of osteonecrosis. As is always encouraged if a patient develops jaw pain, joint or muscle pain, stomach upset, cramps or bloody stool while on a biphosphonate let the dentist know or contact a physician immediately.
The recall of Heparin sodium vial products has widened to include a broader recall of the product. American Health Packaging (AHP), subsidiary of the world’s largest pharmaceutical services companies AmerisourceBergen, announced a voluntary recall of 1,421 units (25 vials per unit) of heparin sodium injection vials. The vials were manufactured by Baxter then placed by AHP into individual labeled bags for use in pharmacy automation equipment. The packages were then sold to five hospitals in Georgia and California. Patients have experienced numerous side effects including abdominal pain, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnia, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, including profound and refractory hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, paresthesia (oral), pharyngeal adema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. The reports of profound and refractory hypotension usually occur with the first few minutes of bolus administration. It has been discovered that the recalled products contained oversulfated condroitin sulfate that were contaminated by manufacturers in China.
Late February certain lots of Heparin were recalled and have been associated with 19 deaths. The lots have also been linked to hundreds of allergic reactions and were marketed by Baxter International and produced in China. The Food and Drug Administration’s have identified the contaminant found as oversulfated condroitin sulfate. Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said “We cannot rule in or out whether this was accidentally or deliberately introduced into the product,” Woodcock said, “We are investigating how it got in.” Condroitin sulfate is a compound in the same family as heparin, so preliminary testing did not identify it, Woodcock said. A different brand of heparin has also been recalled in Germany after 80 patients there became sick, and the German manufacturer said preliminary research has linked the source of contamination to another Chinese supplier. Heparin is made from pig intestines and tiny Chinese family-run workshops near slaughterhouses send the raw ingredients for the manufacturer of Heparin to middlemen before they reach factories.
Rhonda Sloan, of Oakley, California, has had very few health problems in her life until recently. One Sunday she started to experience a shortness of breath and a pain in her chest. By Friday her doctor sent her in for a CT scan which illuminated a blood clot in her lung. Rhonda Sloan was using the birth control patch Ortho Evra at the time and believes that was the cause of her blood clot. "I didn't have any issues taking the pill, not getting sick or anything like that, and with the patch, it only took me three months to make me sick," Sloan said. Sloan is now one of thousands of American women suing Johnson & Johnson, the makers of Ortho Evra. She doesn't blame the doctor who prescribed her the patch. She holds Johnson and Johnson responsible. “They need to take more care about a human life, because I could have lost a life and my kids couldn't have a mother today," Sloan said. Sloan wants to get the word out to other women, especially teenagers. No Ortho Evra cases have gone to verdict, but several have been settled. Ronda Sloan says her attorneys expect her case to be settled sometime this year.
Late last year over-the-counter children’s cold and cough medicines were removed from consumer use because of increased risk of overdoses in young children. According to the Centers for Disease Control and Prevention, over-the-counter cough and cold medicines send an estimated 7,000 US children under the age of 12 to emergency rooms every year. At the time the U.S. Food and Drug Administration recommended that over-the-counter cough and cold medicines that contain decongestants and antihistamines should come with new instructions saying they are not for very young children. In response, a California mother has filed suit against Novartis AG, makers of Triaminic, who used the product on her 4-year-old son. It is not immediately apparent how it may have harmed her son. The lawsuit alleges that several studies have shown deaths and serious injuries linked to the children’s medicines. The lawsuit says that as a result, Novartis "either knew ... or reasonably should have known that their cough and cold products were ineffective and dangerous when used by children under the age of six." Novartis recalled Triaminic oral infant cough and cold medicines late last year and said that they believe this is the first such lawsuit filed against them.
The Food & Drug Administration concurred with a study from the Journal of American Medical Association concerning Amgen Inc. and Johnson & Johnson’s anemia drugs used in cancer patients. FDA advisors said the drugs should be sharply restricted to a certain population of cancer patients. Earlier, FDA staff told panelists there is no definitive evidence that the anemia drugs are safe when used as recommended. The drugs, Aranesp, Epogen and Procrit, are at the center of the study that shows increased risks of death and tumor growth in patients on them. A panel of cancer experts voted nine-to-five to withdraw the drugs use in patients with breast or head and neck cancers that affect the sinuses, throat and lymph nodes. Three times in the past year the FDA has strengthened the warning labels on the anemia drugs, Aranesp, Epogen and Procrit.
The Food and Drug Administration announced it has approved a Black Box warning to anemia drugs because of increased risk of death and tumor growth. The Black Box warning, which is the most extreme warning, will be added to Aranesp, Epogen, and Procrit. The drugs treat the blood-disorder in patients with kidney failure or who are undergoing chemotherapy. In November last year prior labeling was added to the drugs warning of similar risks in other types of cancers. Labeling approved by FDA said risks occurred when doctors treated patients with elevated levels of the drugs, which stimulate red blood cell levels. The announcement comes less than a week before government advisers are slated to meet to review the risks of the medications. Wall Street analysts expect sales to fall in 2008. The panel may recommend halting the use of the drugs for cancer patients.
In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add black box warnings to their product labels about its association with pre-existing kidney disease patients and the onset Nephrogenic Systemic Fibrosis. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents. NSF is a devastating condition characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin, pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and even possibly death. There is currently no cure for NSF, but those who have received kidney transplants have shown improvement. On February 29, the U.S. Judicial Panel on Multidistrict Litigation designated the U.S. District Court for the Northern District of Ohio as the venue for any lawsuits that have been filed or will be filed in against the makers of gadolinium contrast dyes. An estimated 68 cases have been filed in more than a dozen different federal districts against gadolinium contrast dye manufacturers. The U.S. Judicial Panel indicated that the Northern District of Ohio provides a relatively central forum for the consolidation of this nationwide litigation.
A class-action lawsuit has been filed on behalf of a Philadelphia resident and patient with pre-existing kidney disease against the makers of a Gadolinium contrasting MRI agent. Zbigniew Marcinczyk contracted Nephrogenic Systemic Fibrosis after being injected twice with the contrasting dye Omniscan, manufactured by General Electric Company, before being administered an MRI. The two hospitals he received the injections at both confirmed the use of Omniscan. Shortly after the administration of Omniscan, Marcinczyk developed and continues to suffer from the severe, debilitating and progressive changes associated with NSF that has permanently disabled, disfigured and severely impaired him. The lawsuit further alleges that Omniscan is defective, that the manufacturers failed to adequately test Omniscan and failed to warn patients about its potential to cause NSF.
Bisphosphonates is a family of drugs used in treating osteoporosis. They include the name brands Fosamax, Didronel, Boniva, Aredia, Actonel Skelid Reclast and Zometa. In a publication sent to The New England Journal of Medicine the question was raised about an association between atrial fibrillation and the use of bisphosphonates. The article revealed information describing increased rates of serious atrial fibrillation which is life-threatening and can result in hospitalization or disability. In two different studies using older women with osteoporosis treated with the bisphosphonates they found an increase in the occurrence of atrial fibrillation when using the drugs as opposed to a placebo. The FDA is currently reviewing the safety of the drugs and will communicate their findings and recommendations in the coming months.
In a study conducted by researchers at the University of Michigan Health Systems, Jonathan R. Dillman, MD, lead author reports on allergic type reactions patients are experiencing when being administered gadolinium. Gadolinium has been linked to the debilitating and sometimes terminal disease Nephrogenic Systemic Fibrosis. The study reports that even when patients have been given corticosteroids and antihistamines before injected with gadolinium, some can still present with allergic-like reactions. For the study, researchers reviewed data from the institution’s department of radiology over a five-year period. They found that eight patients experienced nine allergic-like reactions after being gadolinium despite being pre-medicated. Out of these reactions, six were mild and three were moderate. There were no severe reactions. In response to the findings Dr. Dillman says, “Radiologists, therefore, must be available to treat an allergic-like reaction following gadolinium-containing contrast material administration.”
In a study appearing in the Journal of the American Medical Association it was found that treating cancer patients with anemia drugs increases their risk of blood clots and death. Anemia is a common complication of cancer treatment. The researches said the drugs, including Amgen Inc’s Aranesp and Johnson & Johnson’s Procrit, increased the risk of death by 10 percent. “Our findings, in conjunction with basic science studies, raise the concern that the drug may be stimulating cancer and shortening cancer patients' survival,” Dr. Charles Bennett of Northwestern University in Chicago said in a statement. He added, “The findings of mortality are new and are different from prior reports,” and said the drugs, erythropoiesis-stimulating agents (ESAs), also increased the risk of blood clots in the lungs and legs by 57 percent in cancer patients. An advisory panel to the U.S. Food and Drug Administration will be discussing safety concerns about the drugs on March 13. Last March, the FDA warned of an increased risk of serious and life-threatening side effects in a public health advisory on ESAs.
In November 2007 the FDA requested the drug Trasylol manufactured by Bayer AG be withdrawn because of concerns raised by an observational study linking the medicine to kidney failure requiring dialysis and increased instances of death. Trasylol is used in open heart surgery to stem bleeding. The results were reported on CBS Television’s 60 Minutes program. Dr. Dennis Mangano, the study’s researcher, said that upwards of 22,000 lives could have been saved if it had been taken off the market when he first published his study in January 2006. He feels that Bayer failed to disclose to the FDA in September 2006 that it had confirmed the same dangers as Dr. Mangano’s study. Bayer spokeswoman Meredith Fischer says they are facing a number of product-liability lawsuits concerning Trasylol filed by patients or their families, but did not disclose how many.
Joining the Duragesic transdermal Fentanyl patch recall is the company Actavis Inc. They announced that 14 lots of their generic version Fentanyl CII sold in the United States by subsidiary Actavis South Atlantic LLC are being voluntarily recalled from wholesalers and pharmacies. The recalled patches were manufactured by the contract manufacturer Corium International Inc. The 14 lots of the Fentanyl patch system may have a fold-over defect that can cause the patch to leak and expose patients and caregivers to the internal gel that could lead to serious side-effects such as respiratory depression and fatal overdose. Fentanyl is a potent Schedule II opiod medication. Anyone who comes in contact with the defective patches should rinse the exposed area thoroughly without the use of soap.
Denver Channel 7 News reported recently on the little known disease Nephrogenic Systemic Fibrosis. In an interview attorney Peter Burg informed the news station that the medical profession believes the disease is caused by a contrasting dye used in Magnetic Resonance Imaging (MRI) procedures on people with kidney disease. "It is the most awful disease that I have ever seen in my life," said Burg, who is representing close to 100 clients who are suing the manufacturers of gadolinium. "And what makes it doubly awful is that it was manmade." Greta Carolus of Loveland, Colorado is one of his clients. In August 2006 while preparing for a kidney transplant, Carolus underwent an MRI using the contrasting dye, gadolinium. Gadolinium is used to improve the quality of the picture in an MRI. Four days later she was hospitalized and learned she had contracted NSF. The lesions and hardening of her skin was caused by gadolinium exposure and put Carolus in a wheelchair. "I am a registered nurse, but I have not worked since the day this happened," said Carolus. "I wouldn’t wish this on anybody; my worst enemy I wouldn’t wish it on. This is just a terrible disease." In people with healthy kidneys, gadolinium has been proven safe. It is believed that the chemicals surrounding the gadolinium make it safe for use in the human body, but sometimes breakdown. In patients with ill-functioning kidneys, the gadolinium cannot be expelled properly thus exposing the patients to the dye for an extended period of time. “When I found out it was the dye it was devastating because it was something that didn't need to happen,” said Carolus. According to Carolus’ attorney, Peter Burg, the 5 companies that manufacture gadolinium contrast knew they were toxic to patients with kidney insufficiency. “They knew how toxic it was, they may not have known the specific harm that was going to be caused but they knew the results were likely to be catastrophic,” said Burg.
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The FDA has announced a recall of a transdermal patch system, which contains the prescription painkiller Fentanyl. The patches are sold in the U.S. under the names, Duragesic by PriCara and a generic version by Sandoz Inc. In Canada, the recalled patches are sold under the Duragesic brand by Janssen-Ortho Inc. and generically by Ranbaxy Laboratories Ltd. The recall includes all 25-microgram-per-hour patches with expiration dates on or before December 2009. It has been discovered that some of the patches may have a cut in the lining of the internal reservoir where the drug is held in gel form. Fentanyl is a powerful “opiod” drug and if it leaks into the drug’s packaging, releasing into the skin it could cause difficulty breathing and a potentially fatal overdose. If skin has been exposed to an increased amount of the gel due to a cut in the reservoir the area should be thoroughly rinsed, but do not wash with soap.
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It has recently been discovered that the recalled pre-filled Heparin syringes made by Baxter International blamed for causing allergic reactions and four deaths, was manufactured in a Chinese facility that was never inspected by the Food and Drug Administration. Both Baxter and the FDA claim it is not clear whether the product from the Chinese supplier is tied to the allergic reactions and deaths to the blood thinning drug. Baxter said February 11th that it was temporarily suspending production of Heparin because of approximately 350 negative reactions that may be a result of the drug. The allergic reactions have been mostly among patients undergoing kidney dialysis and heart surgery.
The Food and Drug Administration is notifying consumers about Icy Hot Heat Therapy products that have been voluntary recalled nationwide by makers Chattem Inc. This recall includes Icy Hot Heat Therapy Air Activitated Heat and the single use samples included in a limited promotion of its 3oz. Aspercreme® Pain Relieving Crème. Chattem is recalling these products because consumers have reported first, second and third degree burns as well as skin irritation resulting from consumer use.
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George Lipscomb of West Virginia and his wife Ruth Ann have filed a medical malpractice lawsuit against Bayer Corporation and Bayer Healthcare Pharmaceuticals after he contracted Nephrogenic Systemic Fibrosis following MRIs that used a gadolinium containing contrast agent. According to the suit, George Lipscomb received five MRIs from May 2, 2005 to May 29, 2007. NSF causes muscle weakness and inhibits flexing and extending of joints resulting in contractures. It can also progress enough to cause total loss of use in arms, legs, hands and feet. Lipscomb claims he was suffering from chronic renal insufficiency at the time of the first MRI. He was later diagnosed with NSF on Sept. 25, 2007. The lawsuit claims that Lipscomb did not know or have reason to know that his insufficient renal condition would cause him to be harmed by the contrasting agent and as a result, he developed excruciating pain in his leg, hip and foot. He is also experiencing tightening, swelling and stiffening of his skin, muscles and joints, has had difficulty walking and is in jeopardy of having his heart and lungs impaired. The Lipscombs feel Bayer was irresponsible toward the safety and health of those receiving the contrast solution. They seek compensatory and punitive damages. Attorney Barry Hill is representing the Lipscombs.
The Food and Drug Administration has linked botulism in some users to the anti-wrinkle drugs Botox Cosmetic and competitor Myobloc. Some cases have been so severe that a few children given the drugs for muscle spasms have died. In rare cases, the toxin can spread to other parts of the body, paralyzing or weakening the muscles used for breathing and swallowing, a potentially fatal side effect. Botox is best known for minimizing wrinkles by paralyzing facial muscles, but botulinum toxin is also widely used for a variety of muscle-spasm conditions, such as cervical dystonia or severe neck spasms. The FDA said the deaths it is investigating so far all involve children, mostly cerebral palsy patients being treated for spasticity in their legs. The FDA has never formally approved that use for the drugs, but some other countries have. However, the FDA warned that it also is looking into reports of illnesses in people of all ages who used the drugs, including at least one hospitalization of a woman given Botox for forehead wrinkles. The FDA wouldn't say exactly how many reports it is researching.
Zyprexa is a medication approved to treat people with schizophrenia and severe bipolar disorder and has been known to cause serious side effects. Eli Lilly, makers of Zyprexa has been under investigation for its marketing practices since 2004. In late 2000, Lilly began a marketing campaign called Viva Zyprexa and told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia. Internal documents and company emails have shown that Eli Lilly was planning to encourage doctors to prescribe Zyprexa for people with age-related dementia and mild bipolar disorder. Articles published in the New York Times in December 2006 describe Lilly’s multiyear effort to play down Zyprexa’s side effects and to promote the drug for other conditions. This practice is known as off-label marketing. Currently, federal prosecutors are discussing settling a civil and criminal investigation into the company’s marketing of the antipsychotic drug that could cost them $1 billion to be paid to federal and state governments. Lilly has already paid $1.2 billion to settle 30,000 lawsuits from people who claim that Zyprexa caused them to contract diabetes and other diseases. Zyprexa can cause severe weight gain and has been linked to diabetes by the American Diabetes Association. The Justice Department lawyers in Washington pressed for a grand jury investigation to examine whether Lilly should be charged criminally for its promotional activities.
Health Canada is reviewing the latest study on the Ortho Evra Transdermal birth control patch, marketed as Evra in Canada, to determine whether to issue any new warnings or label changes to the product. The U.S. Food and Drug Administration announced that the transdermal birth-control patch will carry an updated label warning women about the potential risks, the second time a warning has been issued for the product. It's the latest chapter in the controversial history of the birth-control patch and comes in the wake of reports from Health Canada that two women died and numerous others suffered serious medical problems after using the Evra product. Evra has been available in Canada since 2004. The latest finding seems to confirm fears about the patch and should send a strong message to women that they could be exposed to a potential health threat, said Anne Rochon Ford, co-ordinator of Women and Health Protection, a national advocacy group. “There were a lot of alarm bells going off for us from the beginning with this patch,” she said. “Contraception is used, by and large, by a healthy population and so the bar for its safety should be higher.” Health Canada has received 17 reports since 2004 of women who suffered blood clots and other serious problems after using the patch. The reports included one woman who died of a heart attack and another from blood clots in her lungs.
In response to the latest study coming out of the Boston Collaborative Drug Surveillance Program (BCDSP) the FDA is urging women who are currently using the Ortho Evra transdermal birth control patch to discuss with their doctors as soon as possible their risk to Venous Thromboembolism. Venous Thromboembolism or VTE is characterized by serious blood clots in a vein. At the sight of the clot, typically it will become painful, red and swollen and could partially or totally block blood flow. VTE occurs most often in the veins of the legs and pelvis and also the arms. If the clot or part of it breaks off and travels to the lungs and/or heart it is called a pulmonary embolism. Janet Woodcock, M.D., Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer, and acting director of the Center for Drug Evaluation and Research, said "For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved. This is an example of FDA working in tandem with the drug manufacturer to keep the public informed of new safety data and epidemiological studies that may impact health decisions about the use of FDA approved products."
A study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson has led the Food and Drug Administration to approve of label changes to the Ortho Evra Birth Control Patch. The label changes include findings of the epidemiology study that found users of the patch were at a higher risk of developing blood clots know as venous thromboembolism (VTE) than were users of birth control pills. VTE has been known to lead to pulmonary embolism. The recent study used women aged 15-44 and supports an earlier report that agreed with the findings. The FDA still believes that Ortho Evra is safe when used following the labels instructions. In September 2006, the FDA revised the label for Ortho Evra to warn women of the risk of VTE based on two epidemiology studies. The original BCDSP study showed there was not an increased risk compared to women using birth control pills. In contrast, a study conducted by i3 Ingenix, showed that some women using the patch were at twice the risk of developing VTE. It is interesting the variation of the findings by BCDSP between the study in 2006 and the most recent one.
In the most recent version of The New England Journal of Medicine a report was made on the lack of antidepressant drug studies being published. Almost a third of the studies are never scene in medical literature and it is attributed to the drug being tested did not work. In fact in some of the published studies, unfavorable results have been reworked to make the medicine appear more effective than it really is, said the research team led by Erick Turner of the Oregon Health & Science University. The studies authors continue, “Selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health.” A little known notion is that unfavorable test results are quietly tucked away and it’s called the “file drawer effect.” The Turner team used a U.S. Food and Drug Administration registry in which companies are supposed to log details of their drug tests before the experiments are begun. Of the 74 studies that started for the 12 antidepressants, 38 produced positive results for the drug. All but one of those studies was published. In contrast, only three of the 36 studies with negative or questionable results, as assessed by the FDA, were published and another 11 were written as if the drug had worked. "Not only were positive results more likely to be published, but studies that were not positive, in our opinion, were often published in a way that conveyed a positive outcome," said the authors.
A lawsuit has been filed in the Circuit Court of the City of St. Louis in Missouri on behalf of a woman who alleges she developed nephrogenic systemic fibrosis after being exposed to the contrast dye gadolinium. She was given OptiMARK® during an MRI scan and sustained the devastating and potentially deadly tissue disease, NSF. The complaint has been filed against Tyco Healthcare Group, LP and Mallinckrodt, Inc., (subsidiary of Tyco). The complaint states that as a result of being administered OptiMARK® by her physician three times during October 2004 and once during December 2004, the plaintiff was also overexposed to gadolinium. In July 2007, the plaintiff was diagnosed with NSF. Since then, her condition has resulted in bodily impairment, disfigurement, and scarring, as well as fibrosis and contractures in her extremities. NSF/NFD only occurs in patients with kidney disease who undergo an MRI or MRA where a gadolinium-based dye is used. Its symptoms include the skin’s texture changing to a wood-like consistency or feeling like orange peel. Accompanying these symptoms are sensations of burning, itching, and severe sharp pains in specific areas. The lawsuit also claims that Tyco Healthcare insufficiently tested OptiMARK® and disregarded the fact that it could cause debilitating and potentially lethal side effects. Furthermore, the suit states that Tyco Healthcare knew of the risk for dangerous side effects, yet withheld evidence from the Food and Drug Administration during the approval process. The number assigned to the case is Case No. 0722CC09411.
West Virginia University and Marshall University medical programs will benefit from a settlement of a class-action lawsuit filed against the makers of the diabetes drug Rezulin. After eight years of litigation the makers of the drug, Warner-Lambert Company and Parke Davis, decided to settle to avoid further costs. The class-action lawsuit was approved by the West Virginia State Supreme Court in 2003. Cases involving the most severe injuries and deaths had already settled their lawsuits. As part of the settlement, the defendants denied wrongdoing and yet the company withdrew the drug from the market. Supreme Court Judge Hutchison said an estimated 4,000 people could claim either a $200 or $1,500 payment if they file the required paperwork by February 4th. What is left will be sent to the two medical schools. West Virginia University will receive 63 percent of the funds and will be used for diabetes research. Marshall University will receive the rest for its rural health program and to establish a professorship with a specialty in diabetes. Hutchison said, “This has the potential for doing a world of good for people in West Virginia who are fighting this horrible disease. It's money that can lead to some breakthroughs or some more education to help people deal with their disease.”
On Monday January 7th, the FDA warned healthcare providers of complications arising from the use of bisphosphonates. They are marketed under the names, Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid and Zometa. The FDA wanted to make sure healthcare professionals were aware of any patients who may be suffering with severe pain in their bones, joints or muscles who are currently using these bisphosphonates. The healthcare industry is already informed of the relation between musculoskeletal (muscular) pain and the use of bisphosphonates, but may be overlooking the severe sometimes incapacitating pain and thus delaying diagnosis and treatment. To further complicate matters, when treatment with bisphosphonates begin, the initial side effects can be fever, chills, bone pain, myalgia and arthralgias, but typically resolves itself within several days of the initial intravenous treatment (and may occur with the once a week or monthly treatments). The difference between the beginning treatment and later treatments is that the future pain can become severe and debilitating. The later pain may occur within days, months or years after starting treatment. Some patients who discontinued use have reported complete relief, but others have reported slow or incomplete relief. The FDA advised the healthcare providers to consider whether bisphosphonates might be responsible for the severe pain their patients are currently experiencing and should consider temporary or permanent discontinuation of use.
The consumer group Public Citizen is suing the Food and Drug Administration charging the agency with ignoring calls for stronger warnings on the antibiotic Cipro and similar antibiotics that may cause serious tendon injuries. The fluoroquinolone family of antibiotics including Cipro and Levaquin, already have warnings about the rupture of tendons and other tendon injuries, but at the bottom of the list of side effects. Public Citizen wants those warnings updated to a black box warning, the strictest type of warning in addition to patients receiving pamphlets with each prescription describing the risk. The original petition was filed in August 2006. At the time the FDA’s database showed 262 reports of tendon ruptures between November 1997 and December 2005 in addition to hundreds of other tendon issues patients experienced. Public Citizen feels the FDA is violating its own statutes and putting patients at risk in taking so long to settle the issue.
A new study out of the University of Georgia finds that most prescription drug ads seen on television do not present all the information necessary to make an informed decision, especially when is comes to the risk of side effects. The team analyzed a week’s worth of consumer ads on broadcast and cable television. They found that the average 60-second ad contained less than 8 seconds of side effect disclaimers and 30-second ads had less than 4.4 seconds of disclaimers. “These ads clearly don’t devote enough time to information about risk,” said Wendy Macias, associate professor in the UGA Grady College of Journalism and Mass Communication. Her results appear in the November/December issue of the journal Health Communication. “Adding to the problem is that the information is often presented in a way that people aren’t likely to comprehend or even pay attention to,” she continues. The 1997 FDA guidelines that allowed drug companies to expand their direct-to-consumer advertising required the companies to “present a fair balance between information about effectiveness and information about risk.” Fair balance is not defined by the FDA. “Very few advertisers are really doing well enough when it comes to actually trying to educate the consumer,” she said. “The ads are presented in such a way that the consumer would have to be paying very close attention and be adept at processing the information to really understand the risks as well as the benefits.”
When the Ohio Supreme Court upheld a state law limiting how much a person injured by a defective product can be awarded for pain and suffering, the plaintiff’s attorney Janet Abaray had this to say, “The court has decided it is more important to protect a New Jersey company that came into Ohio and injured Ohio citizens than it is to protect Ohio citizens. We feel it’s a really tragic day in Ohio history.” Her statements were based off the law’s authors who said the decision would help improve Ohio’s reputation as a pro-business state. The truth is that the Ohio Supreme Court ruling will make it harder for ordinary Ohio citizens to hold big business accountable. Janet Abaray is representing Melisa Arbino who sued the New-Jersey based Johnson & Johnson over complications she suffered while using the Ortho Evra birth control patch. Arbino said Johnson & Johnson's didn't properly inform women that the patch has 60 percent more estrogen than birth-control pills. Her use of the patch resulted in her developing blood clots on her brain and lungs almost killing her. Arbino sued in Ohio but, because of an Ohio law change in 2004, she can't collect more than $350,000 for pain and suffering if she wins. Abaray challenged the law change in court, saying a jury - not Ohio lawmakers - should determine how much someone should be awarded for pain and suffering and that the law that caps the monetary damages violates Ohio's law allowing a jury to hear the case. The case is set for a June trial.
In a response to a closely watched federal lawsuit stemming from the Ortho Evra birth control patch, the Ohio Supreme Court upheld a 2004 law capping damages for pain, suffering and other non-economic claims in personal injury cases. This particular case involves Melisa Arbino who suffered a series of potentially fatal blood clots in her brain and lungs in 2005. Arbino maintains the clots were the result of her use of the Ortho Evra birth control patch. She is one of the fortunate ones. There have been a number of deaths in young woman who have used the patch. Ortho Evra is still being prescribed, but its label has been modified to inform users of the potentially serious side effects. Fortunately, the law does not limit damages in catastrophic cases involving paralysis or loss of limb and also does not limit economic damages. The Supreme Court decision does not bode well for victims of Johnson & Johnson’s irresponsible choice to withhold valuable and informative research studies on the effects of the Ortho Evra patch and its users.
LegalView.com recently updated its Web portal concerning new risks associated with the use of Avandia in Type II diabetes patients. In a recent study out of the Salk Institue for Biological Studies in La Jolla, California has found that long term use of Avandia, also known as rosiglitazone, causes an increase in bone fractures and breaks among patients who use it. Tests showed that the drug increased bone degradation cell activity. GlaxoSmithKline, makers of Avandia, acknowledge the increased risk of bone fractures and breaks among patients taking the drug, especially in older women, but the company did little to make users aware of this increased risk. LegalView.com remains the premiere site for legal information and its many legal information portals are used to serve people suffering from preventable diseases, illness and unfortunate accidents.
In Illinois a St. Clair County woman has filed suit against Ortho-McNeil Pharmaceutical claiming her use of their popular Ortho- Evra transdermal birth control patch caused her to develop deep vein thrombosis. Connie and husband Larry Lager filed the product liability suit October 17th against Ortho-McNeil Pharmaceutical, Johnson &Johnson and their Pharmaceutical Research and Development group. They claim the defendants relied on safety and risk information from previous studies done against contraceptive pills, thus not being further and sufficiently tested in clinical trials. The Lagers’ team of lawyers filed the compliant stating, “Defendants knew or should have known that the intake of hormones contained in Ortho Evra through the Patch would result in a level or estrogen...much higher (approximately 60% higher) than the levels associated with intake through the oral route, such as with birth control pills.” Additionally, the Lagers claim the defendants failed to take into consideration warnings from the Food and Drug Administration which determined that blood clots could be a problem with the patch.
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Johnson & Johnson settled a lawsuit in an agreement to pay $1.25 million dollars to the survivors of Alycia Brown, a victim of two blood clots in her lungs due to the use of the Ortho Evra transdermal birth control patch. Her lawyer, Janet Abaray, could not further elucidate because of a confidentiality agreement. Alycia used the patch for several weeks prior to the appearance of the blood clots in May of 2004. 5 million women are thought to be using the patch of which 2400 are filing or have filed lawsuits against Johnson & Johnson claiming strokes or clots in their legs or lungs. The company has already settled dozens of cases before trial. The Brown agreement highlights how much J&J is willing to pay to possibly avoid shedding light on the company’s safety concerns about the patch before market release in 2001. Details of the Brown agreement were found in a file of a lawsuit by the family of Zakiya Kennedy, who was 18 when she died on April 2, 2004, after using the patch. Court records show that a confidential settlement was reached in that case on Oct. 11. Another trial is scheduled for trial in St. Louis which involves the death of Ashley Lewis, who was 17 when she died in late 2003 after using the patch.
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After the recent controversies facing the makers of Avandia and the risk of heart failure, a new issue has emerged with the popular drug. According to the online issue of Nature Medicine, researchers found that the drug increased the degradation of bone in mice. This could explain why diabetics taking Avandia long term have had an increased risk of fractures due in large part to drug induced osteoporosis. GlaxoSmithKline, Avandia’s makers, has acknowledged that a study found a higher risk of fractures among woman taking the drug for diabetes. In the past the assumption was that the fragility of bones in diabetics was the result of naturally reduced bone-building activity and not increased bone removal. The finding “has led to a better understanding of the challenges associated with long-term treatment of patients with Type II diabetes,” said Ronald M. Evans of the Salk Institute for Biological Studies in La Jolla, Calif., lead author of the report. He goes on to say that the discovery was fortuitous. “Considering the widespread use of these drugs and the known action in people it is surprising that such a key observation had been missed,” Evans said. The research was funded by the Howard Hughes Medical Institute and the National Institutes of Health.
In the case In re Ortho Evra Products Liability Litigation, MDL 1742, in the U.S. District Court, North District of Ohio (Toledo) internal Johnson & Johnson documents have been made public that show that J&J, “withheld and altered data from the clinical trials which proved that the patch delivered significantly higher levels of estrogen than oral contraceptives. Obviously unaware of the withheld information, the FDA approved Ortho Evra for marketing” according to the motion filed Ortho Evra users Nov. 20 in federal court. Further, pre-trial interviews with Johnson & Johnson scientists show the company knew of the risk in 1999 and still misled the FDA when they were seeking approval in 2001. This new information was previously kept from the public’s knowledge when a judge considered it confidential. The documents being made confidential gave J&J the perfect opportunity to settle out of court in all previous lawsuits. Of course J&J disagrees and a spokeswoman said of the new filing it, “Takes out of context a few documents produced by the defendants in the course of this litigation to create a misleading and unfair presentation. The proper forum for these documents is the courtroom where, looked at in context, the evidence will show that Ortho Evra is safe and effective.” Janet Abaray, the Cincinnati attorney for seven women, declined to comment.
Lawyers are asking a federal judge to order Merck & Co. to develop and provide a program to monitor users of Fosamax, the osteoporosis drug linked to osteonecrosis. Osteonecrosis of the jaw is a condition where a portion of the jaw bone dies and sometimes leaves the bone exposed. A lawyer for the plaintiffs said hundreds of thousands would benefit from such a program which would include regular dental screenings, X-rays and lab tests. The lawyers made the suggestion to U.S. District Judge John F. Keenan as they argued for the case to be certified as a class-action. The Merck attorney believes there is no proven link between degeneration of the jaw bone and patients who use Fosamax. The plaintiffs’ attorney said as many as one in every 296 patients develop severe damage to the jaw, further arguing that a class-action certification would allow for a trial in which a jury would decide whether Fosamax is dangerous and if Merck was negligent when they did not inform the users of the danger. The Superior Court judge has yet to rule after hearing the arguments.
Janet Abaray, a Cincinnati attorney for seven women chosen as precursor plaintiffs, filed a motion Nov. 20th in Toledo, Ohio federal court stating that the makers of the birth control patch Ortho Evra misled doctors and regulators by altering and withholding medical data concerning the health risks associated with use of the patch. The seven plaintiffs are all from Ohio and include Sienna Tomko who when 14 suffered deep vein thrombosis in 2005 and Robert Douglas Rosfeld who lost his 25 year-old wife Stephanie to a heart attach after using the patch for only a month.
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Canadian resident George Dellefountaine is part of a class action lawsuit against the makers of OxyContin, a powerful painkiller. Dellefountaine was in a car crash in 2004 and was experiencing chronic pain. On his doctor’s orders he took the painkiller and ended up addicted. He has since stopped using OxyContin, but still experiences shakes, mood swings and other signs of addiction. Dellefountaine is one of 100 Atlantic Canadians who have decided to file suit against the maker of OxyContin, Purdu Pharma.
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An Altoona, PA woman has joined hundreds of others across the country in filing a lawsuit against the pharmaceutical company Ortho McNeil for marketing the Ortho Evra birth control patch which is linked to serious side effects. The patch has caused blood clots, heart attacks, strokes and death in women nationwide. Attorney Howard L. Nations filed the lawsuit on behalf of Helen Chandler Faretta in the U.S. District Court in Johnstown. The case will be transferred to the federal district court in Toledo, Ohio, where all of the Ortho Evra cases are being heard. The product remains on the market with FDA approval because the company has attached a warning label about the possible side effects of using Ortho Evra. Worldwide, the FDA-equivalent agencies in Canada, Great Britain and Japan have refused to allow the drug on the market because of its high output of estrogen. The pharmaceutical company altered the product in those nations to make them safe, but the FDA only requires a warning label. According to the lawsuit, Faretta was prescribed the product from July through August 2004. On Aug. 27, 2004, she experienced severe leg pain and was diagnosed with a blood clot in the leg and was immediately taken off the patch. Her attorney is seeking damages on nine counts, including a charge that the company violated Pennsylvania’s Unfair Trade Practices and Consumer Protection Act. Nationwide only a few of the lawsuits have been settled so far, including one involving a death.
Nine residents from Illinois, Wisconsin, Kansas and New York have filed suit against the manufacturer of the birth control patch Ortho Evra and several pharmacies in St Clair County Circuit Court, Illinois. The suit alleges that Ortho Evra caused them pulmonary emboli, venous thromboembolism and other severe injuries. The pharmacies named in the suit are American Drug Stores, Osco Drug, Walgreens, B&D Pharmacy and Rite Aid. It further contends that Ortho-McNeil Pharmaceutical and Johnson & Johnson in negligence designed, developed, manufactured, tested, packaged, promoted, advertised, marketed and distributed the patch. The complaint states, “Defendants negligently and improperly failed to perform sufficient tests, if any, on women using and/or wearing the Patch during clinical trials, forcing Plaintiffs and their physicians, hospitals and the United States Food and Drug Administration to rely on safety information that applies to an oral contraceptive agent....” Further, the complaint states that defendants had a right to know that the patch administered a much higher level of hormone at a 60 percent level contrary to the 30 percent level when using the oral pill contraceptive. The suit was filed on November 1st and includes Johnson and Johnson Pharmaceutical Research and Development and R.W. Johnson Pharmaceutical Research Institute as well.
MSNBC recently reported the case of a woman who is suffering from the after affects of an MRI using a gadolinium contrasting agent. Gadolinium-based dyes are injected into a patient to highlight specific tissue types making them easy to differentiate from other tissues on an MRI. The MRIs can be administered without a contrasting agent, but they are considered to be significantly less useful. To complicate matters, gadolinium is the only contrasting agent approved for use in most MRIs.
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In one of the largest defective drug settlements ever, Merck & Co. will pay $4.85 billion to end thousands of state and federal lawsuits over its painkiller Vioxx. Merck officials estimated that if the deal is accepted it would end 45,000 to 50,000 personal injury lawsuits involving U.S. Vioxx users who suffered a heart attack or ischemic stroke. Merck’s executive vice president Kenneth Frazier said, “Without this settlement, the litigation might very well stretch on for years,” and called the agreement responsible and reasonable. The negotiating teams met more than 50 times in several states and spent hundreds of hours on the telephone over many months to come to an equitable deal. Merck stressed that the agreement is not a class action settlement and that it is not admitting fault. Analyst Steve Brozak of WBB Securities called Merck's handling of the litigation “a Harvard casebook study of how to deal with a problematic product.”
At the request of the U.S. and foreign health officials Bayer AG has stopped worldwide sales of its anti-bleeding drug Trasylol. A Canadian study suggests that the drug is linked to a 50 percent higher risk of death than other drugs in the same clinical trial. The Food and Drug Administration asked the company to stop selling the drug until it could review further results from the study. Trasylol is used to prevent excessive bleeding during heart bypass surgery. It is also known as Aprotinin and works by blocking enzymes that dissolve blood clots. It is designed to stem blood loss and enable patients receiving heart bypass surgery to avoid transfusions. The suspension of the drug may be temporary for some patients. The FDA said it was exploring with Bayer whether to make the drug available on a restricted basis for use by physicians in certain patients they believe could benefit from the drug. Bayer estimates Trasylol has been used in roughly 4.8 million patients over the last 14 years. The Canadian study comparing Trasylol with two other drugs was halted when preliminary results suggested Trasylol exposed patients to a greater risk of death. The actual number of deaths was not available. The FDA said it requested the drug be pulled rather than wait the six weeks for further definitive results.
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LegalView.com is a complete online resource for anything legal and they recently re-launched their portal on the painful, debilitating and sometimes lethal disease Nephrogenic Systemic Fibrosis. Burg Simpson is a member and partner in this informative website on this disorder. The site can be found at http://nephrogenic-systemic-fibrosis.legalview.com. Visitors who would like to learn more about NSF and its related health issues are encouraged to visit this site. LegalView.com recognizes that NSF will be a public health problem for decades. The new website provides additional information on treatment resources and can help victims and their families find an attorney in their state.
Peter Gerber is suing several major pharmaceutical companies after contracting the incurable disease nephrogenic systemic fibrosis. The rare disorder is linked to dyes used in MRI scans for patients with kidney failure. The dyes contain a heavy metal known as gadolinium. The disorder is characterized by the stiffening of skin and joints thus restricting movement and has been know to lead to death in some cases because of possible affects on internal organs. No cures have been reported but some patients have seen improvement after treatment to improve their kidney function, according to the International Center for Nephrogenic Fibrosing Dermopathy Research. Mr. Gerber's suit claims that people with impaired kidney function are unable to properly eliminate the gadolinium from their system. Last year, the U.S. Food and Drug Administration issued an advisory that patients with moderate to end-stage kidney disease should avoid having medical scans that use gadolinium-based contrast dyes, such as magnetic resonance images and magnetic resonance angiographies. If the imaging is done, "prompt dialysis" following the procedure should be considered, the FDA said. Mr. Gerber had an MRI before he underwent a kidney transplant. The lawsuit filed in the San Francisco Superior Court names medical centers and the pharmaceutical companies known to develop the gadolinium contrasting dyes. After the advisory from the FDA, the companies put warnings on the gadolinium products.
Sanofi-Aventis, the maker of antibiotic Ketek, received a stern warning letter from the FDA which cited numerous serious violations in the drugmaker's safety study. Referring to the study known as "Study 3014," the FDA wrote, ". . . we conclude that Aventis did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations."
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http://www.burgsimpson.com/nsf.htmlNephrogenic systemic fibrosis (NSF), a new fibrotic skin disease was first recognized in 1997 in 15 patients receiving hemodialysis for kidney failure. The early reports noted that it closely resembled scleromyxedema, but was different enough for further study. People with end-stage renal disease (ESRD), account for 90% of the patients. Peritoneal dialysis appears to be associated with a greater risk for NSF compared to hemodialysis. The age range is from 8 years to 87 years old and does not discriminate against gender or race. Many countries have reported cases of NSF. NSF has been linked to gadolinium exposure which is contained in contrast agents used in MRIs. The initial observation that vascular surgery and thrombotic episodes were common before symptoms occurred prompted speculation that NSF may be triggered by an imaging contrast agent. The time it takes for symptoms to appear is anywhere from 2 to 75 days of which 25 days is the median. As NSF progresses, patients may experience significant decrease in the function of their hands and feet, with the development of joint contracting and stiffening. Some ultimately are confined to a wheelchair and need assistance with daily activities. Severe disability and even death mortality have been reported in patients with NSF. In May of this year the manufacturers of gadolinium contrast agents issued a “Dear Healthcare Professional” letter to inform them of the newly added “Black Box” warning added in the prescribing information for patients with renal failure.
The FDA has issued an alert to warn physicians about the hazards of drugs called "micro-bubble contrast agents" used to enhance ultrasound images for the diagnosis of heart problems. The main drug at issue is Definity, made by Bristol-Myers Squibb Co., but a second drug known as Optison by General Electric Co. is also expected to receive warnings.
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Sanofi-Aventis, the maker of antibiotic Ketek, received a stern warning letter from the FDA which cited numerous serious violations in the drugmaker's safety study. Referring to the study known as "Study 3014," the FDA wrote, ". . . we conclude that Aventis did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations."
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Andrew Flusche graduated with a J.D. from the University Of Virginia School Of Law. He works for American Life League as a public policy analyst and legal researcher. Here is an excerpt of a document he recently wrote:
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The FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes. An association between Byetta and acute pancreatitis is suspected in some of these cases. Amylin Pharmaceuticals, Inc., the maker of Byetta, has agreed to include information about acute pancreatitis in the "Precautions" section of the product label.
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Drug makers pulled cold medicines targeted for babies and toddlers off the market Oct 11th. The decision represented a pre-emptive strike by over-the-counter drug manufacturers prior to government advisers debate over the medicines' fate. It doesn't end concern about the safety of these drugs for children. The withdrawal includes medicines aimed at children under age 2. The Food and Drug Administration and other health groups reported deaths linked to the remedies in recent years, primarily from unintentional overdoses. A remaining question is whether children under 6 should ever take these nonprescription drugs. Baltimore city officials, the Maryland chapter of the American Academy of Pediatrics and prominent pediatricians around the country filed a petition with the FDA arguing that oral cough and cold medicines don't work in children so young and pose health risks not just for babies but for preschoolers, too. "Pediatricians are taught these products don't work and may not be safe. Yet almost every parent uses them," said Dr. Joshua Sharfstein, Baltimore's health commissioner and a pediatrician, who blames ads that over promise relief. The challenge will be to convince parents to try old-fashioned methods, like suctioning out infants' noses or using salt-water nose drops.
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An opinion piece written in the Washington Times opinion section claims that legislation to reauthorize the Prescription Drug User Fee Act signed last month could be a death sentence for patients with life-threatening illnesses who depend on new drugs making it to market quickly. All because of prescription drug safety provisions that could delay the approval of new medications. Lawmakers from both parties have accused the FDA of recklessly speeding drugs to market for the sake of corporate profits at the expense of patients in the wake of recent drug safety scares. That attitude prompted many of the changes in the new legislation. However, the authors write, studies conducted by FDA show the rate of drug withdrawals has remained essentially unchanged over the last 25 years, despite rising and falling approval times during that period. The health benefits of faster approval decisions far outweigh the risks associated with the small number of drugs that are eventually withdrawn.
The number of serious adverse drug events in the U.S. has more than doubled between 1998 and 2005, says a new study led by Thomas Moore of the Institute for Safe Medication Practices. The study results were published in the September 10 issue of the Archives of Internal Medicine.
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Facing a rising number of lawsuits filed over its Ortho Evra birth-control patch, Johnson & Johnson still and has always maintained that the patch is a “safe and needed” form of contraception. The hundreds of plaintiffs suing the pharmaceutical company feel otherwise, with most of them claiming that Johnson & Johnson had prior knowledge that the Ortho Evra patch had a higher risk of causing blood clots, stokes and heart attacks than oral contraceptives. Unfortunately for Johnson & Johnson, at least two former employees of the company have backed up those allegations. In 2005, the Food & Drug Administration (FDA) warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. Following key events in 2005 and 2006 prompted the FDA to request a change on the Ortho Evra label to i nclude
a stronger safety warning. Since then, the Ortho Evra patch has been the subject of more than 2500 lawsuits. The plaintiffs have ammunition to back up their claims. Two former employees at Johnson & Johnson had long ago expressed concerns that the company purposely chose to downplay the risks associated with the Ortho Evra patch. The revelations from the former employees are not good news for Johnson & Johnson. There is evidence that the company knew women using Ortho Evra were exposed to dangerously high levels of estrogen.
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Johnson & Johnson improperly claimed its Ortho Evra birth-control patch posed a low safety risk to women, a product-safety executive told Chief Executive Officer William Weldon in a 2005 letter, court records show. J&J faces lawsuits by more than 2,400 of the 5 million women who used the patch. Most claim they suffered strokes or clots in their legs or lungs. The company hasn't publicly identified reserves for the Ortho Evra litigation. The author of the letter investigated an “unusually high number” of blood clots caused by the patch and cited more than 20 reported deaths, according to the letter, made public on Aug. 25 by a New Jersey judge who oversaw some of the lawsuits. The executive, whose name was removed from the letter, said J&J conducted two studies and emphasized “partial and incomplete” results of the one that found the patch no riskier than birth control pills. The writer resigned because the company's conduct undermined his ability to evaluate product safety, t he let
ter said. The writer was a vice president who spent seven years at Johnson & Johnson, overseeing benefit and safety risk analysis in reproductive medicine and oncology, according to the letter.
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The numbers keep adding up for the Ortho Evra birth-control patch, but not in sales. They are down sharply, but the docket of product liability cases filed against Johnson & Johnson, the maker of Ortho Evra, is up. In its latest update, J&J said more than 2,400 Ortho Evra lawsuits have been filed in state and federal courts. Most of the lawsuits have a common theme: J&J allegedly knew the skin patch had greater safety risks than birth-control pills, particularly in the incidence of harmful blood clots that could develop in women's legs and lungs. Nevertheless, it chose to aggressively market the contraceptive in ads and played down the dangers of the patch.
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The Fiji Government Pharmacy says it does not import the birth control patch Ortho Evra because it is causing health complications for women in the United States. The pharmacy report comes in response to the filing of another lawsuit against the maker of the birth control patch in Washington. The lawsuit claims 43 women developed blood clots and other health problems since taking the prescription contraceptive. The Fiji Government pharmacist Waisea Kelo said the health ministry has never purchased the product nor issued them at its health centers and hospitals. A number of major drug wholesalers and chemists around Fiji confirm they have not imported nor sold the birth control patch. The international medical journal quoted lawyers in the US as saying the Ortho McNeil Pharmaceutical Company should pay substantial financial damages to their clients for the health problems suffered. According to the journal, similar lawsuits have been filed on behalf of 400 women nationwide but the company is not commenting.
Recently, PricewaterhouseCoopers (PwC) released the results of a survey of perceptions of the pharmaceutical industry titled, "Recapturing the Vision: Resoring Trust in the Pharmaceutical Industry by Translating Expectations into Actions." Among the interesting findings is this one:
The dangers of using skin patches to administer medicine are still not being heeded. In the wake of Ortho Evra deaths and disability, patches are still being prescribed. Army Master Sgt. Harold Kinamon entered a military hospital for routine respiratory surgery to help him sleep better. The operation went smoothly. He went home with little more than a raw throat and a painkiller contained in an adhesive patch on his skin. The particular painkiller he received, an opium-like drug called fentanyl, three months earlier had strong warnings issued against it by the Food and Drug Administration. This was in response to a number of similar deaths. At the time of Kinamon’s prescription the dangers were clearly understood. The night after surgery, Kinamon, 41, died in his sleep. He died by an overdose of the drug delivered through the patch.
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Shoulder arthroscopy is a rapidly expanding field, and arthroscopic shoulder procedures are increasing in frequency and popularity. Complications exist but are considered by the community to be relatively rare compared with open procedures. Severe glenohumeral chondrolysis is a severe, life-altering complication that has been seen following shoulder arthroscopy. Several theories as to the cause of this complication have been put forward, but none has been firmly identified. Treatment options are limited. The use of thermal devices has been implicated as a possible cause in most published cases.
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Schering-Plough Corp. faces federal court litigation over promotion of its drugs for uses not approved by the Food and Drug Administration. Eight putative class action suits are pending. The suits come in the wake of an August 2006 agreement by which the Kenilworth drug maker agreed to pay $435 million to settle criminal and civil charges over its drug-marketing practices. The government had alleged kickbacks to physicians and aggressive promotion of drugs for unapproved uses. The pending suits concern the drugs Intron, approved by the FDA for chronic hepatitis, AIDS-related Kaposi's Scarcoma, melanoma and lymphoma; Temodar, for certain brain tumors; Eulexin, for prostate cancer; PEG-Intron, for chronic hepatitis; Rebeton, for hepatitis C; Integrilin, for heart conditions; and Fareston, for breast cancer.
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