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

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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.

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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.”

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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

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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.

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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.

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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.

Posted by Kerry N. Jardine at 07:25 PM | Permalink | Comments (0) | TrackBacks (0)

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.

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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.

Posted by Kerry N. Jardine at 08:30 AM | Permalink | Comments (0) | TrackBacks (0)

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.

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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.”

Posted by Kerry N. Jardine at 01:33 PM | Permalink | Comments (0) | TrackBacks (0)

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.”

Posted by Kerry N. Jardine at 08:29 AM | Permalink | Comments (0) | TrackBacks (0)

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" »

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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" »

Posted by Kerry N. Jardine at 08:48 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:00 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 12:26 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 07:16 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 12:26 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 04:20 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 12:08 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 12:44 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Seth A. Katz at 12:32 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Seth A. Katz at 12:40 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Seth A. Katz at 08:38 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:35 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Seth A. Katz at 08:33 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:20 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:06 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Seth A. Katz at 08:04 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:30 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:28 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 02:28 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:21 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Peter W. Burg at 08:31 AM