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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In the June issue of the American Journal of Kidney Diseases, gadolinium-based contrasting agents used in MRIs was reported to increase the risk for Nephrogenic Systemic Fibrosis. It has been known for some months that there was a link between gadolinium exposure and NSF presenting itself in those with kidney failure. In fact, the U.S. Food and Drug Administration late 2007 issued a “black box”, the most severe warning, for any MRI contrasting products containing the agent. Dr. Alexander J. Kallen from the Centers for Disease Control and Prevention, Atlanta, and colleagues conducted a case-control study of 19 patients with NSF treated at a St. Louis hospital dialysis unit and 57 matched controls from the same unit. The authors reported that 14 patients with NSF had undergone an MRI with a gadolinium injection in the previous year that showed a median interval of 123 days from the gadolinium use in the MRI and the time the disease was detected. Four of the remaining five patients had gadolinium exposure between 16 and 68 months before diagnosis. The risk for NSF increased in steps from one MRI, two to three MRIs, or four or more MRIs, compared with controls. “Providers should carefully weigh both the benefits and potential harms of contrast MRI in their clinical decision making and avoid the use of gadolinium contrast agents if possible in patients with renal failure,” the authors concluded. “If gadolinium contrast is needed, clinicians should use the lowest possible dose and limit the number of future contrast administrations. The mechanism by which gadolinium contrast might cause NSF is unknown,” the researchers add.

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A lawsuit has been filed on behalf of a Minnesota woman who developed the debilitating and sometimes deadly disease, Nephrogenic Systemic Fibrosis. The woman contracted the disease following an injection of Magnevist Gadolinium contrasting dye manufactured by Bayer-Schering and its subsidiary Berlex Laboratories prior to an MRI (Magnetic Resonance Imaging). Nephrogenic Systemic Fibrosis is the consequence of gadolinium contrasting dye use in those with an impaired renal system such as kidney disease. Those with kidney dysfunction cannot eliminate the toxic dye as quickly and efficiently as those without, causing abhorrent side effects including the thickening and hardening of the skin, joint problems, deep pain in the ribs and hips leaving many wheelchair bound experiencing extreme pain. Death has also been known to occur once the disease reaches the internal organs. The woman received a gadolinium injection in March 2001 and in February 2007 was finally diagnosed with NSF by doctors at the Mayo Foundation. She continues to experience a progressive fibrotic debilitation causing severe impairment. Her lawsuit was filed with the Multidistrict Legislation, Northern District of Ohio alleging that Magnevist is defective and that the creators failed to adequately test and ultimately warn patients about its potential to cause NSF. In September 2007, the Food & Drug Administration (FDA) asked all manufacturers of gadolinium contrast dyes to add a “black box” warning to the product labels about its association with NSF in addition to warning patients with kidney disease who should avoid gadolinium contrast agents. Numerous cases have been filed in many federal districts against gadolinium contrast dye manufacturers. On February 29, 2008 the U.S. Judicial Panel on Multidistrict Litigation designated the U.S. District Court for the Northern District of Ohio as the venue for all the lawsuits that have been filed, and that will be filed in federal district court, against the makers of gadolinium contrast dyes.

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A new technology may be released soon that goes further to protect patients with renal failure while undergoing an MRI. Luna nanoWorks and the Washington University School of Medicine co-authored a paper that was published in the Journal of Medicinal Chemistry. The paper introduces a new avenue of gadolinium delivery that could protect patients with insufficient kidney elimination from the debilitating and sometimes deadly disease Nephrogenic Systemic Fibrosis after undergoing and MRI. The paper describes the new contrast agent as encapsulating the gadolinium metal within an extremely stable carbon nanosphere, thus allowing for extended existence in the body. Patients with kidney insufficiency eliminate toxins slower than those with normal renal function. Luna's HYDROCHALARONE™ molecules have initially proven to be more effective at enhancing images and are potentially safer than current gadolinium-containing contrast agents, which have been associated with Nephrogenic Systemic Fibrosis. Currently gadolinium contrast agents are formulated in a chelate to prevent toxicity, but the chelate agent is designed to be in the body for a short period of time. In those with renal failure their slow elimination process allows the gadolinium to separate from the chelate, thus exposing the patient to the toxic metal. The new delivery process of gadolinium may be a boon to those who need to undergo and MRI, but suffer from kidney failure. The U.S. Food and Drug Administration continues to review reports of patients who have developed NSF after receiving the chelate-based gadolinium agent. In response to reports of patient exposure, the FDA issued a black-box warning, the highest available, to warn the medical community of the possible consequences of using the chelate-based gadolinium in patients with renal insufficiency.

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Tennessee resident, Jeanie Deason, has won a two year battle in getting an experimental treatment approved for Nephrogenic Systemic Fibrosis (NSF) covered by TennCare, the state’s insurance plan for the poor and disabled. It's a ruling that a legal expert on health coverage says could potentially assist thousands of others with rare diseases across the country. Patients with rare disorders often face the same predicament as Deason. Insurance companies typically will not cover a treatment unless the FDA has approved it for that particular disease. In regards to NSF, there is no FDA approved treatment. During the two year battle Jeanie Deason’s condition worsened. Dr. John Zic, Deason's physician and an assistant professor of dermatology at Vanderbilt, has treated four of the 200 plus patients worldwide who have NSF. The treatment, extracorporeal photopheresis, involves removing blood from the patient’s body, exposing it to ultraviolet light and then re-infusing it back into the body. Dr. Zic has used the procedure in 3 out of four successful outcomes. One patient who was initially unable to close her hand could use a pen to sign documents after three months of treatment. Another patient had significant joint stiffness and difficulty walking, but nearly seven months later, was walking without a significant limp. The therapy will cost several thousand dollars per month. Deason will undergo two treatments a month for one to two years, according to Zic. It's something that Deason could never afford with the $695 in Social Security she collects each month.

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Patients with renal dysfunction or kidney failure need to be aware of side effects they could experience while undergoing an MRI after being administered Gadolinium. Gadolinium has been linked to the debilitating and potentially deadly disease Nephrogenic Systemic Fibrosis. NSF presents itself with symptoms of hard, shiny, darkened skin that tightens and becomes extremely painful, joint inflexibility, loss of movement, yellow-colored eyes, painful joints, and lung, heart and organ damage. Those who are at risk of NSF are unable to properly evacuate the gadolinium, thus causing the side effects. If a patient, who has undergone an MRI but does not know whether they have renal dysfunction, has presented with any of the symptoms they should immediately check their medical records to see if Gadolinium was administered. Late last year the U.S Food and Drug Administration warned doctors about the use of gadolinium based contrast agents in patients with renal failure and encouraged the doctors to screen all patients for kidney health if they are to undergo an MRI.

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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.

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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.

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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.

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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.”

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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.

Continue reading "Peter Burg interviewed by Denver News channel about NSF" »

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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.

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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.

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According to the American Journal of Roentgenology, published by the American Roentgen Ray Society, adverse allergic reactions to gadolinium are minimal in patients without renal failure. Their study is in response to the recent concerns associated with the disease Nephrogenic Systemic Fibrosis and the use of Gadolinium contrasting dyes. “Over the past few years, the utilization of contrast-enhanced MRI has markedly increased; it’s increased by 65% at our institution over the previous five years,” said Dr. Dillman. This is due in large part to a variety of new applications, such as magnetic resonance angiography (MRA) and abdominopelvic MR imaging,” he said. “Consequently, the number of intravenously administered gadolinium-containing contrast material doses over the same time period has significantly increased. Based on the extensive use these intravascular contrast agents, we felt that it was once again time to study their safety profile,” he said.

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Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD) is rare, but so far has only affected people with pre-existing kidney problems. The link between Gadolinium MRI dyes and NSF is gaining ground and quickly becoming irrefutable as the cause of the debilitating and sometimes deadly disease. In 2006, researchers discovered a direct association between NSF and the use of Gadolinium MRI contrast dyes. Since then, several other studies have reinforced the link between NSF and Gadolinium. The FDA in 2006 first warned doctors of the side effect. In 2007 the FDA ordered the manufactures of Gadolinium to add a black box warning, the strictest type of FDA warning, to their product labels advising of the risk of NSF to people with kidney problems. NSF leads to excessive formation of connective tissue in the skin and internal organs and is 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. Researchers at Yale University have reported that 95-percent of those with NSF had an MRI that involved Gadolinium two to three months before their symptoms appeared. Researchers at Massachusetts General Hospital also have found that kidney patients who had undergone MRIs with Gadolinium were 10 times more likely to develop NSF than patient who had not been exposed to such agents. Unfortunately, there are no effective treatments for NSF, although some patients have improved following a kidney transplant and there are no other alternatives to gadolinium based MRI contrast agents.

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Chinese agencies have become aware of complications associated with the use of gadolinium contrast agents used in MRIs. They are warning doctors of the link between gadolinium and the disease nephrogenic systemic fibrosis. The population at risk is those with serious kidney problems such as kidney failure. The kidneys of the people are incapable of eliminating the dye through normal body functions. Gadolinium attaches to specific tissue types highlighting them from other tissues so they can be viewed better by MRI technicians. What remains troublesome is that gadolinium is the only contrasting agent approved for use in most MRIs. The alternatives are Feridex I.V. and Teslascan, but they are limited in use for only examinations of specific liver problems. The NSF symptoms identified is the severe thickening of the skin leading to immobility and can affect the liver lungs and heart. NSF has been confirmed in children and the elderly, but tends to affect the middle-aged most commonly, according to the International Center for Nephrogenic Fibrosing Dermopathy Research. Men and women are affected equally.

Posted by Kerry N. Jardine at 06:21 PM | Permalink | Comments (0) | TrackBacks (0)

Luna Innovations Incorporated has been awarded a grant from the National Heart, Lung and Blood Institute to develop a new agent used in MRI. The carbon nano-material based contrast agent does not contain gadolinium, the dye linked to the devastating disease Nephrogenic Systemic Fibrosis. Although it is being developed at this time for the diagnosis of coronary artery disease (CAD), the expanded significance can assist in MRIs used on individuals with kidney failure and halt the risks of gadolinium exposure. Luna’s contrast agent is anticipated to give a physician not only improved diagnostics, but safety in the non-gadolinium product when exposing the dye to at risk individuals. The product, Trimetasphere® encloses the metallic signal molecule so that it cannot escape and cause harm to a patient. Through this mechanism the Trimetasphere®-based agent may help in preventing Nephrogenic Systemic Fibrosis. In May, the FDA issued a black box warning for the current gadolinium-based contrast agents used in MRI to increase awareness of the risks of NSF in patients with kidney problems.

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In a separate and new study researchers in Scotland have once again linked Gadolinium containing contrast agents used in MRIs to the devastating and sometimes deadly disorder nephrogenic systemic fibrosis. Their findings have added to the growing quantity of evidence that strongly associates the onset of NSF with people receiving MRIs who have pre-existing kidney disease. The Scottish study looked at 1,826 patients who underwent renal replacement therapy at two Glasgow hospitals between January 1, 2000 and July 1, 2006. Of those patients, 421 underwent an MRI that involved the use of a Gadolinium based contrast agent. Fourteen were diagnosed with NSF, and of those, 13 had been exposed to Gadolinium during an MRI. The researchers also found that the patients with NSF had received far higher doses of Gadolinium than those patients who were exposed to it but did not develop the disorder. The Scottish study was the second published this month that confirmed the link between NSF and Gadolinium. In their report they suggested that Gadolinium contrast agents be avoided altogether or at the very least in patients with pre-existing kidney issues. Also, in cases where Gadolinium is the only alternative the lowest dose possible should be used.

Posted by Kerry N. Jardine at 06:32 PM | Permalink | Comments (0) | TrackBacks (0)

In a separate and new study researchers in Scotland have once again linked Gadolinium containing contrast agents used in MRIs to the devastating and sometimes deadly disorder nephrogenic systemic fibrosis. Their findings have added to the growing quantity of evidence that strongly associates the onset of NSF with people receiving MRIs who have pre-existing kidney disease. The Scottish study looked at 1,826 patients who underwent renal replacement therapy at two Glasgow hospitals between January 1, 2000 and July 1, 2006. Of those patients, 421 underwent an MRI that involved the use of a Gadolinium based contrast agent. Fourteen were diagnosed with NSF, and of those, 13 had been exposed to Gadolinium during an MRI. The researchers also found that the patients with NSF had received far higher doses of Gadolinium than those patients who were exposed to it but did not develop the disorder. The Scottish study was the second published this month that confirmed the link between NSF and Gadolinium. In their report they suggested that Gadolinium contrast agents be avoided altogether or at the very least in patients with pre-existing kidney issues. Also, in cases where Gadolinium is the only alternative the lowest dose possible should be used.

Posted by Kerry N. Jardine at 06:32 PM | Permalink | Comments (0) | TrackBacks (0)

72-year-old Peter Gerber of San Rafael, Calif. has joined a growing collection of people suing several major health companies for causing him to suffer the painful, incurable and sometimes deadly disease, Nephrogenic Systemic Fibrosis. The gadolinium dyes used to scan his failing kidneys with MRI have been linked to the disease. Peter Gerber’s suit claims people with kidney failure cannot eliminate the gadolinium dyes from their system, ultimately causing them to develop NSF. Last year, the FDA issued an advisory that patients with moderate to end-stage kidney disease should avoid having medical scans that use gadolinium-based contrast dyes. If the imaging is done, “prompt dialysis” should be considered immediately following the procedure. Mr. Gerber had an MRI prior to undergoing a kidney transplant. His lawsuit, filed in San Francisco Superior Court, names medical centers and companies involved in making, distributing and using the dyes, including Bayer Healthcare Pharmaceuticals Inc. and GE Healthcare Inc. Both companies have since added “black box” warning labels to their dyes. “Mr. Gerber was never warned that there was any kind of risk associated with gadolinium, let alone NSF,” said Gerber's attorney. “Because of that, he developed a life-threatening disease that will most likely take his life in a horrible way.” He further indicates, “There is only one identified cause of NSF, and that's gadolinium and there is only one way gadolinium gets into the human body, and that's through these contrasting agents.”

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Bayer HealthCare Pharmaceuticals, in the midst of product safety issues concerning their MRI imaging contrasting agent Magnevist, announced that they have been awarded a three-year contract renewal by HealthTrust Purchasing Group to make the injection available to their HealthTrust network. Bayer holds more that 50 percent of the U.S. market share for gadolinium containing contrasting agents and has the broadest range of FDA approved usage than any other MRI agent for adult and pediatric patients. However, a cloud is over the company due to a link between their product and the debilitating, painful and sometimes deadly disease Nephrogenic Systemic Fibrosis. In fact, in their news release they initiate a warning to readers about who the agent should not be used on, such as those with acute renal insufficiency or perioperative liver transplantation. They further caution for all patients to undergo a screening for renal dysfunction as well as not to exceed the recommended dose and to allow a sufficient period of time for the agent to eliminate itself from the system. What they fail to elucidate is that there are other options available to technicians that do not use the sometimes toxic gadolinium. Toshiba recently announced its fourth generation contrast-free imaging technique known as Time and Space Angiography (TSA). TSA creates images that show dynamic blood flow without using contrast agents. In contrast, Bayer’s press release warns of possible serious and life threatening anaphylactic reactions, as well as cardiovascular and respiratory manifestations when using Magnevist. It makes one wonder what these health groups are thinking to allow their patients access to such a controversial treatment.

Posted by Kerry N. Jardine at 12:54 PM | Permalink | Comments (0) | TrackBacks (0)

LegalView.com announced that it will launch an informative and detailed Nephrogenic Systemic Fibrosis blog on its website to inform victims of further findings regarding this debilitating and often deadly disease. Nephrogenic Systemic Fibrosis has been linked to the use of Gadolinium, a chemical dye used in magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) tests. The blog offers resources, jury verdicts and information about attorneys for those who need help from a staff knowledgeable in the area of NSF

Posted by Kerry N. Jardine at 06:37 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Continue reading "MSNBC report of woman afflicted with NSF" »

Posted by Kerry N. Jardine at 09:40 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Continue reading "MSNBC report of woman afflicted with NSF" »

Posted by Kerry N. Jardine at 09:40 PM | Permalink | Comments (0) | TrackBacks (0)

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.

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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.

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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.

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A complaint has been filed in the San Francisco Superior Court against Bayer Corp., General Electric Co., McKesson Corp. and other companies involved in the manufacturing and distribution of the contrast agent gadolinium used in MRIs. In this circumstance however, the firm is taking a case by case approach rather than a federal multi-district litigation (MDL) one. The plaintiff is a man with kidney disease who had the agent injected prior to an MRI and contracted the incurable disease Nephrogenic System Fibrosis. The victims’ lawyer says his client doesn’t have the kind of time it would take to fight in the MDL process and in fact hopes to invoke a California rule that puts cases involving a severely ill plaintiff on a track faster than normal. Further saying, that if his client is able to stay alive for the next 10 years, his treatment for NSF can be upwards of $10M in medical expenses.

Posted by Kerry N. Jardine at 06:56 AM | Permalink | Comments (0) | TrackBacks (0)

Activation of transglutaminase-2 (TG2) may trigger the debilitating fibrosis that affects some end-stage renal patients, researchers believe. In a pilot study using stored tissue, an enzyme involved in wound healing was markedly increased in the skin of patients who suffered nephrogenic systemic fibrosis (NSF), according to David Sane, M.D., of Wake Forest University Baptist Medical Center, and colleagues. While the cause of Nephrogenic Systemic Fibrosis is officially unknown, research has shown that gadolinium accumulates in the tissues of people with the condition. It's also known that gadolinium activates a class of enzymes known as tissue transglutaminases.

Continue reading "Healing Enzyme Implicated in Nephrogenic Systemic Fibrosis" »

Posted by Kerry N. Jardine at 04:53 PM | Permalink | Comments (0) | TrackBacks (0)

General Electric Co., Bayer AG and two other companies have alerted doctors to new warnings about side effects of their chemicals which are used in imaging procedures. The letter dated Sept. 12 cautions that chemicals with gadolinium, which are used in magnetic resonance imaging procedures, can raise the risk of a sometimes fatal disease that causes excessive tissue to grow between internal organs. The new warning appears in a black box on the packaging for the chemicals, which are injected into the body to improve quality of images. The Food and Drug Administration requested the black box, which is the most serious type of warning a medical product can carry, in the spring. The language warns that patients with kidney failure are more likely to develop a very rare disease called nephrogenic systemic fibrosis when treated with the imaging chemicals. The other companies co-signing the letter were Italian firm, Bracco Diagnostics Inc. and St. Louis, Missouri-based Mallinckrodt Inc.

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The newly identified Nephrogenic Systemic Fibrosis (NSF) is the debilitating and painful condition that affects patients with kidney failure and is characterized by a thickening and hardening of the skin. It can progress so rapidly that patients can be immobilized and wheelchair-bound within a few weeks. The condition has been linked to gadolinium, a contrast agent used in MRI scans. A new study published in the October issue of Arthritis & Rheumatism on the prevalence of NSF and its risk factors found that the disease is associated with an increased risk of dying and that gadolinium exposure is the significant factor for developing it. The study was conducted on patients undergoing dialysis at six outpatient centers in the Boston area. They used a simple three-part skin examination to check for the three skin changes associated with NSF: hyperpigmentation (darkening of the skin), hardening and tethering (thickening). Patients with two out of the three findings were considered to have a positive examination for NSF and their death rates were followed for two years following the exam.

Continue reading "Higher death rates in kidney patients with NSF" »

Posted by Kerry N. Jardine at 10:49 AM | Permalink | Comments (0) | TrackBacks (0)

Researchers at Wake Forest University Baptist Medical Center, working with colleagues at other institutions have released findings of their research into why some patients who are in kidney failure also develop a condition known as nephrogenic systemic fibrosis (NSF). NSF has caused tightening and swelling in the skin and other organs, among them the lungs and the heart. They have known that 2 to 4% of patients on dialysis and injected with a contrast agent, gadolinium, prior to an MRI have developed the disease. While they know that the gadolinium causes the problem, until now, it has not been known how. This study suggests that an enzyme named transglutaminase-2, TG2, may play a part.

Continue reading "Research suggests cause and possible treatment of NSF " »

Posted by Kerry N. Jardine at 09:48 PM | Permalink | Comments (0) | TrackBacks (0)

Kidney disease patients with nephrogenic systemic fibrosis (NSF) are at increased risk of death, U.S. researchers report. The researchers also concluded that exposure to gadolinium during MRI scans are a significant risk factor for developing NSF. The disease can progress so rapidly that some patients are immobilized and confined to a wheelchair within weeks. The study, led by Jonathan Kay of Massachusetts General Hospital in Boston, conducted skin examination of 186 kidney dialysis patients. They found that 25 had skin changes consistent with NSF. Within two years, 25 of the 186 patients (24 percent) had died. The death rate for those with NSF was 48 percent, compared to 20 percent for patients without the illness. The researchers also found that 30 percent of patients exposed to gadolinium developed NSF compared to one percent of those who had not been exposed to the contrast agent. The findings are published in the October issue of the journal Arthritis & Rheumatism. This is the first study to examine the prevalence of NSF in dialysis patients and the first to quantify the association between NSF and gadolinium exposure. Contrast agents containing gadolinium should only be used with extreme caution in patients with chronic kidney disease, the researchers concluded. If they are exposed to gadolinium, these patients should subsequently receive regular skin examinations. In an accompanying editorial, experts at Yale University School of Medicine noted that a U.S. federal Public Health Advisory urges caution in the use of MRI scans for kidney disease patients and prompt dialysis for those who've had scans involving gadolinium.

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Gadolinium products used in MRIs will now carry th