Recent News
FDA Panel Backs Stronger NSF Warnings for Omniscan, Omniscan
Tougher labels warning of the risk of nephrogenic systemic fibrosis (NSF) could soon be on the way for some gadolinium contrast dyes. On December 8, 2009, a Food & Drug Administration (FDA) advisory panel agreed that General Electric's Omniscan, Covidien's Optimark and Bayer's Magnevist appeared to carry a greater risk of NSF.
According to Reuters, the panel recommended a tougher warning for both Omniscan and OptiMark that would contraindicate their use in people with severe kidney disease, but the panel could not reach a consensus on a similar warning for Magnevist. No actual vote was taken, but the recommendation represented the overall opinion of the panel.
The recommendation isn't too surprising. According to Dow Jones News Services, the FDA and health regulators in Europe have received hundreds of reports of patients with severe kidney disease who developed NSF after exposure to gadolinium contrast dyes. In November, Europe's health regulatory agency said Omniscan, Magnevist and Optimark shouldn't be used in patients with severe kidney problems.
The FDA and the manufacturers of gadolinium contrast dyes have been studying their link to NSF since a black box warning regarding the disease was mandated for the products' labels in 2007. In documents released in advance of the advisory panel meeting, FDA staff reached conclusions similar to the advisory panels'.
According to those documents, the highest risk of NSF was associated with Omniscan, Magnevist and Optimark. The lowest risk was associated with Bracco Diagnotics' Prohance and Multihance. However, the agency said ?the data do not appear to rule out an NSF risk for each of the agents.? FDA reviewers said the extent of risk from any of the agents was unknown. One study of Omniscan estimated the chance of developing NSF was 4 percent among patients with severe kidney impairment.
Though the FDA's drug safety unit said at that time that the risk associated with the gadolinium contrast dyes ?does not compel removal of specific (imaging agents) from the U.S. market?, it also recommended that the drug labels note the varying levels of risks with each product.
The FDA advisory panel did agree that the risk of NSF from gadolinium contrast dyes applied only to patients with severe kidney disease. Such problems affect less than 0.5 percent of the U.S. population.
During the advisory panel meeting, some members expressed concerns that labeling for gadolinium agents needed to reflect their real world use. Radiologists speaking at the meeting noted that gadolinium contrast dyes are, for the most part, no longer used in people with severe kidney disease.
The FDA will now make the final decision on any label changes, and will consider the input of the advisory panel. The agency does not have to follow recommendations of advisory panels, but it usually does so.
Last month, Covidien said it was already updating the OptiMark label to include a contraindication for people with severe kidney impairment. At the FDA advisory panel meeting, an official with General Electric maintained that the idea that some gadolinium agents were riskier than others remains unproven and advocated sticking with the current black box warning. But according to Reuters, the company later put out a statement that it would "actively cooperate with the FDA to determine the best path forward." Bayer also said it would work with the agency to address the NSF issue.
NSF Risk Among Gadolinium Agents Varies
In November 2009, the FDA said a review of gadolinium contrast dyes had concluded that Omniscan, OptiMARK and Magnevist carried a higher risk of NSF than others currently on the market. In documents posted on its Web site, the agency?s drug safety unit said the risk associated with the gadolinium contrast dyes ?does not compel removal of specific (imaging agents) from the U.S. market?, but it did recommend that the drug labels note the varying levels of risks with each product. An outside panel of experts was slated to take up the issue in December.
The maker of OptiMARK chose not to wait for the FDA panel to rule on label modifications. On November 17, 2009, the company issued a statement saying that OptiMARK's label would now contraindicate its use in patients with severe kidney impairment. The company said it was implementing the new label in the U.S. effective immediately.
Dying for an MRI - 7 News Investigation
Dying for an MRI - 7 News Investigation (WSVN 7 Fox News Miami/Fort Lauderdale)Parker Waichman Alonso LLP Files Suit Against Bayer-Schering
Parker Waichman Alonso LLP Files Suit Against Bayer-Schering on Behalf of Woman Who Developed Nephrogenic Systemic Fibrosis (NSF) from Contrast Agent MagnevistFDA Gadolinium Warning 5/23/07
In May 2007, the FDA requested that the manufacturers of the five gadolinium based contrast agents used in MRIs include a boxed warning – the FDA’s strongest possible safety warning – on product labels highlighting the risk they posed to patients with kidney problems. The FDA warned that patients who are at risk for NSF should be monitored by their doctors, and told to report any symptoms associated with the condition immediately. The FDA has also set up a reporting program so that healthcare providers can report instances of NFS caused by Gadolinium based contrast agents.FDA News
Questions and Answers
FDA Information for Healthcare Professionals PDF
FDA Gadolinium Warning 12/22/06
In December of 2006, the FDA issued its second public health advisory regarding gadolinium based contrast dyes. At that time, the FDA said it had received 90 reports of patients with moderate to end-stage kidney disease who developed NSF after being exposed to gadolinium based contrast agents. At the time of this alert, the FDA said about 215 patients worldwide were known to have NSF. Of those whose medical history were known, all had been exposed to gadolinium contrast agents prior to diagnosis.Public Health Advisory
Questions and Answers
Information for Healthcare Professionals
FDA Gadolinium Warning 6/08/06
In June 2006, the Food & Drug Administration (FDA) issued what would be the first of three warnings on gadolinium contrast dyes. Following the publication of the Dutch NSF study in 2006, the FDA issued an alert to healthcare providers that gadolinium based agents had been tied to multiple cases of NSF. Although these cases were not limited to one gadolinium based contrast agent, three were most often associated with the onset of NSF. Those three were Ominiscan, Magnevist and OptiMark. At that time the FDA warned physicians to screen patients for kidney problems prior to using gadolinium based contrast agents during MRIs.Public Health Advisory
Questions and Answers
Information for Healthcare Professionals
FDA Information for Healthcare Professionals PDF
Gadolinium Injury Lawyers
Our gadolinium injury lawyers are currently investigating the association between gadolinium contrast dyes used during MRI (Magnetic Resonance Imaging) and MRA (Magnetic Resonance Angiography) procedures with the debilitating disease NSF (Neprhogenic Systemic Fibrosis). NSF is a disease that affects people with pre-existing kidney problems. In recent years, several studies have found a compelling link between the use of gadolinium contrast dyes and the onset of NSF. Our gadolinium injury lawyers are currently representing victims of NSF, all of whom developed the disease following exposure to gadolinium contrast dyes used in MRI and MRA procedures. The gadolinium injury lawyers at our firm are dedicated to insuring that people suffering with NSF and their families receive the compensation they deserve from the makers of gadolinium contrast dyes.
Gadolinium Contrast Dyes
The first gadolinium contrast dyes were approved by the Food & Drug Administration (FDA) in 1988 for use in MRI procedures. Gadolinium contrast dyes quickly gained favor in the medical community because the use of older iodine-containing contrast agents was a common cause of hospital-acquired acute kidney failure and was also associated with increased death in kidney patients. Unfortunately, the investigation conducted by our gadolinium injury lawyers has uncovered convincing evidence that gadolinium contrast dyes are not a safe alternative for such patients, as these dangerous drugs expose them to the risk of developing NSF.
Today, there are five gadolinium contrast dyes approved for use in the US: Omniscan by GE Healthcare; OptiMARK by Mallinckrodt/Tyco Healthcare; Magnevist by Bayer/Schering AG/Berlex; ProHance by Bracco Diagnostics and MultiHance by Bracco Diagnostics. Gadolinium contrast dyes are injected into the blood stream of patients right before an MRI. Gadolinium contrast dyes are used in MRIs because they make it far easier for a diagnostician to differentiate between normal and abnormal tissue.
Sometimes gadolinium contrast dyes are also used in MRA procedures, something the FDA has not approved. An MRA is a variation of a traditional MRI that is used to provide pictures of blood vessels inside the body. In many cases, an MRA can provide information that cannot be obtained from an X-ray, ultrasound, or computed tomography (CT) scan. An MRA is often used to detect aneurysms, blood clots or narrowing caused by plaque buildup in the blood vessels leading to the brain, and it is also used to find similar narrowing in the vessels leading to the lungs, kidneys and legs. But the off-label use of gadolinium contrast dyes for MRA requires much larger doses of gadolinium. The gadolinium injury lawyers at our firm have determined that such large doses of gadolinium contrast dyes in MRA procedures put kidney patients at an even greater risk of developing NSF.
Gadolinium and NSF
NSF is a debilitating disease that was first seen in patients in 1997, and it wasn’t mentioned in medical literature until 2000. NSF leads to excessive formation of connective tissue in the skin and internal organs. It 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. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.
There is no known cure for NSF, although in some cases, a kidney transplant has reversed the condition. Symptoms of NSF may appear within two days or even as long as 18 months after exposure to a gadolinium contrast dye. The dosage of the gadolinium contrast dye associated with the onset NSF can vary as well. Some patients have developed the disease after receiving only one dose of the gadolinium contrast dye, while others patients who received a higher dosage also developed NSF. The gadolinium injury lawyers at our law firm have seen how devastating an NSF diagnosis can be for victims and their families, and we are dedicated to helping NSF sufferers in their fight against the companies that manufacture gadolinium contrast dyes.
The investigation conducted by our gadolinium injury attorneys has documented increasing evidence of a tie between gadolinium contrast agents and the onset of NSF. In 2006, Dutch researchers where the first to link NSF with the use of gadolinium contrast dyes. Since 2006, several other studies have found a direct association between NSF and gadolinium contrast dyes. In October 2007, researchers at Massachusetts General Hospital discovered that kidney patients who had undergone MRIs with gadolinium contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents. A Scottish study of dialysis patients at two Glasgow hospitals published around the same time found that of 14 patients diagnosed with NSF, 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 gadolinium but did not develop the disorder. The overwhelming evidence of the connection between gadolinium contrast dyes and NSF highlighted by these studies has convinced the gadolinium injury attorneys at our firm that the makers of gadolinium contrast dyes should compensate NSF victims for their suffering.
FDA Gadolinium Contrast Dye Warnings
In the past few years, the FDA has issued several warnings regarding the use of gadolinium contrast dyes in people with pre-existing kidney disease. Our gadolinium injury lawyers believe that the FDA warnings are more evidence that these drugs pose a serious danger to kidney patients.
Following the publication of the Dutch NSF study in 2006, the FDA warned healthcare professionals that gadolinium based contrast dyes had been tied to multiple cases of NSF. Although these cases were not limited to one gadolinium based contrast agent, three were most often associated with the onset of NSF/NSD. Those three were Omniscan made by GE Healthcare, Magnevist marketed by Bayer Shering Pharma, and OptiMark manufactured by Mallinckrodt, Inc. At that time the FDA warned physicians to screen patients for kidney problems prior to using a gadolinium based contrast agents during MRIs.
In May 2007, the FDA requested that the manufacturers of the five gadolinium based contrast dyes used in MRIs include a boxed warning on product labels highlighting the risk they posed to patients with kidney problems. Then in September 2007, the FDA issued a “Dear Healthcare Provider” letter advising medical practitioners that a blackbox warning, the FDA’s most serious type of warning, had been added to the labels of all gadolinium contrast dyes.
The FDA has advised that people with kidney disease should avoid gadolinium contrast agents. The FDA also recommended that patients who receive a gadolinium contrast dye who are already undergoing dialysis receive a dialysis treatment shortly following administration of a gadolinium contrast dye. Dialysis may help eliminate the gadolinium from the body, however it is not known if this will actually prevent NSF. Finally, the FDA has warned against the use of gadolinium contrast dyes in MRA procedures.
Legal Help for NSF Victims
The gadolinium injury lawyers at our firm are currently evaluating potential NSF lawsuits against the makers of gadolinium contrast dyes. If you or a loved one underwent an MRI or MRA that involved a gadolinium contrast dye, and you now suffer from NSF, you have valuable legal rights. Please fill out our online form for a FREE, INSTANT CASE REVIEW or call our office at 1-800-LAW-INFO (1-800-529-4636) for a free consultation with an experienced gadolinium injury attorney.
