MRA/MRI-NSF Injury Attorneys
Restrict Omniscan, OptiMark, FDA Panel Says
A panel convened by the Food & Drug Administration (FDA) has found that Omniscan, OptiMark and Magnevist appear to carry the greatest risk of nephrogenic systemic fibrosis. The group of outside experts recommended that the labeling for OptiMark and Omniscan be updated to restrict their use to patients without severe kidney disease. The panel did not reach consensus on Magnevist, though some members did advocate for a similar warning.
The panel's findings are no surprise to the NSF lawyers at our firm. More than 500 lawsuits over NSF, a debilitating and often fatal disease that appears only in people with severe kidney disease who have been exposed to gadolinium, have been filed in U.S. courts against makers of these drugs. The majority of these lawsuits involve Omniscan.
Omniscan has also been the gadolinium contrast dye most cited in NSF reports filed with the FDA and European regulators. In November 2009, Europe's health regulatory agency said Omniscan, Magnevist and Optimark shouldn't be used in patients with severe kidney problems.
The FDA advisory panel was convened to comment on the agency's latest risk assessment of gadolinium agents, and on filings submitted by the manufacturers. That assessment found that Omniscan, Optimark and Magnevist appeared to carry the highest risk of NSF. The lowest risk was associated with Bracco Diagnotics' Prohance and Multihance, though the danger could not be ruled out for any of the agents.
The FDA staffers who conducted the assessment also recommended that the drug labels note the varying levels of risks with each product. They did not recommend removing any gadolinium agent from the market.
The release of that risk assessment in November 2009 did prompt one company, Covidien, to add a new warning to its OptiMark product. At the time, a spokesperson for the company told Reuters that ?it was prudent to act now, rather than wait for a causal link? to be established? between the imaging drugs and NSF.
All gadolinium contrast dyes already bear a black box warning - the FDA's strongest safety warning - about the risk of NSF. That black box was mandated in September 2007. But according to Reuters, at the advisory panel meeting, most members felt prescribing instructions for Omniscan and Optimark should clearly warn they should not be used in severe kidney disease patients.
Dr. Sidney Wolfe, a panel member and head of Public Citizen?s Health Research Group, was among those pushing for stronger warnings on Omniscan and Optimark. According to Reuters, Dr. Wolfe expressed concerns that leaving the same warning on all the drugs ?may cause more problems than if you distinguish between the drugs as best as you can."
Other 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.
No actual vote was taken at the advisory panel meeting, but the recommendation represented the overall opinion of the panel. The FDA will now determine what, if any, label modifications Omniscan, Optimark and the other agents will undergo. The FDA does not have to follow recommendations of advisory panels, but it usually does so.
OptiMARK Label Changes
In November 2009, the label of OptiMARK was modified to include a contraindication for people with severe kidney impairment. Educational materials for OptiMARK were also updated to help physicians make informed decisions regarding the appropriate use of the agent. The label modification followed news from the FDA that its review of gadolinium contrast dyes had revealed that OptiMARK, along with Omniscan and Magnevist, carried a higher risk of NSF than others.
Though the FDA's drug safety unit said the NSF risk associated with the gadolinium contrast dyes ?does not compel removal of specific (imaging agents) from the U.S. market?, it recommended that the drug labels note the varying levels of risks with each product. While the lowest NSF risk was associated with Prohance and Multihance, the agency said ?the data do not appear to rule out an NSF risk for each of the agents.?
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
MRA/MRI-NSF Injury Attorneys
The MRA/MRA-NSF injury attorneys at Parker Waichman Alonso LLP have been investigating the link between NSF and Gadolinium Contrast Dyes used n Magnetic Resonance Imaging (MRI). NSF is a rare and debilitating disease seen in patients with pre-existing kidney problems. The first Gadolinium Contrast Dyes used in MRIs where approved by the Food & Drug Administration in the mid 1980s. It wasn’t until 1997 that the first case of NSF was diagnosed, and the disease did not appear in medical literature until 2000. Unfortunately, because NSF is a relatively new and rare disease, not much research has been done on the disorder. But the studies that have been done have found a direct correction between NSF and the Gadolinium Contrast Dyes used in many MRI procedures.
NSF and Gadolinium Contrast Dyes Used in MRA/MRI
In 2006, Dutch NSF researchers first discovered the connection between NSF and the Gadolinium Contrast Dyes used in MRI. Since 2006, other researchers have reinforced the Dutch NSF findings. A Yale University study reported that 95-percent of those with NSF had an MRI that involved a Gadolinium contrast dye two to three months before their symptoms appeared. In 2007, researchers at Massachusetts General Hospital found that kidney patients who had undergone an MRI with a Gadolinium Contrast Dye were 10 times more likely to develop NSF than patient who had not been exposed to such agents. The MRI-NSF injury lawyers at Parker Waichman Alonso LLP are currently evaluating cases where victims have been afflicted with NSF due to their exposure to Gadolinium Contrast Dyes used in MRIs.
NSF Symptoms
NSF is an extremely disabling disease 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. It can take some time after Gadolinium exposure for NSF symptoms to appear, and the disease often progresses very slowly. At this time, there is no treatment or cure for NSF. However, improved kidney function does seem to slow the development of the disease. Unfortunately, for many patients with NSF, the only way to improve their kidney function is with a transplant. The MRI-NSF injury lawyers at Parker Waichman Alonso LLP can help victims of NSF obtain compensation for their Gadolinium MRI contrast dye injuries to help them recover lost wages, the costs of medical care, pain and suffering and damages from the makers of Gadolinium Contrast Dye used in MRIs.
Regulatory Action Regarding Gadolinium Contrast Dyes
Despite the fact that MRA procedures are not an approved use of Gadolinium Contrast Dyes, this dangerous practice continues to grow, putting countless people at risk for NSF. According to the National Kidney Foundation, some 20 million people have chronic kidney disease. Obviously, Gadolinium Contrast Dyes used off-label in MRA procedures have the potential to injure millions. For this reason, the FDA has taken steps to warn the medical community and the public about the potential for Gadolinium Contrast Dyes to cause NSF when used in MRI or MRA procedures.
In recent years, the FDA has issued several warnings regarding the correlation between NSF and Galodinium Contrast Dyes used in MRI. In June 2006, the FDA announced that it had learned of 25 cases of patients with kidney failure who received a Gadolinium Contrast Dye for an MRA prior to their diagnosis. At the time, the FDA cautioned that Gadolinium Contrast Dyes, especially at the high, unapproved doses required for MRA, should be avoided unless they are clearly necessary in patients with advanced kidney failure.
In 2007, the manufacturers of the 5 approved Gadolinium Contrast Dyes added black box warnings to the product labels about the risk of NSF in patients with kidney disease. The FDA warned that patients who are at risk for NSF should be monitored by their doctors following procedures with Gadolinium Contrast Dyes.
Despite the ever-increasing evidence that Gadolinium Contrast Dyes used in MRA and MRI procedures puts kidney patients at risk of developing NSF, these agents are still used with great frequency. The MRA-NSF injury attorneys at Parker Waichman Alonso LLP are committed to obtaining the best financial results for the victims of MRA-NSF injuries so that they are able to sustain a high quality of life in spite of their devastating NSF diagnosis.
Legal Help for Victims of NSF-MRA/MRI Injuries
If you or a loved one believes you developed NSF from a Gadolinium Based Contrast Agent used in an MRI, you have valuable legal rights. Please fill out our online form or call 1-800-LAW-INFO (1-800-529-4636) to speak with an experienced NSF-MRI injury attorney.