According to the American College of Radiology advisory, as of December 2009, NSF has been documented in 382 patients who received Omniscan; in 195 patients who received Magnevist; and in 35 patients who received OptiMARK.
In addition to recommending that these agents not be used in people with kidney disease, the group also suggests doctors should obtain renal function tests on their patients at least six weeks before performing an MRI that requires contrast injection.
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. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death.
While not much is known about the disease, a growing mountain of evidence indicates that NSF is most likely to occur in people with severe kidney disease who have been exposed to a gadolinium contrast dyes. Since 2007, all gadolinium agents sold in the U.S. have carried the same black box warning – the Food & Drug Administration’s (FDA) strongest safety notice – regarding the risk of NSF.
GE Healthcare and the other makers of gadolinium agents are named in approximately 500 lawsuits filed by NSF patients, most of which have been consolidated in the U.S. District Court for the Northern District of Ohio as part of a multidistrict litigation (MDL) before Judge Dan Polster. The first trial in the multidistrict litigation, involving Omniscan, had been scheduled to start later in May, but that case has settled. The next Omniscan trial is slated for later this year.
Bayer's Magnevist, as well other gadolinium contrast dyes, including General Electric's Omniscan and Covidien's OptiMark, have been named in over 500 lawsuits filed by people who claim they or their loved ones developed NSF following exposure to one or more of the gadolinium-based MRI contrast dyes.
NSF is an often-fatal disease that 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.
There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death. While not much is known about the disease, a growing mountain of evidence indicates that NSF only occurs in people with severe kidney disease who have been exposed to a gadolinium contrast dye.
In 2007, the U.S. Food & Drug Administration (FDA) mandated a black box warning about the risk of NSF for all gadolinium agents. The agency is now considering tougher warnings that could restrict the use of some gadolinium agents to only patients without severe kidney disease, following a risk assessment that found Omniscan, OptiMark and Magnevist appeared to carry a higher risk of NSF than other gadolinium products on the market.
Most NSF lawsuits filed around the country have been consolidated in federal court in the Northern District of Ohio. However, according to Law.com, the Magnevist lawsuit scheduled for trial in January is one of 20 to 30 California NSF lawsuits that have been consolidated before San Francisco Superior Court Judge Richard Kramer. While this suit only names Bayer as a defendant, General Electric is also a major defendant in the California litigation.
Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. A mountain of evidence indicates that NSF only affects people with severe kidney disease who have been exposed to gadolinium agents.
This horrific and often deadly disease leads 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 are currently no effective treatments for NSF.
At yesterday's meeting, the FDA advisory panel recommended a stronger NSF warning for both Covidien Inc.'s OptiMark and General Electric's Omniscan that contraindicates the use of these agents in people with severe kidney disease, according to a Reuters report. Reuters also said that some on the FDA panel also pushed for a similar warning on Bayer's Magnevist, but the advisers were not able to reach a consensus on that issue.
As we've reported previously, 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 2007.
According to Reuters, Dr. 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. Leaving the same warning on all the drugs "may cause more problems than if you distinguish between the drugs as best as you can," Dr. Wolfe said.
Members of the FDA advisory panel said labeling for the products needs to keep pace with how the drugs are being used in the real world. According to a Dow Jones report, radiologists speaking at yesterday's meeting told the FDA that clinicians have essentially stopped using gadolinium products in patients with severe kidney disease. The panel was also told that the number of NSF reports have dropped significantly since the FDA mandated the black box.
The panel was not asked by the FDA to actually vote on the issue of a new warning for any of the gadolinium products, but the recommendation on OptiMark and Omniscan did represent a "preponderance" of opinion on the issue, Reuters said.
The FDA will make the final decision on any label changes. The agency does not have to follow recommendations of advisory panels, but it usually does so.
Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. In addition to Omniscan, Magnevist and OptiMARK, other agents on the market include Prohance and Multihance, both by Bracco Diagnotics.
NSF is a debilitating disease that 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. NSF is a relatively new disease. In fact, the first known diagnosis of NSF only occurred in 1997, but it wasn’t until September 2000 that details of the disease were published in the medical journal Lancet.
It appears that NSF only develops in people with pre-existing kidney disease. In 2006, Dutch researchers were the first to link NSF with the use of gadolinium contrast dyes. In September 2007, the FDA asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided.
According to documents released yesterday by the FDA, the highest risk of NSF was associated with Omniscan, Magnevist and OptiMARK. The lowest risk was associated with 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 chances of developing NSF was 4 percent among patients with severe kidney impairment.
According to a Reuters report, Covidien has already decided to modify the labeling of OptiMARK. 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.
Gadolinium contrast dyes like Magnevist are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. In addition to Bayer's Magnevist, these dyes include: Omniscan by GE Healthcare; OptiMARK by Mallinckrodt/Tyco Healthcare; ProHance by Bracco Diagnostics and MultiHance by Bracco Diagnostics.
In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the products’ labels regarding their association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents.
NSF is a debilitating disease that 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.
According to Bloomberg.com, as of February Bayer faced 241 lawsuits over Magnevist. The company confirmed that it had entered into settlement discussions for about 40 of those.
“We can confirm that we have reached agreements in principle with several of the plaintiffs in the U.S. to settle without admission of liability", a Bayer spokesperson told Bloomberg.com
An attorney for NSF plaintiffs told Bloomberg.com that the settlements at this time were tentative, and that dollar amounts could not be disclosed. A second plaintiffs' attorney said that for now, Bayer was settling cases in which a biopsy confirmed a diagnosis of NSF, and Magnevist was the only contrast agent used.Bad Boys II movie
NSF is a devastating condition that affects people with pre-existing kidney problems. There is currently no cure for NSF and no one understands its specific cause. The disorder 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.
The evidence that gadolinium contrast agents play a role in the development of NSF is fast becoming irrefutable. Dutch scientists made the first connection between NSF and gadolinium in 2006. Since then, researchers at Yale University have reported that 95-percent of those with NSF had undergone a Magnetic Imaging Resonance (MRI) procedure that involved a gadolinium contrast dye 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 contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents.
In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents.
According to the lawsuit, the plaintiff received an injection of Magnevist gadolinium contrast dye on March 23, 2001. The Brooklyn Center, Minn. woman was diagnosed with NSF in February 2007. The lawsuit, which names Bayer-Schering and its subsidiary Berlex Laboratories as defendants, says that the plaintiff continues to suffer from the severe, debilitating and progressive fibrotic changes associated with NSF. This has permanently disabled, disfigured and severely impaired the plaintiff.
The lawsuit alleges that Magnevist is defective, and that the defendants failed to adequately test Magnevist and failed to warn patients about its potential to cause NSF. The lawsuit further alleges that the chemical make-up of Magnevist makes it more likely that gadolinium will become free within the bodies of recipients, thereby making it more likely that kidney patients will develop NSF.