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OptiMark, Omniscan and Magnevist Carry Higher Risk, FDA Panel Says

Dec 9, 2009 | Parker Waichman LLP
OptiMark, Omniscan and Magnevist Carry Higher Risk

OptiMark, Omniscan and Magnevist Gadolinium Contrast Dyes appear to place people with severe kidney disease

OptiMark, Omniscan and Magnevist gadolinium contrast dyes appear to place people with severe kidney disease at a higher risk of nephrogenic systemic fibrosis (NSF), according to a panel of medical experts.  The Food & Drug Administration (FDA) advisory panel, which met yesterday, has 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 is also reporting 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.

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.

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.  A mountain of evidence indicates that NSF only affects people with severe kidney disease who have been exposed to gadolinium agents.

Gadolinium Contrast Dyes are Approved for use in MRI Procedures

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. 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.  But since the warning was added to the product labels, additional studies have shown that some gadolinium agents may be more dangerous than others.  

According to documents released last month by the FDA in advance of today’s meeting, the highest risk of NSF was associated with Omniscan, Magnevist and OptiMark. The lowest risk was associated with Prohance and Multihance, both marketed by Bracco Diagnotics. However, the FDA was unable to rule out a risk for any of the agents.

FDA staff said it was too early to reach conclusions about Bayer’s Eovist and Lantheus Medical Imaging’s Ablavar, two recently approved gadolinium agents.

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.

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 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.

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.

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