FDA Advisors Meet on Gadolinium Dyes; Find Omniscan, OptiMark and Magnevist are Most Dangerous

A panel of medical experts has found that several gadolinium contrast dyes – <"http://www.yourlawyer.com/articles/read/17387">OptiMark, Omniscan and Magnevist – appear to carry more risk of nephrogenic systemic fibrosis (NSF) than others currently on the market. The advisory panel met yesterday at the behest of the U.S. Food & Drug Administration (FDA) to discuss possible labeling changes for the gadolinium agents.

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.

This entry was posted in Gadolinium, Pharmaceuticals. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.