Two FDA committees met yesterday to discuss the future of gadolinium warnings. Gadolinium is a contrast dye given to some patients before MRIs and MRAs that better highlights damaged parts of the body. Unfortunately, when given to patients with impaired renal function, it can be deadly.
The committees recommended that two particular brands of gadolinium dye, GE Healthcare’s Omniscan and Covidien’s OptiMark, should feature enhanced warnings against use in patients with severe kidney disease (the drugs all feature a warning about the risks of nephrogenic systemic fibrosis). After reviewing evidence, the committees clearly believe that these two products are more dangerous than the other gadolinium-based contrast agents on the market, including Bayer’s Magnevist. Whether the FDA takes action on the panel’s opinion remains to be seen.
GE, for its part, is arguing against the changes. They claim that there is insufficient evidence that any gadolinium-based contrast agent is more dangerous than any other. This fits the profile of GE’s approach on all things related to the gadolinium litigation—they are fighting everything tooth-and-nail, sometimes unreasonably so.
In fact, Covidien appears poised to receive the most conscientious drug company award—they have already made moves to modify their label, contraindicating use in patients with severe kidney dysfunction. We like to see the drug companies step up to their responsibilities, especially to prevent more injuries.
In other gadolinium news, it looks like the first prospect for trial is Bayer’s Magnevist in the San Francisco Superior Court (a non-MDL case). The Plaintiff, Peter Gerber, alleges that Magnevist caused him to develop nephrogenic systemic fibrosis (NSF).
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