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FDA Panel Says Tougher Warnings Needed for Omniscan, OptiMark

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A Food & Drug Administration (FDA)  advisory panel has recommended new warnings for Covidien Inc.’s OptiMark and General Electric’s Omniscan  gadolinium contrast dyes because they may have a higher risk of nephrogenic systemic fibrosis (NSF) than other gandolinium agents on the market.  Some advisers also advocated a similar warning for Bayer’s Magnevist, but the panel did not reach consensus on that issue.

According to Reuters, the warnings proposed for Omniscan and Optimark would contraindicate their use in people with severe kidney disease.   The recommendation represented a “preponderance of opinion” on the panel,  and not a formal vote, Reuters said.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs.  It appears that NSF only develops in people with pre-existing kidney disease. In 2007, the FDA asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about their association with NSF.  Since the warning, the FDA and the makers of gadolinium contrast dyes have continued to collect data about their association with NSF.

According to Dow Jones, at yesterday’s FDA advisory panel meeting, radiologists said that clinicians have essentially stopped using gadolinium agents  in  patients with severe kidney disease.  The panel was also told that reports of NSF have  dropped significantly since the black box warning was mandated.

According to documents released last month by the FDA in advance of yesterday’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.

As we previously reported, Covidien has already decided to modify the label of OptiMark to contraindicate its use in patients with severe kidney impairment because of its association with NSF.

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