FDA and MRI Contrast Agents... the Saga continues...

(DIAGNOSTIC IMAGING) -- FDA sharpens MR contrast warning, singles out three agents as ‘inappropriate’ Three of the most popular MR contrast agents—Magnevist by Bayer Healthcare, Omniscan by GE Healthcare, and Optimark by Covidien—will soon carry labels warning that their use is “inappropriate” for patients with acute kidney injury or chronic severe kidney disease. These and other gadolinium-containing agents will also carry new warnings emphasizing the need to screen patients for kidney dysfunction that puts them at risk for nephrogenic systemic fibrosis, the rare but potentially fatal condition that led the FDA to require warning labels on these agents in 2007. The new labels are expected within two months. Manufacturers are now reviewing text sent them by the FDA in early September. Dr. Dwaine Rieves, director of the FDA’s division of medical imaging products, described the text written by the FDA as a “minimum expectation” for the labeling. Manufacturers can enhance it or make alternative proposals, Rieves said, subject to FDA approval.

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