FDA orders "black box" on antibiotics for tendon risks

07/8/2008 | Wall Street Journal, The · Washington Post, The

"Black box" warnings about the risks of tendon rupture will be added to fluoroquinolones, a class of antibiotics that includes Ortho-McNeil's Levaquin and Bayer AG's Cipro, FDA officials announced. The agency, which was sued by consumer group Public Citizen to push for such labels, said it will ask drugmakers to develop a medication guide to alert patients about potential adverse reactions to their products. Manufacturers said they will comply with the FDA's decision but maintained that their treatments' benefits outweigh the dangers.

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Wall Street Journal, The · Washington Post, The

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