FDA Orders Stronger Warning For Propoxyphene

Law360, New York (July 7, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration has ordered manufacturers of drugs containing the pain-killing ingredient propoxyphene to boost the products' warning labels to highlight the risk of fatal overdoses.

The agency announced the move Tuesday in light of data linking propoxyphene and overdoses, saying it would also require manufacturers to provide a medication guide to patients stressing the importance of using drugs such as Xanodyne Pharmaceuticals Inc.'s Darvon and Darvocet as directed.

In addition, the FDA said it had ordered a new safety study assessing unanswered...
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