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FDA Mandates Tougher Warnings for Pain Pills
Date:7/7/2009

ormation on deliberate overdosing, Woodcock said.

Last month, European regulators called for the withdrawal of dextropropoxyphene from the market because people taking the 50-year-old drug have been dying from overdoses.

Dextropropoxyphene, which is called propoxyphene in the United States, is an opioid widely used to treat mild to moderate pain. It was first introduced in the United States in 1957 under the brand name Darvon and is marketed today by a wide number of generic drug makers.

Last week, an FDA advisory panel recommended that the popular prescription painkillers Vicodin and Percocet, which combine acetaminophen with an opiate narcotic, be banned.

Darvocet contains acetaminophen.

More information

The U.S. Food and Drug Administration has more on propoxyphene.



SOURCES: July 7, 2009, teleconference with Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, and Gerald Dal Pan, M.D., director, office of surveillance and epidemiology, U.S. Food and Drug Administration


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