Wednesday, July 8, 2009

FDA Mandates that Darvocet Must Carry Stronger Warning Labels

The FDA has decided to let painkillers Darvocet, Darvon and their genetic versions stay on the market but has ordered stronger warning against deadly overdoses. Darvocet, which is known generically as propxyphene, is widely used in the U.S. even though doctors consider it to be a “weak pain reliever”.

The group Public Citizen petitioned the FDA to ban the drug in the United States, saying that the small benefit didn’t justify a risk that was adding up to several hundred deaths a year. Britain banned the drugs several years ago citing a trail of suicides and accidental overdoses.
However, in the United States the FDA only ordered that a stern box warning be placed on the drug’s label, and that patients soon start receiving a special pamphlet with every bottle that stresses the risk of taking too much.
Public Citizen is considering whether to appeal the FDA’s decision regarding Darvocet and Darvon.

“This is a reckless decision on the part of the FDA unless they believe Americans are resistant to the death- causing properties of this drug in a way that Europeans and the people in the U.K aren’t,” said Public Citizen’s Dr. Sidney Wolfe. “You’ve got a drug which has a barely perceptible benefit and a very clear risk.”

For more information see: http://www.msnbc.msn.com/id/31785225/ns/health-more_health_news/

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posted by Chavon Williams at 8:07 AM

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