FDA says Darvon to be taken off market

Nov. 19, 2010 at 6:55 PM
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WASHINGTON, Nov. 19 (UPI) -- The manufacturer of painkillers Darvon and Darvocet said it will comply with a U.S. request to take the drugs off the market due to safety concerns.

The U.S. Food and Drug Administration says new clinical data shows the drug propoxyphene "puts patients at risk of potentially serious or even fatal heart rhythms" and says its risks outweigh the benefits, The Wall Street Journal reported Friday.

Darvon is propoxyphene alone, and Darvocet combines that ingredient with acetaminophen.

Xanodyne, the maker of the two branded products, says it will pull the drugs from the market.

The FDA said it's asking makers of generic versions to pull their drugs, too.

Britain ordered propoxyphene off the market in 2005 on concerns that it was too easy to overdose on the drug, and Europe's main medical regulator recommended its removal in 2009.

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