Darvon, Darvocet Withdrawn in U.S. Over Heart Risks
This article is for subscribers only.
Darvon, a 53-year-old pain pill, will be pulled from the U.S. market after a study found potentially fatal heart risks in healthy people who take the medicine at the recommended dose.
Xanodyne Pharmaceuticals Inc., the drug’s owner since 2005, will withdraw Darvon and Darvocet, a product that combines Darvon’s active ingredient with acetaminophen, Food and Drug Administration officials said today in a statement. The agency requested the move after evaluating study data, and asked makers of generic versions to take them off the market as well. Darvon’s active ingredient, the opioid propoxyphene, had been approved in 1957 for treating mild to moderate pain.