A maker of Darvon and Darvocet has agreed to take the products off the market because the drugs increase the risk for serious abnormal heart rhythms, the U.S. Food and Drug Administration announced. Darvon, which contains the active ingredient propoxyphene, has been on the U.S. market for more than 50 years and was developed by Eli Lilly & Co. Later, the company combined propoxyphene with another pain ingredient, acetaminophen, and sold the pill as Darvocet.
Both drugs are now marketed by private, generic-drug makers including Xanodyne Pharmaceuticals Inc. of Newport, Ky., and Qualitest/Vintage Pharmaceuticals, of Huntsville, Ala. More than 20 million prescriptions were written for the products in 2007, according to the FDA.
The agency said that Xanodyne agreed to remove propoxyphene from the U.S. market after the results of a safety study looking at the impact of the drug on the heart.
The FDA said it’s sending letters to other makers of Darvon and Darvocet to request they also Darvon and Darvocet to carry the agency’s toughest boxed warning discussing the risk of fatal overdose, but rejected calls at the time for the products to be removed from the market.
Derek Humphry adds: Darvon in overdose is lethal but Darvocet is not. See the book ‘Final Exit’ For information only.
