The Los Angeles Times (11/19, Zajac) reported, "The maker of Darvon [propoxyphene] and Darvocet [acetaminophen and propoxyphene] announced Friday that it will stop marketing the widely used painkillers in the US because of a new study linking the active ingredient in the drugs to serious and sometimes fatal heart rhythm abnormalities." Xanodyne Pharmaceuticals Inc. "agreed to the ban at the request of the Food and Drug Administration, which also asked makers of generic versions of the drugs' core compound, known as propoxyphene, to stop selling it in the US."
Bloomberg News (11/19, Peterson) reported Xanodyne "will withdraw Darvon and Darvocet, a product that combines Darvon's active ingredient with acetaminophen." The FDA "requested the move after evaluating study data, and asked makers of generic versions to take them off the market as well." Xanodyne's "new clinical research, combined with new epidemiological data, led the FDA to conclude that propoxyphene's benefits no longer outweigh its risks, said John Jenkins, director of the agency's Office of New Drugs."
The AP (11/19) reported, "Britain and the European Union decided to ban Darvon in 2005 and 2009, respectively, due to a long trend of suicides and accidental overdoses." The FDA said it "decided to take action based on a recent study showing Darvon interferes with the electrical activity of the heart, causing irregular heart rhythms that can be fatal. Xanodyne conducted the study last year at the government's request."
The Washington Post (11/19, Stein) reported, "The FDA has received two requests to remove the drug from the market since 1978 but had previously determined the benefits outweighed the risks." Consumer advocates "welcomed the announcement but sharply criticized the agency for failing to act sooner." The New York Times (11/19) "Prescriptions" blog, the Wall Street Journal (11/20, Dooren, subscription required), HeartWire (11/22), and the CNN (11/19) "The Chart" blog also reported the story.