The maker of the painkiller Darvon is pulling the drug off the market at the request of public health officials who say the more than 50-year-old pill causes potentially deadly heart rhythms.
The Food and Drug Administration said Friday that Xanodyne Pharmaceuticals had agreed to halt all U.S. marketing of Darvon and the related brand Darvocet, which have been subject to safety concerns for decades. The Kentucky company confirmed the move in its own statement.
The FDA also called on generic drugmakers to stop marketing low-cost drugs containing the active ingredient in Darvon, called propoxyphene.
Britain and the European Union decided to ban Darvon in 2005 and 2009, respectively, due to a long trend of suicides and accidental overdoses.
FDA officials said they 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.