WASHINGTON — 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 FDA also ordered generic drugmakers to stop making and selling low-cost drugs containing the active ingredient in Darvon, called propoxyphene.
Britain and the European Union banned Darvon in 2005 and 2009, respectively, due to a long trend of suicides and overdoses.
The FDA based its decision 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.
