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 Kentucky company confirmed the move in its own statement.
The FDA also ordered generic drugmakers to stop making and selling low-cost drugs containing the active ingredient in Darvon, called propoxyphene.
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.
“This last study, the cardiac study, was sort of the final piece of the puzzle that told us what the complete picture was,” said Dr. Gerald Dal Pan, director of the FDA’s office of surveillance and epidemiology.
Dal Pan said patients should continue taking the medication until their doctor prescribes a replacement therapy. Other commonly prescribed drugs in the same class are oxycodone and codeine.
But public safety advocates said the agency should have acted sooner to pull a drug with limited benefits and a history of safety problems.
“The FDA’s deadly delay in this case starkly illustrates how one of the most important public health concepts, the precautionary principle, was embraced by the UK and Europe, but was for too long recklessly rejected by the FDA,” said Dr. Sidney Wolfe, of the consumer watchdog group Public Citizen.
Wolfe estimated that at least 1,000 to 2,000 U.S. patients died from taking Darvon since the U.K. banned the product in January 2005.