Federal regulators requested the removal of popular painkillers Darvon and Darvocet from the U.S. market on Friday. Propoxyphene (generic name), puts patients at risk of potentially serious or fatal heart rhythm problems, according to the U.S. Food and Drug Administration (FDA).
Doctors should stop prescribing the drugs, both which are made by Xanodyne Pharmaceuticals. Patients currently taking these drugs should consult their medical doctor before discontinuing use, recommends the FDA. All generic drugs that contain propoxyphene will also be withdrawn.
The opioid, first approved by the FDA in 1957 to treat mild to moderate pain, is sold under a variety of names, including Darvon, which is the drug alone, and Darvocet, which is the drug combined with acetaminophen.
The decision to remove the drug came after the FDA reviewed a new trial study that looked at the drug’s impact on heart rhythms.
The agency has received two requests to remove this drug from the market, since 1978, but concluded the benefits for pain relief at recommended dosages, outweighed safety risks until now.
For more information, please refer to the FDA press release and view a video about the action.