The FDA is reporting today that Xanodyne Pharmaceuticals, Inc., the maker of Darvon and Darvocet, has agreed to withdraw the medication from the U.S. market at the request of the FDA. Darvon and Darvocet are the brand names of the prescription pain reliever propoxyphene. The generic manufacturers of propoxyphene have been notified of Xanodyne's decision and have been urged to voluntarily remove their products from the market as well.
According to the FDA press release out today, the FDA sought market withdrawal of propoxyphene after receiving new clinical data showing thatthe drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. Based on this new clinical trial information, the FDA concluded that the risks outweighed the benefits of the drug.
The FDA has advised doctors and other healthcare providers to stop prescribing propoxyphene to their patients. The FDA is also advising patients who are currently taking the drug to contact their health care provider as soon as possible to discuss switching to another pain management therapy.
According to the new data, even standard therapeutic doses of propoxyphene can be harmful to the heart. However, the changes to the heart's electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk of injury will cease.
Propoxyphene is an opioid used to treat mild to moderate pain. It was first approved by the FDA in 1957. Since 1978 the FDA has received two requests to remove the drug from the market citing its potential to damage the heart. Up until now, the FDA had determined that the benefits provided by the pain reliever outweighed its risks.