The U.S. Food and Drug Administration has asked the company that makes the highly popular narcotic painkiller Darvon to pull the drug from the market because it can cause fatal heart rhythms.
The FDA asked Kentucky-based Xanodyne Pharmaceuticals Inc to stop selling Darvon and Darvocet after new data confirmed fears that the active ingredient, propoxyphene, could cause serious or even fatal heart rhythm abnormalities.
The decision means patients will have even fewer safe options to manage pain. The FDA said 10 million patients took Darvon or a generic version in 2009 and 18 million prescriptions were dispensed.
The FDA noted that many people take the drug and that there are few choices equivalent to the mild opioid. These include over-the-counter pain relievers such as aspirin, ibuprofen and acetaminophen, codeine, oxycodone or hydrocodone. Aspirin and ibuprofen can cause fatal bleeding and codeine can cause severe constipation.
The FDA said it was difficult to show that deaths associated with Darvon use were not, in fact, overdoses. But a comparison with similar drugs showed propoxyphene was more dangerous. “Over a five-year period, the number of drug-related deaths was approximately 16 deaths per 100,000 prescriptions for propoxyphene, 10 deaths per 100,000 prescriptions for tramadol and 8 deaths per 100,000 prescriptions for hydrocodone,” the FDA said in a statement.
The FDA said it was advising healthcare professionals to stop prescribing propoxyphene and said patients taking it should speak to a doctor about switching to another drug as soon as possible. “Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks,” the FDA said.
The FDA’s Dr. Gerald Dal Pan said Darvon does not cause permanent damage to the heart. “Once patients stop taking propoxyphene, the risk will go away,” he said.
For the FDA’s report and other information: