Two popular pain pills, approved for use in 1957 and still widely used, have been pulled from the market in the United States because of their dangerous side effects.
Darvon and Darvocet have been banned from use by the Food & Drug Administration, a move some experts say is long overdue. The drugs, known generically as propoxyphene, were banned in Britain in 2005 and in Europe in 2009. In January 2009, an FDA advisory committee recommended the removal of the drugs, but that recommendation was rejected by the agency. Instead the FDA ordered a study of the drug's effects on the heart.
Link to Heart Problems
When the study showed that propoxyphene is linked to heart rhythm abnormalities, the FDA finally ordered the drug taken off the market. The agency urged doctors to stop prescribing the drugs immediately.
Darvon, an opiate-based medication, is prescribed for mild to moderate pain. Darvocet is propoxyphene combined with acetaminophen. Xanodyne Pharmaceuticals Inc., of Newport, Kentucky, the maker of Darvon and Darvocet, said it would comply with the FDA's recommendation.
The removal of the drug from the market should have little effect on the estimated 10 million people who were taking it, because there are newer, more effective pain killers now available, such as Oxycontin and Vicodin.
Evidence Going Back 30 Years
But the action may be too late for some patients, some observers noted. There has been evidence that Darvon caused heart arrhythmias for more than 30 years. Public Citizen's Health Research Group has lobbied against the drug for years and petitioned the FDA to take action against it in 2006.
More than 1,000 people have died due to use of Darvon, the group said.