An FDA advisory committee recommended a ban on Darvon, a prescription painkiller that has led to addiction and suicide. The committee voted 14-12 that Darvon’s risks outweigh its benefits, said FDA spokeswoman Karen Riley. The FDA is not required to follow its committees’ recommendations, but it often does.
Darvon, mainly marketed as Darvocet, was first approved in 1957 when there were few alternative for treating pain. Darvon is one of the top 25 most prescribed medications, with more than 20 million prescriptions written in 2007.
Public Citizen, a consumer group, petitioned the FDA to withdraw the drug because it poses an overdose risk and a potential to be involved in suicides. Dr. Sidney Wolfe, a drug safety expert with the group, first sought a ban in the 1970s. "With a drug that has almost no evidence of benefit, any risk is unacceptable," he said. He recommends that Darvon be withdrawn gradually because some patients have become dependent on it.
Two companies that market the drug, Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, say the medication is safe when used as directed. They noted that many other painkillers have been abused by patients, some with far worse consequences.
If the FDA does not follow the recommendation, it may take other steps such as requiring more warnings, safety studies, or educational programs for doctors and patients.