FDA’s advisers recommend a ban on Darvon

WASHINGTON — Government medical advisers Friday recommended a ban on Darvon, a prescription medicine that’s been used to treat pain for more than 50 years but left a trail of problems such as addiction and suicide.

A Food and Drug Administration advisory panel voted 14-12 to recommend withdrawing Darvon after a daylong hearing examining its risks and benefits. The FDA is not required to follow the recommendations of its advisers, but often does so.

Darvon was first approved in 1957, when there were few alternatives for treating pain except aspirin and powerful narcotics. Now mainly marketed as Darvocet, which includes a dose of acetaminophen, the drug remains one of the top 25 most commonly prescribed medications. More than 20 million prescriptions were written in 2007.

The consumer group Public Citizen had petitioned the FDA to withdraw Darvon because the drug offers relatively weak pain relief and poses an overdose risk, with the potential to be used in suicides.

“With a drug that has almost no evidence of benefit, any risk is unacceptable,” said Dr. Sidney Wolfe, a drug safety expert with Public Citizen who first sought a ban in the 1970s. “Hopefully the FDA will follow the vote of its advisers.”