Darvon, a decades-old painkiller chiefly marketed as Darvocet, should be banned by the U.S. Food and Drug Administration, an expert panel advising the agency recommended Friday.
The advisory panel voted 14-12 to recommend withdrawing Darvon, first approved in 1957. Earlier Friday, the agency said it was reviewing the drug after critics charged it provided little relief and posed a risk for overdose and suicide, the Associated Press reported. The full FDA usually follows the recommendations of its expert panels, but isn't bound to do so.
Darvon, which includes a dose of acetaminophen, is among the top prescribed medications. More than 20 million prescriptions were written in 2007, the wire service said. Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, two firms that market Darvocet, called the medication safe and effective when used as directed.
But critics complained that the government review was too long in coming. "[The drug] has unique risks and no unique advantages," Dr. Sidney Wolfe, a drug safety expert with the consumer group Public Citizen, told the AP. "It has been a big drug of abuse for quite a long time." Public Citizen first sought a ban on Darvon in the 1970s, and the United Kingdom banned its version in 2005, the AP said.
Besides an outright ban, the FDA's other options include requiring stiffer warnings, additional studies or education efforts to alert doctors and patients of potential misuses, the AP reported.