FDA advisers have recommended that Darvon, a commonly prescribed painkiller, should be pulled off the market over concerns the drug does not offer strong pain relief and poses risk of overdose and potential suicide. The experts said the benefits of the drug didn’t outweigh the risks and therefore the product should be removed from the U.S. market.

 

The advisory panel voted 14 to 12 to recommend its withdrawal.

Darvon, one of the top prescription painkillers, also marketed as Darvocet, is made by Eli Lilly and marketed by Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals. The drug was banned in the U.K. in 2005.

 

Public Citizen, a public advocacy organization, has pressed the FDA to pull the drug off the market arguing that it actually offers a weak pain relief and poses an overdose risk. The petition said the products are “relatively weak” painkillers and added that “toxicity develops at only slightly above the recommended daily dose.” The lawsuit cited data implicating propoxyphene in 5.6 percent of the drug related deaths from 1981 to 1999.

 

FDA also said it found 1,452 deaths associated with propoxyphene from 1957 through September 2008, but the reports listed more than one drug. The makers of the drug say the medication is safe and effective when used as directed. Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, two of the generics makers selling the products noted that more than 600 million scripts for the drugs have been dispensed over the past 50 years.

The FDA is expected to decide whether to accept or reject the panel’s recommendation.