A Food and Drug Administration advisory panel voted 14-12 to recommend withdrawing Darvon, a prescription medicine that's been used to treat pain for more than 50 years. The pills known as Darvon and Darvocet were said to cause problems such as addiction and suicide and their benefits did not outweigh their risks.

The final decision on whether or not to remove the pills however rests with the FDA who is not required to follow the recommendations of its advisers though it often does. Sharon Hertz, the deputy director of FDA's anesthesia, analgesia and rheumatology products division, said the agency would also examine whether it could order post-market studies or change the drugs' labels.

First approved in 1957, Darvon which is now marketed under the name of Darvocet, remains one of the top 25 most commonly prescribed medications to approved to treat mild to moderate pain. The drug contains the active ingredient propoxyphene and was developed by Eli Lilly & Co. Later another pain ingredient acetaminophen was added and this pill was then sold under the name of Darvocet. Both drugs are now marketed by private, generic-drug makers including Xanodyne Pharmaceuticals Inc. of Newport, Ky., and Qualitest/Vintage Pharmaceuticals, of Huntsville, Ala. According to the FDA more than 20 million prescriptions were written for the products containing propoxyphene in 2007.

Public Citizen, a consumer group had petitioned the FDA to remove the drug Darvon as there is little evidence the drugs are effective and they carry risks of death from heart problems. The petition said the products should be removed from the market because they are "relatively weak" painkillers and said "toxicity develops at only slightly above the recommended daily dose."The companies Xanodyne Pharmaceuticals Inc. and Qualitest/Vintage Pharmaceuticals, who market the drug, however say the medication is safe and effective when used as directed. James B. Jones, Xanodyne's vice president for medical affairs said the company would discuss the panel meeting with the FDA "and come up with a plan on how to move forward."

In its petition, the group cited data from the Drug Abuse Warning Network, implicating propoxyphene in 5.6% of drug-related deaths from 1981 to 1999. This uses a sample of nationwide autopsy information from medical examiners and Public Citizen also said the network reported 2,110 accidental deaths related to propoxyphene over the same period. Dr. Sidney Wolfe, director Public Citizen's health research group on Friday in a presentation before the advisory panel presented updated findings from the drug abuse network which linked 503 deaths in which propoxyphene was listed as a contributing factor in 2007. "All drugs have risks," Wolfe said. "If they don't have benefits they need to come off the market."

The FDA said a review of its adverse-event reporting data base showed 3,028 serious and non-serious reports from 1957 through Sept. 24, 2008, associated with propoxyphene. Of those, 2,136 reports were considered serious and included 1,452 deaths. Many of the serious-event reports included reports of suicides, intentional drug overdoses, heart attacks and unintentional drug overdoses, the FDA said. The agency added that some of the serious adverse-event reports also listed more than one type of drug.