A pain pill that's been used for 52 years could be pulled off the market if the Food and Drug Administration decides it doesn't work very well, and since it carries formidable safety risks. The pills, sold as Darvon and Darvocet
are approved to treat mild to moderate pain. But they have been shown to be addictive, and are linked to deaths in patients, when used with liquor and other drugs.
The FDA advisory panel meeting came about because of a petition, and then a lawsuit from Public Citizen, a public-advocacy organization, that has asked the agency to remove the products from the market. But the panel vote was extremely narrow, 14 to 12, deciding that the benefits of the old drug didn't outweigh the risks. It is now up to the FDA to make the final decision, and because the vote was so close, it is not clear that the agency will actually take the products off the market.
Sharon Hertz, who is the deputy director of FDA's anesthesia, analgesia and rheumatology products division, said the agency will be looking into whether it could do a post-market study, or change the drugs' label.
Darvon contains the active ingredient propoxyphene and was developed by Eli Lilly & Co. and put on the market 50 years ago. Later, the company combined propoxyphene with another pain ingredient, acetaminophen, and sold the pill as 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. More than 20 million prescriptions were written for the products in 2007.
In a presentation before the advisory panel Friday, Dr. Sidney Wolfe, director Public Citizen's health research group, presented updated data from the drug- abuse network, which showed 503 deaths in which propoxyphene was listed as a contributing factor in 2007. He told the panel...
"All drugs have risks. If they don't have benefits they need to come off the market."
In 2005, U.K. health authorities said the benefits of the drugs didn't outweigh the risks and announced a phased withdrawal of the products over a three-year period.