Xanodyne Pharmaceuticals Inc.

In other action, a 50-year-old painkiller linked to deadly overdoses needs tougher warnings and more research, U.S. regulators said, rejecting calls from advisers and a consumer group to pull the product from the market. Propoxyphene-containing products, sold as Darvon, Darvocet or in generic form, must add a boxed warning about the risk of excess use, the FDA's strictest caution. The agency also ordered closely held Xanodyne Pharmaceuticals Inc. (Newport KY) and generic makers of the drugs to study their effects on the heart at higher-than recommended doses. Public Citizen, a Washington consumer group, prompted the FDA to re-evaluate the safety of Darvon in a 2006 petition that cited more than 2,000 accidental deaths linked to the drug. Outside advisers to the FDA voted 14-12 in January that Darvon's risks outweighed its benefits. The agency disagreed, saying most overdoses are intentional and patients should have access to it.