The FDA will also call for a black-box warning on two old prescription painkillers, Darvon and Darvocet. Both medications contain propoxyphene, which has been sold in the US for more than 50 years. At one time, Darvon was one of the most popular prescription pain relievers on the market.
The advocacy group Public Citizen has asked the agency to take these drugs off the market. Instead, however, the FDA will require manufacturers to conduct further safety studies. The new warning will stress the risk of overdose and will mandate consumer information be dispensed every time a prescription is filled. Consumers need to be aware of the dangers, but Dr. Janet Woodcock of FDA’s Center for Drug Evaluation and Research points out that it is acceptable for relieving mild to moderate pain if it is used as directed.
