The FDA is requiring the "black box" warning -- the FDA's sternest warning -- on drugs containing propoxyphene to emphasize the potential for overdose. The FDA also ordered more studies of propoxyphene's safety.
But the FDA didn't ban propoxyphene, although an advisory committee narrowly voted in January to recommend such a ban.
The FDA often follows the advice of its advisory committees, but it's not required to do so.
In this case, the FDA decided that drugs containing propoxyphene are an "acceptable option for mild to moderate pain when taken as directed," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said today in a news conference.
Propoxyphene has been on the market since 1957. From 1969 to 2005, the FDA got 91 reports of deaths in people taking propoxyphene. Most of those deaths were drug overdoses and suicide attempts, often involving multiple drugs, Gerald Dal Pan, MD, MPH, director of the FDA's Office of Surveillance and Epidemiology, said during today's news conference.
Woodcock said the FDA took another look at propoxyphene after the nonprofit group Public Citizen filed a petition in 2006 calling for the drug's ban. Woodcock also noted that the FDA has been reviewing other types of pain relievers, including last week's meeting on acetaminophen safety.