The announcement ended a 32-year dispute over the safety of the 53-year-old drug. The F.D.A. recommended doctors switch patients to other painkillers, notably Extra Strength Tylenol or acetaminophen.
Propoxyphene has been shown to have very little effect on pain. Many studies showed no significant improvement by adding it to acetaminophen. Propoxyphene also has a narrow margin of safety between the recommended dose and a harmful dose or fatal overdose, according to the F.D.A. review and other experts.