The FDA has notified healthcare professionals that Xanodyne has agreed to withdraw propoxyphene (Darvon and Darvocet) from the U.S. market at the request of the FDA. The FDA has requested that the generic manufacturers of propoxyphene-containing products remove their products as well. The market withdrawal of propoxyphene is due to data showing that the drug can cause serious toxicity to the heart (eg, prolonged PR interval, widened QRS complex and prolonged QT interval), even when used at therapeutic doses. The FDA concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses.
Propoxyphene, an opioid analgesic, is indicated for the treatment of mild to moderate pain.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm234389.htm.