FDA MedWatch

Propoxyphene-containing Products

Audience: Pharmacists, Pain management healthcare professionals

07/07/2009 - FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. The agency will require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products and to provide a medication guide to patients stressing the importance of using the drugs as directed.

FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action. To further evaluate the safety of propoxyphene, FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.

Read the complete MedWatch Safety summary, including links to the FDA news release and Q&A's, at:

www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuman
MedicalProducts/ucm170763.htm