The FDA has 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. Manufacturers of propoxyphene-containing products will be required to strengthen the label, including the boxed warning, to emphasize the potential for overdose and to provide a medication guide to patients stressing the importance of using these drugs as directed. Additionally, the FDA is requiring a new safety study to assess the cardiac effects of propoxyphene at higher than recommended doses. The FDA plans to work with several groups (eg, Centers for Medicare & Medicaid Services, 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.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170763.htm.