News Flash

New Boxed Warning on Pain Management Medications Containing Propoxyphene

July 09, 2009

Source: The Food and Drug Administration

The FDA is taking actions to reduce the risk of overdose, including fatalities, with patients using pain medications containing propoxyphene.

A new boxed warning will be added to propoxyphene-containing medications to emphasize the potential for overdose as well as a medication guide reinforcing the need to use the medication as directed.

The FDA is requiring additional studies to assess concerns about the effects propoxyphene has on the heart and further evaluations on how propoxyphene-containing medications are being prescribed to the elderly.

Read the complete MedWatch Safety summary, including links to the FDA news release and Q&A's, at:
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170763.htm