FDA Expresses Concerns about Certain Pain Meds

Patient safety concerns resulted in tightening of regulations on two pain medicines by the U.S. Food and Drug Administration (FDA). 

Box warnings of the medicines containing the opioid propoxyphene must note the potential for overdose and importance of using medicines as directed.  This includes medicines such as Darvon and Darvocet, (propoxyphene with acetaminophen).  The FDA requested an additional study on how higher than recommended doses of propoxyphene-containing medicines might affect the heart, findings and other data might yield more regulatory action. 

The FDA is also concerned about acetaminophen and liver damage due to unintentional overdoses of over-the-counter products that contain this drug.  The current recommendation is to check with your healthcare provider about safe doses of acetaminophen products, such as Tylenol, APAP, Liquiprin, and Panadol.

Revised August 24, 2009