Tag Archives: propoxyphene

Darvon Taken Off the Market

Xanodyne Pharmaceuticals has withdrawn Darvon®, Darvon-N®, and Darvocet® from the US market at the request of the FDA. Even in recommended doses, Darvon (propoxyphene) can cause changes in heart activity which can be seen on an electrocardiogram (ECG) adding to the risk of serious changes in heart rhythm. On November 19, 2010, The FDA recommended that health professionals stop prescribing any propoxyphene immediately and that patients who are using it contact their doctor about the right way to stop. If your doctor has prescribed a drug that contains Darvon for you, the doctor should contact you to discuss other ways of managing pain and safely discontinuing its use.

FDA Sets Limits on Darvon and Darvocet but Doesn't Recommend Market Withdrawal

Despite recommendations from two of its advisory committees for a phased withdrawal of propoxyphene-containing products, the Food and Drug Administration won’t be taking them off the market.  Instead they’ll require a black box warning on the label and a medication guide for patients letting them know of the serious risks of death from effects on the heart or overdose. Best known by brand names Darvon® and Darvocet®, the pain medicines have a high risk for fatal overdose when not used as prescribed.  Opiates, they are prescribed for mild to moderate pain.  However, the FDA says that benefits of the medicines when taken at recommended doses outweigh risks at this time.