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.

The FDA is also requiring that the manufacturer conduct a safety study to determine the risks of propoxyphene on the heart when taken above the recommended dose.

The agency also denied a  2006 citizen petition to remove Darvon and other propoxyphene-containing drugs from the market.  The advocacy organization Public Citizen had petitioned the FDA to ban propoxyphene drugs because of potential heart problems, risks of abuse, fatal accidental overdoses, and relatively weak painkilling effectiveness.

On June 25, 2009, the European Medicines Agency (EMEA) recommended that member states gradually withdraw propoxyphene products from their markets.  The EMEA recommendation was based on the number of suicides and accidental fatal overdoses of the drug and on their conclusion that there is no evidence that propoxyphene is more effective than other available pain medicines.   The medicine was withdrawn from the United Kingdom market in 2005 for similar reasons.

More information from the FDA about the decision and about proproxyphene.

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