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Darvon, Similar Drugs to Carry Stronger Warnings

Posted on Jul 08, 2009

 
Read Article: The Washington Post      
 
The Food and Drug Administration said Tuesday that it will require stricter labeling of drugs containing propoxyphene, a mild opioid painkiller that the European Union's FDA-equivalent decided last month to phase out of use.

The trade name of the drug is Darvon. Combined with acetaminophen -- a non-addictive painkiller that FDA issued a warning about last week -- it is sold as Darvocet.

The activist organization Public Citizen in 2006 petitioned the FDA to ban propoxyphene. In January, a committee of experts advising the agency voted 14 to 12 that the drug should be withdrawn. On June 25, the European Medicines Agency announced the drug would be phased out of use.

In its decision Tuesday, however, the FDA concluded that propoxyphene is useful enough to remain on the market, at least for now.

Propoxyphene has been on the market since 1957. From 1969 through 2005, 91 deaths attributed to the drug have been reported to the FDA, although that is assumed to be only a small fraction of the total fatalities. Some of the deaths may have occurred because of an effect on the heart called "QT prolongation," which can lead to a deadly arrhythmia.

 

 

 

 

 

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