Darvon, Similar Drugs to Carry Stronger Warnings

Tuesday, July 7, 2009; 8:05 PM

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 In January, a committee of experts advising the agency voted 14 to 12 that the drug should be withdrawn.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.

The drug will now carry a "boxed warning" and pharmacists will be required to give patients information stressing the hazards of taking higher-than-prescribed doses. The FDA will also ask the Medicare program and the Veterans Health Administration for their records on the safety of propoxyphene in the elderly.

About 22 million prescriptions for propoxyphene-containing painkillers are written each year. (In comparison, the most popular prescription painkiller, a hydrocodone and acetaminophen combination sold as Vicodin, sells 120 million prescriptions.) Nearly 40 percent of Darvon and Darvon-like drugs are used by people 65 and older.

-- David Brown

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