The Food and Drug Administration will require stricter labeling of drugs containing propoxyphene, a mild opioid painkiller, and one that the European Union’s FDA-equivalent decided in June 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 in early July – it’s sold as Darvocet. As we have reported previously, Public Citizen petitioned the FDA in 2006 to ban propoxyphene. In January, a committee of experts advising the agency voted 14 to 12 that the drug should be withdrawn. On June 25th, the European Medicines Agency announced the drug would be phased out of use.

But in its decision last month 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 were reported to the FDA. Actually, 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,” commonly referred to as a black-box 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% of Darvon and Darvon-like drugs are used by folks who are 65 and older.

Source: Washington Post

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