FDA Advisory Panel Recommends Banning Darvon and Darvocet

A panel of medical experts which advises the U.S. Food and Drug Administration on certain types of drugs has, by a narrow margin, recommended recalling the longtime painkiller Darvon and its modern version, Darvocet.

By a vote of 14-12 on January 30, 2009, the panel recommended that the agency withdraw Darvon from the market after a day-long hearing held to determine the risks and benefits of the drug. The FDA will now consider the recommendation of its advisory panel before taking action. Most often, the FDA follows the lead of its advisory panel in deciding whether to recall drugs.

Darvon was first approved in the United States in 1957, a time when aspirin and powerful narcotics were the only real alternatives for treating patients in pain. Today, the drug is most commonly prescribed as Darvocet, which includes a dose of acetaminophen and is one of the top 25 most commonly prescribed medications. More than 20 million prescriptions for Darvocet were written in 2007 alone.

Consumer groups and other critics of Darvon argue that with newer, safer pain killers available, the old drug that has been linked to an increased risk of addiction and overdoses has become outdated. Makers of Darvon and Darvocet say the drugs are safe when used as directed and give physicians a valuable tool to use in treating patients in pain.

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