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FDA Panel: Pull Darvon from Market

An FDA advisory panel on Friday voted in favor of removing the popular prescription painkiller Darvocet from the market, based in part on questions about the overall effectiveness of the drug and its links to overdose, addiction, and suicide.

The U.S. Food and Drug Administration (FDA) advisory panel of medical experts voted 14 to 12 in favor of removing Darvon/Darvocet from the market. The consumer advocacy group Public Citizen had recently petitioned the FDA to pull Darvon/Darvocet from the market because of perceived doubts about the effectiveness of the drug, especially in light of overdose and addiction risk tied to the painkiller, heart problems associated with the drug, and its frequent use in suicide attempts. CNNMoney.com reports that "the FDA will make the final decision, and given the essentially split vote it's not clear the FDA will take the products off the market."

Darvon/Darvocet (propoxyphene) has been prescribed to relieve moderate pain since 1957. Taken in high doses (by itself or in combination with other drugs), Darvon/Darvocet has been associated with drug-related deaths, and the painkiller should not be taken with other drugs that cause drowsiness -- including alcohol, tranquilizers, sleep aids, antidepressants, or antihistamines.

• CNNMoney.com: FDA Panel Narrowly Recommends Darvon Be Pulled from Market
• Darvon/Darvocet: Health and Legal Information (FindLaw)
• FDA Index to Drug-Specific Information (FDA.gov)
• FDA Center for Drug Evaluation and Research (FDA.gov)

Full post as published by FindLaw's Common Law on February 03, 2009 (boomark / email).