In January 2009, an FDA advisory panel voted to recommend a recall of Darvocet and Darvon, two forms of the drug propoxyphene, for the reason that the drug provides little, if any, benefits over other painkillers, yet poses potentially life-threatening risks.
The drugs have been banned in the U.K. since 2005 for the same reasons, and the consumer group Public Citizen filed a petition with the FDA in 2006 requesting the drugs be taken off the market. According to Public Citizen, Darvocet has been linked with over 2,110 reported deaths between 1981 and 1999, as the painkillers accounted for 5.6% of all drug deaths during that time. Darvocet is also consistently mentioned as one of the top drugs found in peoples' systems during autopsies.
Drug Recall
The Director of the Health Research Group at Public Citizen testified before the FDA panel on January 30, 2009 to the risks posed by Darvocet. He stated that Darvocet possessed "one of the most unfavorable benefit-to-risk ratios ever seen for a drug. This is not to say that there was insufficient evidence for a ban 30 years ago when we first petitioned the Food and Drug Administration (FDA) to withdraw the approval."
Other sources supporting this statement includes DAWN, The Federally-funded Drug Abuse Warning Network, which collects data from emergency rooms and medical examiners concerning drugs which have been determined to be related to emergency room visits or deaths. DAWN reports that propoxyphene-related death cases rose from 446 in 2006, to 503 in 2007. The cases in which the death was reported as accidental outnumbered the cases in which the manner of death was reported as suicide in both years.
These reports may be due to the addictive nature of Darvocet, increasing the risk of over dose. Because most of the drug is converted into a metabolite that is highly toxic to the heart and lasts longer in the body than the original compound, overdosing on Darvocet can result in cardiac depression. These effects associated with propoxyphene include an interruption of heart transmission of electrical impulses, slowed heartbeats and a decreased ability of the heart to contract properly.
Testimonies For Common Painkiller Result in Recall
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