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November 20, 2010: Darvon/Darvocet Recall Information and History

Image by amayzun via FlickrThe news is out, but what do people know about how the recall came to be?

The consumer interest group Public Citizen filed a federal lawsuit last year against the U.S. Food and Drug Administration (FDA) claiming that the agency violated the law by failing to act on a petition filed in 2006, which urged the removal of Darvocet, Darvon and generic propoxyphene drugs from the market because they have been associated with over 2,000 accidental deaths, are physically addictive and are no more effective than other safer painkillers.

Darvon and Darvocet contain the narcotic propoxyphene, which is also available as a generic. It has been more than three years since British health authorities cited hundreds of Darvon and Darvocet deaths as the reason they ordered the drug to be phased off of the market, and it has been more than two years since Public Citizen filed their petition urging the FDA to phase the drug out. However, the U.S. drug regulators have not yet taken any actions to protect consumers from the dangerous side effects, and it remains one of the most widely prescribed generic drugs, with approximately 22 million prescriptions in 2007.

The narcotic drug is addictive, yet it is a relatively weak painkiller, say opponents. Public Citizen indicates that it is no more effective at treating most kinds of pain than other safer alternatives, such as ibuprofen (the active ingredient in Advil) and acetaminophen (the active ingredient in Tylenol).

?A large portion of the deaths from propoxyphene occurred because the drug is converted into a metabolite that is highly toxic to the heart and lasts longer in the body than the original compound, resulting in cardiac depression,? said Public Citizen in a statement released February 28, 2006 when they originally filed their petition. ?Adverse cardiac events associated with propoxyphene include an interruption of heart transmission of electrical impulses, slowed heartbeats and a decreased ability of the heart to contract properly.?

According to data from the Federal Drug Abuse Warning Network, deaths related to Darvocet, Darvon and other generic propoxyphene drugs account for over 5% of all drug-related deaths between 1987 and 200

Full post as published by A Georgia Lawyer on November 20, 2010 (boomark / email).