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Public Citizen Urges FDA to Issue Darvon and Darvocet Recall

UPDATE 11/19/2010: The FDA announced that a Darvocet and Darvon recall in November 2010.

On Friday, the consumer interest group Public Citizen filed a federal lawsuit against the U.S. Food and Drug Administration (FDA) in Washington, D.C. The lawsuit alleges 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 very addictive, yet it is a relatively weak painkiller. 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 2006.

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52 comments

  1. rick Reply

    For god sales people I took the drug spairingly 1/2 tab for back injery for years when I finally took the whole pill for a few days it gave me a heart attack, at 40 , took again full 1 tab dosage as perscribed only once a day for back injury in 2003 within i week another heart attack, then took it in early 2005 for 3 days with another heart attack. Maybe it doesn’t hurt all people but who is to say my life is worth nothing it is just a statistic, I am an acceptable casualty for the drug manufactures.

  2. Julia Reply

    This is so interesting to me. When I was 17 I was in a bad car accident that left me pretty banged up. My doctors were content to keep me on percocet till kingdom come, until I requested a prescription for something less…intense. I was prescribed Darvocet. Well, after taking it my heart rate shot up. I went to the ER and everyone insisted I was experiencing an anxiety attack. Every time I suggested then, and since that there could’ve been a correlation between the Darvocet and my symptoms, I’ve been laughed off, brushed off and told that there is no possible connection between the two. I am glad that the FDA is doing something about this. Lord knows drug companies won’t, and Doctors won’t consider it. To pain sufferers here, ask your doctor to try you out on Ultracet. It is a non narcotic pain reliever that works.

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