Public Citizen Petitions FDA to Ban Darvon Products

Discussion in 'Fibromyalgia Main Forum' started by JLH, Jun 4, 2006.

  1. JLH

    JLH New Member

    Public Citizen Petitions FDA to Ban Darvon Products

    Prescription Painkiller Causes Many Fatalities; Petition Filed with FDA


    Public Citizen today petitioned the U.S. Food and Drug Administration (FDA) to immediately begin to phase out the widely prescribed pain reliever propoxyphene (Darvon, Darvocet and generic versions) from the market because the drug has been associated with more than 2,000 accidental deaths, is physically addictive and is no more effective than safer alternatives.

    Data from the Federal Drug Abuse Warning Network, which provides autopsy information from medical examiners in the United States, has found that 5.6 percent of all drug-related deaths were related to propoxyphene during the past 19 years. In 2004, 23 million prescriptions for propoxyphene were filled, making it the 12th most commonly prescribed generic drug in the United States. Four companies account for more than 91 percent of U.S. prescriptions.

    Propoxyphene has been associated with 2,110 reported accidental deaths in the United States since 1981. A large proportion of these deaths occur 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, resulting in cardiac depression. 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.

    “The number of deaths involving propoxyphene in the U.S. alone is striking,” says the petition, filed by Public Citizen and two Swedish experts on propoxyphene, Drs. Ulf and Birgitta Jonasson. The entire petition can be viewed at

    Last year, the British government announced a phased withdrawal of the drug because of its negligible effectiveness and the high risk of overdose and death. “It has not been possible to identify any patient group in whom the risk-benefit [ratio] may be positive,” the British government stated.

    In addition, popoxyphene has been deemed inappropriate for prescription for the elderly because of central nervous system-related adverse events – such as sedation and confusion – that have been found to increase the likelihood of falls and fall-related fractures in the elderly. Studies have shown that propoxyphene use is widespread in the institutionalized population, in emergency rooms and in community-dwelling older people, populations in whom propoxyphene is most dangerous.

    Public Citizen is calling for the drug to be phased out, rather than banned immediately, because of its addictive quality.

    “The Food the Drug Administration should immediately begin phasing out the use of propoxyphene,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “Millions of people, many of them elderly, are being put at risk when using this drug when there are safer, more effective alternatives available. We agree with the British government’s conclusion that the efficacy of this product ‘is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable.’ ”

    Public Citizen has a strong track record of identifying dangerous drugs well before federal regulators take action to ban or put warnings on these drugs. For example, Public Citizen warned consumers about the dangers of Vioxx, ephedra, Bextra, Rezulin, Baycol, Propulsid and many other drugs years before the drugs were pulled from the market.

    SOURCE: American Academy of Pain Management

  2. ilovecats94

    ilovecats94 New Member

    I had no idea that the FDA was trying to ban Darvon products. I was one who was on Propulsid from 1993 to the time they banned it, which I really can't remember now.

    I never thought it would be dangerous like that. Kind of glad they did ban it because it was making my FMS worse. So I know I was on it after 1995. Now I'm back on the Reglan.

    I don't really know of anyone who uses Darvocets that say they help their pain.


  3. SPR30

    SPR30 New Member

    Darvocet is one of the first pain meds many docs try for chronic pain and pain with surgery, is one of the most often prescibed pain meds, percocet too. (here where I am, central FL)
    Used to seem that Tylenol 3 was popular.
    Darvocet isn't strong enough to help many of us here, you rarely hear anyone here taking it.(by here I mean people with FM and RA, OA.
    I used to take it a few years ago, but quickly found out is wasn't strong enough, not Darvon or Darvocet.
    I am curious to see what becomes of this, keep us posted.

    [This Message was Edited on 06/07/2006]
  4. claudiaw

    claudiaw New Member

    and have for about 4 yrs. it no longer does much for me.

    i asked for something stronger and my Rhuemy acted like he did not really want to give anything stronger, but I get terrible migraine like headaches that darvocet does nothing for.

    he gave me Loratab that doesn't do much either.

    I don't know what to do now.

    [This Message was Edited on 06/07/2006]
  5. pam112361

    pam112361 New Member

    This is what my rheumy was telling me about at my last appointment. He insists that narcotics don't help the pain of fibro, but I have to disagree. If I take a darvocet and 2 ultracet, I have a definite drop in my pain level; at least enough to get me through a work day.

  6. JLH

    JLH New Member

    Darvocet was the very first pain med that I tried.

    It didn't do anything more than Tylenol did for me.

    Just wanted to give everyone on Darvon or Darvocet a heads up!!


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