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Thread: Propoxyphene Being Withdrawn From Market

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    Veteran Member mellowsong's Avatar
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    Default Propoxyphene Being Withdrawn From Market

    Propoxyphene Withdrawn From US Market
    Allison Gandey
    Posted: 11/19/2010

    New clinical data showing that the drug puts patients at risk for potentially serious or even fatal heart rhythm abnormalities has prompted regulators to act. An estimated 10 million patients have used these products.

    At a press conference today, John Jenkins, MD, director of the Office of New Drugs, said the new numbers tipped the risk–benefit ratio against the drug.

    The withdrawal will include brand name, generic, and all propoxyphene-containing products. "For the first time, we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart," said Gerald Dal Pan, MD, director of the Office of Surveillance and Epidemiology.

    The FDA is advising healthcare professionals stop prescribing propoxyphene. Patients who are currently taking the drug should not abruptly halt their medication but should contact their physician as soon as possible to discuss switching to another pain-management therapy.

    "Long-time users of the drug need to know that these changes to the heart's electrical activity are not cumulative," Dr. Dal Pan added. "Once patients stop taking propoxyphene, the risk will go away."

    Propoxyphene is an opioid typically used to treat mild to moderate pain. It was first approved by the FDA in 1957. It is sold by prescription under various names alone or in combination with acetaminophen. Since 1978, the FDA has received 2 requests to remove propoxyphene from the market.

    In January 2009, an FDA advisory committee voted 14 to 12 against the continued marketing of propoxyphene products. At that time, the committee called for additional information about the drug's cardiac effects.

    Withdrawal Already Underway in Europe

    A phased withdrawal of propoxyphene is already underway in Europe. The European Medicines Agency made that decision in June 2009. The FDA had considered a withdrawal last year but decided instead to allow continued marketing with a new boxed warning alerting patients and healthcare professionals of the risk for fatal overdose. The agency also required Xanodyne to conduct a new safety study assessing questions about the effects of propoxyphene on the heart.

    The results of this study, combined with new epidemiologic data and medical examiner reports, prompted this latest regulatory action.

    Should the FDA have acted sooner? Dr. Dal Pan told Medscape Medical News that regulators did not feel there was sufficient evidence before now. "The new information on the effects of the electrical activity on the heart was the final piece to the puzzle," he said.

    "These new heart data significantly alter propoxyphene's risk–benefit profile," Dr. Jenkins added. "The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks."

    http://www.medscape.com/viewarticle/732887

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    Veteran Member mellowsong's Avatar
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    Default Re: Propoxyphene Being Withdrawn From Market

    This is a very old drug and I really am skeptical about this data. Drug companies have wanted it gone for years because it is dirt cheap. If there really is a connection to dysrhythmia, then rather than totally withdraw it, put prescribing guidelines with it and have the patient sign something stating this risk has been explained. It is a good option for many people, bridging the gap between NSAIDS and stronger opioids such as morphine. It was also a very good option for those allergic to codeine and codeine derivatives. Sometimes pain medication is necessary such as after surgery or an injury or severe arthritis. Gritting your teeth and bearing it isn't alway feasible.

    Personally, I have episodes about once a year requiring something stronger than Aleve (such as a torn meniscus, dislocated hip, post surgery). On these occasions I take Darvocet or Darvon (with no acetaminophen in it). Without this as an option and being seriously allergic to codeine and its relatives and also sensitive to tramadol (Ultram) that leaves docs 2 options when I need something:
    1. Give me morphine
    2. Tell me to take Aleve and suffer.

    Knowing the current medical mindset regarding narcotics, I am well aware that invariably, option 2 will be chosen. I wish I had some stockpiled.
    Last edited by mellowsong; 11-19-10 at 04:03 PM.

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    Veteran Member Reesacat's Avatar
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    Default Re: Propoxyphene Being Withdrawn From Market

    I agree with Mellow-Propoxyphene (Darvon) has been around for a long time and something like this would have shown up before now. The only thing I can think of is that perhaps the Darvon is reacting with a new drug/chemical.
    I am one of the people that can't take most pain meds except Darvon if I really need something for a cracked rib, etc. and this would take away my choice for pain meds. Labeling the Darvon would make a lot more sense.

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    Veteran Member Samurai's Avatar
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    Default Re: Propoxyphene Being Withdrawn From Market

    Related to Darvocet?

  5. #5
    Veteran Member Reesacat's Avatar
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    Default Re: Propoxyphene Being Withdrawn From Market

    Quote Originally Posted by Samurai
    Related to Darvocet?
    Darvocet is Darvon+Tylenol (propoxyphene+acetaminophen)
    Last edited by Reesacat; 11-19-10 at 08:05 PM.

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