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Michael Roberts
Michael Roberts
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FDA Request for Withdrawal of Darvon and Darvocet May Have Come Too Late

16 comments

Darvon and Darvocet Recall
Failing to remove a dangerous product from the market can have severe health consequences. But it is even worse when the withdrawal effort could have come much sooner and some of the health issues prevented. Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, recently agreed to withdraw the medication from the U.S. market. The withdrawal came at the request of the FDA. The FDA sought withdrawal of propoxyphene after the agency received new clinical data that showed that propoxyphene-based drugs puts patients at risk of potentially serious or even fatal heart arrhythmia. After weighing the benefits and risks of the drug, the FDA determined that the serious heart risks, combined with the risks of suicide, addiction and death outweighed the potential benefits of the drug as a painkiller. However, despite the FDA’s decision to request the withdrawal at this time, the consumer watchdog Public Citizen blasted the FDA for waiting too long before issuing a Darvon and Darvocet recall late last week.

Earlier Complaints Ignored
Propoxyphene, which is contained in Darvon and Darvocet, is an opioid used to treat mild to moderate pain. Darvon was first introduced in 1957. Now, the drug is most commonly prescribed as Darvocet, which combines the active ingredient in Darvon with acetaminophen, the active ingredient in Tylenol. Darvocet’s use is not limited to a small number of people. In fact, it has been prescribed for more than 22 million people and is one of the 25 most commonly used prescriptions.

The widespread use makes the FDA’s slow reaction time even more devastating. Public Citizen released a statement this past Friday stating that the delay may have resulted in 1,000 to 2,000 additional Darvon and Darvocet deaths during the years after the FDA should have recalled all propoxyphene drugs. Public Citizen first petitioned the FDA for a Darvocet and Darvon recall in 1978. At that time, there was already evidence of the adverse health effects Darvon and Darvocet could have on the heart. But the earlier warnings did not end there. The U.K. decided to pull Darvocet and Darvon from that market in January 2005, after determining the drugs were too dangerous and had little benefit. Public Citizen petitioned the FDA for a recall again in 2006, but again to no avail. It then filed a lawsuit against the FDA in 2008 following the FDA’s refusal to act on its petition.

FDA’s Response
It was not until after that lawsuit that the FDA’s own advisory committee voted for a recall in January 2009 for the same reasons as the UK. The FDA defended its decision to wait however, saying that it only recently received enough data to justify that the risks of Darvon and Darvocet side effects outweighed its health benefits.

What the Future Holds
There is a small bright spot for some patients. “With the new study results, 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, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.”

Dr. Sidney Wolfe, director of Public Interest’s health research wing, wasn’t focusing on the limited bright side and instead had some harsh words for the FDA. “Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since [the] time the UK ban was announced,” Wolfe said. “The FDA’s pitiful excuse that it needed to order a human study to find that ‘the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities’ before deciding whether to ban propoxyphene only emphasizes how out-of-step the agency is with the rest of the world – which already had enough human evidence of death and near-death in tens of thousands of people to act accordingly.”

Conclusion
Consumers who have been harmed by Darvon or Darvocet should not just accept their health issues. Whether or not the FDA or Xanodyne acted negligently remains to be determined. Public Citizen has called for a congressional investigation into the agency’s negligence, but patients should not wait for the results of that potential investigation. The time to contact a lawyer and explore all potential remedies is now.

16 Comments

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  1. jay says:
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    This is all BS, Darvon was a good medication with no side effects. It worked and harmed no one. There was a huge price increase ($242.00) for 30 supply. Insurance companies won’t pay for it. That’s where the problem lies. The insurance companies own this Government.

  2. Rose says:
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    Ihave used darvocet for years for chronic back pain after surgery and it has worked better with none of the serious side effects of fentanyl, vicodin or several others that I have tried. Where does that leave people like me who have really benefited from the use of darvocet?

  3. Rose says:
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    Ihave used darvocet for years for chronic back pain after surgery and it has worked better with none of the serious side effects of fentanyl, vicodin or several others that I have tried. Where does that leave people like me who have really benefited from the use of darvocet?

  4. Terence Mix says:
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    The FDA’s decision to order Darvon and other propoxyphene-containing products removed from the market on November 19, 2010, comes 5 YEARS after the pain reliever had been banned in Great Britain and a YEAR AND A HALF after it was withdrawn by all other members of the European Union. While other countries were taking strong regulatory steps to protect their citizens, the FDA’s reaction had been to simply increase the warnings on its risks. Darvon and its sister drugs have had a long history of drug addiction, suicide and cardiac problems since first entering the market in 1957. My question is this – why should it take 53 years to determine that a drug should not be on the market?

    This history is not unique. On October 8, 2010, the FDA announced that Abbott Laboratories would be withdrawing Meridia from the American market, 9 months after the weight-loss drug was removed by the European Union. Earlier, the FDA had only strengthened the warning on the drug’s labeling, cautioning its users about the risk of heart attacks and strokes. On September 23, 2010, the FDA decided to allow Avandia to remain on the market, while the European Medicines Agency decided to pull the plug on the drug in Europe. These decisions are somewhat reminiscent of the history involving the drug, Cylert, which was withdrawn by the FDA in 2005 because it was causing severe liver damage to children taking it for ADHD – eight years after it was withdrawn by Great Britain.

    This pattern of increasing warnings while other countries are removing drugs that do not belong on the market is only a small sample of why our FDA and its oversight of drugs is no longer the gold standard of the world. Meanwhile, thousands of Americans are dying unnecessarily. As many as 230,000 per year die in the United States as a result of an adverse reaction to prescription and/or nonprescription drugs – a number that can be cut in half.

    Changes need to be made and they need to happen now. And it has got to start by eliminating the insanity of drug companies conducting their own premarket studies rather than an impartial entity, such as the National Institutes of Health. For everyone who is in agreement with taking some action, I would urge you to go to the website, http://www.FDAreformpetition.com and sign my petition to Congress demanding a change. Only if the citizens of this country speak in a strong and unified voice will we catch the attention of Congress and impress upon it the need for such a change.

  5. Oregonian says:
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    I do not support the recall of Darvocet from the market at all. I can find no published statistics that Darvocet has caused any more harm to patients then any other medication on the market. Darvocet worked for me every day of the past 10 years. If I was feeling good I could take less medication without effect. My life has been miserable since it was pulled off the market. First came the disabling withdrawals. Then the new pain medication caused all sorts of side effects (insomnia and dangerously high blood pressure) so they gave me meds to counter that, which have side effects of their own and kept me stuck in bed all the time. On to yet another pain medication and more side effects and on and on. I could live my life with Darvocet, happy and healthy but now I am home bound suffering one life threatening side effect after another and instead of taking 1 or 2 Darvocet and living my life I have to take 3, 4, 5 different pills. How could this possibly be better or safer for the patients??? It isn’t!

  6. Anonymous says:
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    I read this on another website: 93 percent of all propoxyphene-related deaths are the result of interactions with other drugs — more than half involving alcohol or diazepam. Overdose (mis-use and abuse) of Darvocet causes more injuries or deaths then when the medication is used as prescribed……. ANY medication can (and many are) just as bad if not worse then Darvocet, so why are they recalling Darvocet and not more dangerous drugs that have the same potential to harm when misused, such as Methedone or Ultram or Morphine?…. It is about MONEY & power, NOT patient care and safety.

  7. Where's their proof? says:
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    I read this on another website: 93 percent of all propoxyphene-related deaths are the result of interactions with other drugs — more than half involving alcohol or diazepam. Overdose (mis-use and abuse) of Darvocet causes more injuries or deaths then when the medication is used as prescribed……. ANY medication can (and many are) just as bad if not worse then Darvocet, so why are they recalling Darvocet and not more dangerous drugs that have the same potential to harm when misused, such as Methedone or Ultram or Morphine?…. It is about MONEY & power, NOT patient care and safety.

  8. Michelle says:
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    I know there are alot of outraged chronic pain patients that are left scratching their heads (myself included) How can a medication go from safe to take every 6 hours one day to recalled the next . This medication has been on the market for years and it JUST NOW started causing problems ?

  9. Jim S says:
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    I have used this medication for around 30 years, after my back was broken. Wish I could have used more powerful pain killers but have severe allergies to ALL other pain medications. So I have suffered quite a bit because darvocet was not strong enough for my pain, but was all I had. Now I will not have anything, and if I considered suicide before due to pain, well now my death will be almost guaranteed, bye all.

  10. sherylanderson says:
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    Ive taken Darvocet for 22 years for pain. Its the only pain killer that i have tried that actually took the edge off the pain and i was still able to function the other drugs put me to sleep. now what????????

  11. Diane R says:
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    I just found out about this yesterday and I am shocked. What is this country coming to? How can they just ‘yank’ this medication off the shelves overnight? I have been taking Darvocet for years for back pain and now I have to go through withdrawal? And then have a life of pain.
    Doctors are afraid to prescribe vicodin for fear they will be put out of they practices! Now this!??! This is BS and I don’t this any of us should thake this lying down!
    What IS NEXT?

  12. a name says:
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    REPLY TO JIM S.
    You are a selfish sob to make such a statement or think such a thing if you have 1 single person in this world who knows you because your suicide will cause them pain. At the very least, if your going to kill yourself disappear or do it at the coroners office some no one has to mentally suffer finding your dead body somewhere. Signed a fellow pain sufferer who will not be taking the easy way out!

  13. sue says:
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    I have also chronic back pain due to disk and RA. Darvocet has been the only thing I have been able to take for years that eases the pain and allows me to work for a living. The other RA drugs scare me to death and actually WILL kill you. Read the small print on some of these new drugs. TB ? Fatal infections? Hepetitis? Are they kidding? I have had nothing but horrible side effects to everything they have tried to give me. Why cant existing patient be allowed to continue with darvocet? Grandfather us in. We know the risks and would all sign off on lawsuits if thats the real issue. Chantix causes suicidal thoughts but thats ok. Viagra can cause 24 hr erections but thats ok. What is this really about? Will the FDA support me when I no longer can work? Should I file for disability now? This is all nonsense.

  14. Jim S says:
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    REPLY TO A NAME:
    Last relative died over 20 years ago, and no I have not a single friend, hard to have friends when you don;t get out. Back was broken twice as well as neck in a 7 car pileup.
    Everyone dies sooner or later, and their body is found by someone. If I was able to get to a coroner’s office they would stop any attempt at suicide in this state. Doc just tried me on Tramadol and had severe chest pains, even after wearing off my chest feels like it is a massive bruise.Other pain medication has always caused severe and almost fatal allergic reactions, there is NO doubt that if I keep trying new medications, they will eventually kill me anyway.I have no options left! I am betting that others will also die, funny this is happening when insurance and health care has been cut drastically, especially in our state. I had some friends last year, but every one of them died, well maybe they were more acquaintances met at various medical treatment facilities, know several of them died from fully treatable illnesses, but the treatments were either not available or too late.
    Thanks for reminding me I have no one that cares.

  15. Cheryl says:
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    Thanks soo much for removing one of the best drugs that treated my back and leg problems. Now, I have nothing at all. No quality of life. Suicide looks soo much better than chronic pain. All drugs have bad side affects. Why all of a sudden this one? My doctor wont prescribe any thing else that even half way works. Count the number of suicides compared to art. fib. It will surprise you.

  16. Cheryl says:
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    Thanks soo much for removing one of the best drugs that treated my back and leg problems. Now, I have nothing at all. No quality of life. Suicide looks soo much better than chronic pain. All drugs have bad side affects. Why all of a sudden this one? My doctor wont prescribe any thing else that even half way works. Count the number of suicides compared to art. fib. It will surprise you. This really sucks!!