No More Darvon Or Darvocet For You

Two of the more commonly used painkillers in the U.S. have been pulled from the market by their manufacturer after a new study linked the drugs to potentially fatal heart rhythms.

The decision by Xanodyne Pharmaceuticals to pull the two drugs comes more than a year after regulators in the UK and the E.U. banned drugs using the same active ingredient, propoxyphene. The FDA has asked makers of generic versions of propoxyphene to stop selling the drug domestically.

According to the FDA, around 10 million people in the U.S. took some form of propoxyphene in 2009. Most of them were prescribed Darvocet, which combines propoxyphene with acetaminophen.

An FDA advisory panel had voted in 2009 to pull the drug, but the FDA opted to reject that recommendation. Instead, they launched a study into the potential cardiac effects of
propoxyphene.

The results of that study showed that the drug increases risks for heart arrhythmias even in healthy patients.

The FDA has urged doctors to stop prescribing propoxyphene immediately, but patients currently taking the drug should continue to use it while their doctors switch them to a different medication.

Darvon, Darvocet painkillers pulled from the U.S. market [L.A. Times]

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  1. wynterbourne says:

    Outstanding. My wife’s a liver transplantee with severe drug allergies, including one to codeine and codeine derivatives. Darvon, Darvocet, and Tylenol are about all she’s permitted to take.

    • hr4740 says:

      I have a similar problem. I’m not allergic, but my body just can’t tolerate the codeine or derivatives. Thanks FDA.

    • LuckyLady says:

      @Wynterbourne, sorry to hear this… would Ultracet work?

    • White Scorpion says:

      Codeine gives me horrible headaches so I always request Percodan for severe pain.

    • ReverendTed says:

      From what I’ve read (so, obviously, take this with a grain of salt), most of the pain relief from Darvocet comes from the acetaminophen (Tylenol) anyway, and the propoxyphene doesn’t really add any benefits, while increasing the risk of allergies and other adverse drug effects.
      It’s been suggested that Darvocet would never have gotten approval by the FDA if it were introduced today. It’s basically “grandfathered in” by virtue of having been used since the ’50s.
      The US is the latest in a growing list of countries that have banned or phased out Darvocet.
      As suggested by LuckyLady, it might be worthwhile to ask her physician about UltramUltracet.
      PercodanPercocet are pretty potent and carry a much higher dependency risk, especially for chronic use, so I tend to avoid them if possible.
      Honestly, she’d probably get the same level of pain relief from straight Tylenol as she would with the Darvocet. (I’m assuming she’s not permitted NSAIDS like ibuprofen?)

      • Purr says:

        The pain relief from Tylenol might be true with DarvoCET, but Darvon does not have Tylenol. Tylenol has been proven to increase pain in a lot of people. I’ve lived with chronic pain for a decade and Darvon is the only pain relief I’ve found. All others increase pain or do nothing at all. This is very sad news for me… and for my family who will witness it as much as I try to cover. Yes, Ive tried dozens of variations of high-level narcotics and other pain pills. Darvon is worth the risk, for me. I really wish I still had the choice.

    • Kibit says:

      Has she tried Dilaudid?

      My husband was given it when he had a Kidney Stone and it was the only thing that helped him. I know that your wife’s situation is completely different and I hope she is able to get any relief that she can. I just wanted to mention it in case she hasn’t had any experience with it before.

      Hydromorphone is the generic name
      http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000545

  2. Applekid ┬──┬ ノ( ゜-゜ノ) says:

    Fatal heart rhythms? I guess you could say I can’t feel the beat within my heart.

  3. Groanan says:

    All the more reason to legalize marijuana (and a half dozen narcotics).

  4. jessjj347 says:

    I wonder why the U.S. is over a year behind? I’m wondering if there was some incentive ($) to keep the drug on the market.

  5. the Persistent Sound of Sensationalism says:

    I thought the fact that most doctors avoid prescribing it because many patients complained about its ineffectiveness would be enough reason to pull it.

  6. chemmy says:

    Darvocet worked well for me when I needed it and nothing else worked.

    Not for nothing, but if something is on the market long enough and used by enough people, I’m sure that you can have any number of negative results.

    Not for nothing…. but I don’t see cigarettes pulled from the shelves due to a risk of lung cancer or death. AND you don’t even need a prescription. (I understand that cigarettes are noted to be dangerous but there is a risk in taking ANY drug).

    Alcohol causes a ton of deaths and it’s still legal.

    Noted on the whole marijuana issue.

    I wonder if people have ever had problems with codeine? Ehhhh I’m just ranting here. I hope it all makes sense.

    • Groanan says:

      It does.

      In similar news, earlier this year they wanted to tighten people’s access to Vicodin.
      Why? Because Vicodin contains acetaminophen (Tylenol) and if you take too much Vicodin, the Tylenol is toxic.

      So instead of having people in pain take Vicodin, they are suggesting that they go home and take Tylenol.

      • Megalomania says:

        That’s true, but you’re somewhat misrepresenting the issue. Vicodin is hydrocodone (an opiate) mixed with paracetamol. In the US, non-prescription tylenol is paracetamol only (tylenol 1/2/3/4 contain codeine, another opiate, but they are not OTC). The completely valid concern is that due to well known addictiveness of opiates, someone addicted to vicodin will overdose on the paracetamol and suffer liver damage or failure. Taking pure acetaminophen carries the same risk of overdose, but the risk of addiction is much smaller.

        The main solution that is proposed, insofar as I am aware, is generally that hydrocodone itself be prescribed instead. However, pure hydrocodone is a schedule II substance in the US, while as a combined substance it is schedule III, making it much easier to prescribe.

        At any rate, yes, acetaminophen is far more physiologically dangerous than most other painkillers, but as long as addiction is the only concern of lawmakers, it’s not going away in prescription painkillers any time soon.

        • Groanan says:

          The only problem I have with the validity of this change is that people who are seriously in pain will over self-prescribe the OTC Tylenol.

          My own personal experience has been that one Vicodin is far better at relieving tooth / tonsillectomy pain (kinda like a really bad strep throat) than 1000mg of Tylenol and 800mg of Motrin combined (which is what I’d take three times a day if not prescribed Vicodin).

          • HogwartsProfessor says:

            Hydrocodone works pretty good at pain relief, but BOY does it make me sleepy! I had to take it after I got my gallbladder out. It makes it so you can’t pee either!

            There were a couple of times after I took it that I felt a little “WHOOO” feeling, and I supposed that’s what people get addicted to. But it was so short-lived and the sleepy was so strong, I just fail to see how anyone could get hooked on it.

            Maybe the Percocet doesn’t do that? I don’t really want to find out.

            • Groanan says:

              Yeah, it really does put you down like a large Mexican dinner.
              I never felt addicted, but my only drug to compare this one to is caffeine, which if I stop cold turkey, gives me mind splintering headaches, nausea, and severe irritability for at least a week (and it takes about two months before I feel normal).

              And when I am not on caffeine, I unconsciously try to get back on it and have to stop myself (if I can in time) from gorging on chocolate, coffee cake, etc. Compared to caffeine hydrocodone is not addictive.

            • ReverendTed says:

              Percocet (oxycodone) even more potentially habit-forming than Vicodin (hydrocodone).

    • Jaynor says:

      Not for nothing, but someone is from New York.

  7. wonderkitty now has two dogs says:

    I guess it’s good then that Darvocet made me sick as all hell the first time it was prescribed to me. I’m still shocked at many doctors prescribe the drug, though.

  8. Megalomania says:

    What the FDA doesn’t mention is that the only reason that darvon (and darvocet, which I’ll get to in a minute) is used at all is that it’s a very weak opiate and thus has less likelihood for addiction. Which is all well and good, but due to it being so weak, patients have to take larger and larger doses… which leads to side effects like those mentioned above. This is because the US drug policy is so strongly against powerful opiates that it puts absolute priority on decreasing the likelihood for addiction.

    Darvocet (and percocet, vicodin, and your choice of other opiates that are combined with acetaminophen) had its own range of problems due to its acetaminophen – paracetamol to those outside the US – as it will cause liver damage when overused. Paracetamol, despite being a less effective analgesic than the majority of opiates, is used SPECIFICALLY because its negative side effects make addiction unlikely. Vicodin, for instance, is a schedule III drug under the CSA, but hydrocodone (the opiate it contains) is a schedule II. So yes, the government would rather you die of liver failure than become addicted to opiates.

    Paracetamol, incidentally, is what’s in tylenol, and why it’s a lot safer to take advil/motrin than tylenol if you’re taking OTC drugs for pain relief over more than a day or two.

  9. npage148 says:

    Darvocet has the analgesic effect equivalent to a standard dose of aspirin. It’s an ineffective drug with horrible side effects.

  10. jerrycomo says:

    Big Pharma is angry at losing two streams of income.

  11. BradenR says:

    Are we supposed to be gullible enough that we don’t get the concept of profit in this decision? Newer drugs cost three to four times as much and you can bet that figured into the reasoning. Darvon never killed anyone that a doctor was monitoring regularly, nor a patient who used the drug intelligently. My heart is just fine despite sporadic debilitating pain cycles. I never take the full doze prescribed and then for very short periods.

    • ReverendTed says:

      I don’t think there’s a conspiracy here. Darvocet is a 50-year-old drug that studies consistently show is no more effective than Tylenol alone.
      Most doctors I know only prescribed it when they were worried someone was a potential abuse risk.

  12. grumpygirl says:

    Interesting. I had not heard of the heart arrhythmias before. That explains a lot about my dad’s autopsy report (from 1988) and why his doctors & the coroner were so baffled about what happened to his heart when he died. Granted, he was heavily abusing Darvocet and had the requisite liver damage to show for it, but they could not understand why the paramedics had detected some serious heart arrhythmia just before his heart stopped on the way to the hospital. Much becomes clear. Thanks, Consumerist, for helping my family & me better understand a 20+ year mystery.

  13. banmojo says:

    1. 10 million darvocet users? At the local 3 nursing homes I visit, darvocet is listed as ‘prn’ on 90% of the charts.

    2. Every MD I’ve asked about this has stated emphatically that they will continue Rx’ing Darvocet as long as it’s available. We all have pts who’ve taken this for 10-15 years, with excellent results and no complications, and now one study puts the FDA up in arms about this?

    3. This is akin to the Mobic scare in the early 2000s. And now you can find PLENTY of Mobic users nationwide, and no one is talking about the link with cardiac disease anymore, and most of the law suits were fruitless. This will be the same, mark my words.

  14. Moderate Mel says:

    Hello, patent is just running out so the generics could be coming on line. So how do you taint a former brand and push people to the new name brand, by tainting the name Darvocet.

    Does anyone remember Seldane? It was the best hay fever brand out there until after 17 years it all of sudden causes heart problems. Manufacturer took it off market and there has been no lawsuits since no one ever got heatr problems from it. What replaced it.. Allrgra to the rescue with full 17 years more patent.

    Darvocet is at ene of patent so it’s now causing heart problems? Don’t believe it. The only problem is they can’t gouge for it anymore. FDA is a worthless. Leavitt from Utah is an idiot.

  15. lizza_sun says:

    Coming from the sun and near Mexico, I could get all the
    Darvon and Darvocet I wanted for my chronic back pain.
    I work for a living and the Darvon was the only thing that
    kept me functioning and able to work without being doped up.

    Now they have taken that away from me; maybe if all these do
    gooders had to live with pain, they would change their stories.

    I have been taking it for years without any bad effects.
    Fortunately, I found a place to get some, but can’t mention
    it on this website. .