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Darvon and Darvocet Pulled From Market Over Heart Problems

10 comments

The makers of the popular prescription pain medications Darvon and Darvocent have agreed to voluntarily withdraw the drugs from the U.S. drug market, see the CNN article here.

The U.S. Food and Drug Administration (FDA) asked Xanodyne Pharmaceuticals to remove the drug from the market after a recent study showed that the medication could cause serious and potentially fatal heart rhythm abnormalities in some patients.

The FDA does not believe that that the pain reducing efficacy of the drug outweighs the potential risks involved with taking the medications. The FDA has also asked generic manufacturers to their products as well.

The FDA is urging patients currently taking Darvon, Darvocet or other generic versions of propoxyphene to consult with their physicians as soon as possible about switching to an alternative medication.

Propoxyphene was first approved for use by the FDA in 1957 to treat mild to moderate pain. Since 1978 the Administration has received two requests to remove the drug from the market, but concluded that the benefits of the drug outweighed any potential health risks each time.

Individuals who have suffered heart rhythm abnormalities and other heart problems while taking Darvocet, Darvon, or any other form of propoxyphene should contact with a drug recall attorney for a free consultation to discuss their legal rights.

10 Comments

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  1. Elizabeth Diamond says:
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    I have used Darvocet for pain relief fo years without any heart rhythm abnormalities. Being under a Drs. frenquent supervision any heart abnormalities would have been caught. Also being allergic to several medications this recall is going to limit my choice of pain medications.

  2. Quiet1 says:
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    I have taken Propoxyphene, the generic form of Darvocet, for several years without any side affects or heart related problems. I do suffer with chronic back pain. I have had a spinal fusion, surgery on both knees twice and now need knee replacements on both knees. I also have Multiple Sclerosis which adds to the problem and the pain. With that, my physican does monitor these problems and without this medication I basically could not function.

    I have always said that if a person has NEVER experienced back pain, and not the aches and pains from over doing it, but the pain that renders you immobile and keeps you flat out in bed because just getting up to go the bathroom or kitchen is extremely difficult, will never understand it. That includes sitting for any length of time, walking, and OMG don’t even think about bending over. And did you know that when your back pain is so bad that every time you drop something it falls on the floor?! Sure that sounds stupd, but not if you have ever experienced chronic back pain that you just start leaving the stuff on the floor and have someone else help you.

    There really wasn’t much information regarding the recall except it “could”, the operative word, cause heart related problems. They said a study had shown this problem. OK, how many people were involved, what was the age, how many were men and women? There are many factors that could cause this problem. Myself, I think they’re making a wrong decision. Other pain medication that is available is stronger than Darvocet. I have made an appointment with my physician to discuss my options and have been advised to continue my medication until then.

    It’s sad to see all the attorney advertisement, although expected, as soon as there is a drug with potential problems. They see it as mass law suits and money! We’ll see and hear an ad on TV, “if you or a loved one have taken the drug Darvocet and experienced heart related problems…call whatever attorney is running the ad, you may be eligible for compensation.” I trust my physician will have an appropriate suggestion for me and trust whatever they decided. I WILL NOT be calling any attorney. I’ve taken other medications that I have had severe reactions to. Should a patient call an attorney every time something doesn’t work?

    The comment regarding “Opiates do not manage chronic pain”, you are so wrong. Just as the “study” indicated a problem in some patients, not once did it say the pain medication was managing anything else but pain! Yes, there are some, a small percentage, that do abuse their prescriptions; however, it does not happen when you have a good physician that monitors your prescriptions. I can only refill my prescription once a month for the required amount and it must be a written prescription each month, there are NO refills. I am on Medicare due to my disability, let’s say even if I tried to, Medicare will only fill it once a month. If it happens to fall in the sink, which has happened to me, I could not refill it until the next month. You can hardly abuse it when you are given only 30 or 60 per month. By the time you get the “exception” forms filled out to Medicare for approval, it would be the next month anyway.

    There’s not much we can do as patients when a drug is taken off the market for whatever reason. As it relates to my MS, I initially had a prescription for Cylert to help with the fatigue and it was taken off the market for a similar reason. It took many months to find something that would work for me and I suffered dearly until then. It was replaced with Adderall. That’s just one example. It’s a pharmaceutical market, I’m certain there will be another drug to replace this one which will cost more and there’s not much we can do about it.

    Really there is only two ways to look at this, the minority that doesn’t have a clue about chronic pain and the majority that wishes they could experience it just one time! I can say with 100% certainty that the majority that suffers with chronic pain would gladly give it up and any pain medication for the occassional muscle aches or better yet resolution! And when there is none, we are grateful for the pain medication and have no problem overseeing the ignorance of those who do not understand.

  3. terri says:
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    Hello I am a 47 yr old female who has been on darvocett for many years. I’ve had pvc’s for several years now and because of this and my family has a strong history of CHF I’ve been checked regularly. They never found a problem until last year, at that time there was conflicting test results as to what my ejection fraction was, therefore, my Dr. did a heart cath and found that my ejection fraction was 17%. While they were in there I had illregular heart rythem which caused my dr. to put a defribulator in. I had checked out up until that year ok, I belive that the extended use of this medicine caused this. 5 months later my Mother had the same thing happen. Shes had to take this medicine because she is allergic to codine. So I say if you have this medicine DON’T take it anymore. I was just lucky I was in Operateing room when I had that bad spell, if not I probaly would not be here today

  4. Wow says:
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    I just turned 30 in November. In February of 2010, while I was 29 years old, I was rushed to the emergency room for heart complications. After extensive testing, they found that I had a SupraVentricular Heart Arrythmia and palpatations. In September of 2010, I was rushed to the same emergency room for a TIA (basically a mini-stroke). I’m also an active male who has gotten many bangs and bruises over the years and my drug of choice was Darvocet. I’m 30 years old and I take the same heart medication my 86 year old grandmother takes. And I have a serious heart arrythmia. Thank you to the makers of Darvocet.

  5. Dr Ulf Jonasson says:
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    Dear Sirs,

    We want to add to this text that we have studied the painkilling substance propoxyphene (DXP) since 1993. Now FDA says that ONE NEW STUDY made them to stop Darvon. We have informed FDA about our research since 1999-2000, they know about our 9-10 scientific articles about the substance, we also wrote two doctorial dissertations (2000 and 2001) in Sweden.

    Our research was behind the decision in UK, Sweden and The European Union (EU) to stop the drug. Go to this link, http://qjmed.oxfordjournals.org/content/98/3/159.2.full

    Our references are nrs 21-26.

    Ulf Jonasson, Doctor of Public Health Birgitta Jonasson, PhD

    Search Jonasson Propoxyphene

    ulf.jonasson@telia.com

    Go to YouTube, Darvon, Distalgeic and Co-Proxamol. The worst drugs ever

    http://www.youtube.com/watch?v=q92lL4kM-JE

  6. Dr Ulf Jonasson says:
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    Dear Sirs,

    We want to add to this text that we have studied the painkilling substance propoxyphene (DXP) since 1993. Now FDA says that ONE NEW STUDY made them to stop Darvon. We have informed FDA about our research since 1999-2000, they know about our 9-10 scientific articles about the substance, we also wrote two doctorial dissertations (2000 and 2001) in Sweden.

    Our research was behind the decision in UK, Sweden and The European Union (EU) to stop the drug. Go to this link, http://qjmed.oxfordjournals.org/content/98/3/159.2.full

    Our references are nrs 21-26.

    Ulf Jonasson, Doctor of Public Health Birgitta Jonasson, PhD

    Search Jonasson Propoxyphene

    ulf.jonasson@telia.com

    Go to YouTube, Darvon, Distalgeic and Co-Proxamol. The worst drugs ever

    http://www.youtube.com/watch?v=q92lL4kM-JE

  7. jeff says:
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    The risk for potential heart attack and die to me is less then the current pain I am in. In fact it is horriable right now, without taking my darvocet and trying other forms ultracet so far have been completely ineffective. I am now not able to sleep and I can’t keep my muscles from spassing. The ONLY thing to ever give me temporally relief was this medication. They just killed me by taking this off the market.

    I am now at risk of losing my job and my other activities because I can’t sleep.. my life is about to be over.

  8. Helen says:
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    Now what do I do? I have taken Darvocet for years for severe arthritis in the knees! I just recently had a gastric bypass so Ibupropen is OUT as is aspirin and any other paid meds that cause stomach problems!

    And Tylenol…even extra strength…does NOT work!

    I am allergic to Morphine so Percocet is OUT also!

    I suppose I could go to Oxycodone but honestly I’d rather not. Darvocet gave me NO side effects but it took away the pain within 20 minutes and it stayed gone for at least 8 hours!

    UGH… I do NOT want to go to a more severe/stronger pain medication!

  9. Helen says:
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    Now what do I do? I have taken Darvocet for years for severe arthritis in the knees! I just recently had a gastric bypass so Ibupropen is OUT as is aspirin and any other paid meds that cause stomach problems!

    And Tylenol…even extra strength…does NOT work!

    I am allergic to Morphine so Percocet is OUT also!

    I suppose I could go to Oxycodone but honestly I’d rather not. Darvocet gave me NO side effects but it took away the pain within 20 minutes and it stayed gone for at least 8 hours!

    UGH… I do NOT want to go to a more severe/stronger pain medication!

  10. Deb says:
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    Last July I ended up in the ER after suffering a heart attack. After a 5 day hospital stay full of tests my doctor and I were both wondering what made an otherwise healthy 41 year old female have a heart attack. I have good cholesterol and triglyceride levels, low blood pressure and no blockages. After a year of wondering I finally have my answer. Fortunately for me I never took the Darvocet daily like my doctor had prescribed and only took it when over the counter meds and massage and exercise didn’t help. However, the month of my heart attack I was moving so I was taking the Darvocet at regular intervals. I am convinced that the medication caused my heart attack.