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Darvon and Darvocet Deaths Lead FDA Panel to Recommend Recall

Harvey Kirk

UPDATE NOVEMBER 2010: Nearly two years after this recommendation, the FDA announced the recall of Darvocet and Darvon on 11/19/2010, indicating that data now links the medications to a potential risk of heart arrythmias, in addition to other side effects, such as suicide, overdose and death. The lawyers at Saiontz & Kirk, P.A. are reviewing potential Darvocet lawsuits and Darvon lawsuits for individuals who may be entitled to compensation for an injury or death.

Last week, an FDA advisory panel voted to recommend that a recall of Darvon and Darvocet be issued due to the risk of death, overdose and addiction, outweighing the eminimal benefits provided by the drugs over other available painkillers.

The drugs were banned in the U.K. in 2005, and the consumer group Public Citizen filed a petition with the FDA back in 2006 asking that the drugs be removed from the market. While the FDA is not required to follow the advice of their advisory panel, they usually do.

According to Public Citizen, between 1981 and 1999, there were over 2,110 Darvon or Darvocet deaths reported and the painkillers accounted for 5.6% of all drug deaths during that time.

Darvon and Darvocet both contain propoxyphene, which is used to treat mild to moderate post surgical pain. However, side effects of Darvon could include overdose death, suicide, addiction and other potentially life-threatening problems. In addition, the drugs carry little, if any, benefits over other safer forms of pain medication.

According to testimony before the FDA panel from Sidney Wolfe, M.D., Director of the Health Research Group at Public Citizen:

There is little doubt that were propoxyphene (Darvon) and propoxyphene-containing (Darvocet) products to come before these committees today for approval, based on what is now known, they would be rejected because of one of the most unfavorable benefit-to-risk ratios ever seen for a drug. This is not to say that there was insufficient evidence for a ban 30 years ago when we first petitioned the Food and Drug Administration (FDA) to withdraw the approval. But the forceful and successful war then waged by Lilly in opposition to such a ban tended to drown out evidence of minimal benefit and rapidly growing evidence of life-threatening, often lethal harm.

The deaths from Darvocet and Darvon are often caused because the drug is converted into a metabolite that is toxic to the heart and lasts longer in the body, potentially causing cardiac depression. It has also been associated with suicides, intentional and unintentional overdoses.

DARVON AND DARVOCET LAWYERS

The Darvon and Darvocet lawyers at Saiontz & Kirk, P.A. are evaluating the potential for lawsuits on behalf of people who have died as a result of using the painkiller drugs. If a friend or family member have suffered problems which may have been caused by Darvon or Darvocet side effects, request a free consultation and claim evaluation.

Posted in Darvocet | 38 Comments »

38 Comments Add Your Comments

  1. i cannot believe that this drug will be taken off the market. i hve taken this drug ( first Darvon and then darvocet) for at least 45 yrs. it is the only pain killer that I can take without causing problems to my stomach due to other illness. If there is anyway we can petition for this drug to stay on the market. I would certainly sign immediately.

  2. I was on darvocet in August 2008 and while I was on it I suffered seizures, hallucinations, and attempted suicide 3 times. I went after my husband with a steak knife and constantly provoked him to kill me because I did not want to live the way I was going through the things I was going through. I am currently off the darvocet and I am no longer suicidal or hallucinating. I am actually living a normal life again !!!

  3. Can someone tell me what amount of Darvocet it would take to be a lethal dose? Recently, a friend of mine intentionally overdosed. He actually took a mixture of Darvocet, Tramadol and Flexeril. He didn’t take a fist full at one time but did it over a 3 to 4 hour period. The Darvocet were the 100/650 dosage. The Tramadol were 50mg each and the Flexeril wer 5 mg each. It was determined that no less than 20 Darvocet, no less than 20 Tramadol and a dozen or so Flexeril had been ingested. He is a 245 lb man. No alcohol or any other drugs were taken. Fortunately his wife found him and called 911. I’m asking since I see this article mentions the fact people use this drug to commit suicide.

  4. Kristine says:

    I’ve taken Darvocet for 8 years for pain with migraine. It is the only drug I can take for pain that does not upset my digestive system. Why is it that because someone abuses a drug, the rest of us that are responsible, are adversely affected.

  5. I don’t believe Darvocet or Darvon should be takenn off the market. All drugs have potential side effects and most narcotics can cause dependency. Hydrocodone (Lortab, Vicoden, Norco) is far more potentionally addictive and has greater side effects than Propoxyphene.
    I have been a nurse for 22 years and have heard doctors and nurses call Darvocet “glorified Tylenol”. So why have they suddenly decided it’s too dangerous to keep on the market? I am allergic to hydrocodone and codeine and take Darvocet for moderate to severe pain because of nerve damage in my feet and legs due to 30 plus years of diabetes. The pain is not severe enough to need drugs such as oxycodone, dilaudid or morphine and since I cannot take hydrocodone, darvocet is my only option. Taken responsibly, most medications are not dangerous or lethal to the majority of the population. Only 5.6% of drug deaths in an 8 year period was caused by Darvocet/Darvon. What about the other 94.4% of drug related deaths? What drugs were the culprits in those deaths and why are they not being recalled?

  6. the tylenol is the problem. After 40 yrs of migraines, Darvon n-100 is an excellent alternative to having to take hydrocodone for moderate pain. Those that say it is no more effective than otc meds have an agenda. I find that when taken as directed, Darvon is an excellent tool and more effective than the NASIDs that are offered. Don’t take away my tools to lead a normal life whilst having migraine issues at hand.
    Tylenol with darvocet is far more dangerous for the kidneys and one should only take Darvon 100- N-100 w/o tylenol. It won’t tear up your stomach and you don’t have to go to stronger hydrocodone and it works well with immitrex type of meds.

  7. I’ve been taking Darvocet for several years to combat muscle pain as well as foot pain from nerve damage. The only drug I can take is Darvocet due to allergic reactions and stomach pain from other meds. I have tried OTCs as well as other narcotics, but they simply don’t touch my pain.
    I don’t understand why Darvocet should be taken off the market. It’s bad enough that I’m chronically ill and can’t drive on the days that I take Darvocet. But without Darvocet I would lose a number of days each month that could have been productive with it. Why should I and others like me be punished because some people aren’t judicious in their dosing?
    Perhaps a better choice would be to make Darvocet a controlled substance as has been done with ADD/ADHD meds. That way doctors could better oversee their patients’ usage.

  8. I am very concerned about this. I have been taking Darvocet for migraine pain along with Amerge for about 4 years. It is a magical combination for my pain. I never have to take more than 1 500mg and it works within an hour of ingestion. I will not move up to a stronger pain medicine due to the fact that I drive a school bus and I would have to miss work. OTC medications usually do not work. What are my options???? I get almost daily migraines.

  9. I have used Darvocet for years for back pain. It is the only pain medication that gives me relief without causing the somnolence of the narcotic pain relievers.

  10. Wish I could sue because they are removing this medication, this would leave me with more pain than I can bear. I have been informed in last few minutes that this medication will stil be available overseas. So my choice may end up being liberty or death, thought this was what the US was founded on. Shame.

  11. I have used Darvocet for the past three years due to a herniated disc in my back. It is the only pain medication I can take that does not make me nauseous and that does not cause problems with my stomach. I am allergic to hydrocodone and codeine and take Darvocet for moderate to severe pain I have heard Darvocet called “glorified Tylenol”. So why have they suddenly decided it’s too dangerous to keep on the market? Why is it that because someone abuses a drug, the rest of us have to suffer. Every drug has side effects, but the benefits usually outweigh the side effects. What can we do to keep this drug on the market?

  12. THE UK have lots of nerve to post anything about Darvocet and Darvon when they SELL OVER THE COUNTER WITHOUT A DOCTORS PERSCRIPTION: Packets of the medicines, which include Nurofen Plus and Solpadeine Plus (LOOK UP THE CONTEST OF THOSE DRUGS) They have codene like similar properties. Read up on the suicidal rate on their over the counter meds!! This is all crazy nonscense. If you are going to BAN darvocet..They might as well ban every single drug out there. Have you watched any tv commericials lately on the side effects of most drugs?? It makes you not want to take anything. Let’s get Real..Leave darvocet on the market. It’s been here for 50 years!!

  13. I take Darvocet for Migraines and fibromyalgia along with neurotin. If I can’t get darvocet anymore I don’t know what I would do. I have constant pain and can’t take percocet vicodin or delaudid. The pain would be unbearable, please don’t take darvocet off the market.

  14. I am an 85 year old retired surgeon who has prescribed darvon in my medical practice of 50 years. I can recall only one patient who was addicted to it. I have never seen a death. Currently I am anti-coagulated because of Atrial Fib. For that reason I cannot take non-steroidal meds that are effective for me. I take one or two darvosets per day for old age body aches. It is effective. To say it is no more effective than tylenol is a ferry tale. To take it off the market is rediculous. The FDA panel needs to focus on more important abuses that abound instead of such trivia.

  15. My wife passed away on oct 21st,2010….from an apparent accidental overdose of darvocet…i think if this a real and present danger….they should be taken off the market

  16. This is insane to take a drug off the market becauuse a few mis use it. Every drug has side effects. Adults should be responsible and know how to take their medication. Those who don’t should be locked up in the “psych” ward and their drugs can be monitored. I have a “deadly” heart problem that limits what medications I can take, so taking away darvocet which is only medication I can take for migraines leaves me NO alternative. I have 7 children, 2 with medically disabilities, I need to be able to function and won’t be able to with migraines. Only in COMMUNIST USA could thsi happen, take away something that peopel need. Keep raising health care cost, taking away health care plans that your doctor does not accept and now take away a medication that helps so many.

  17. i feel your pain. my back is full of arthritis and if i can not take it i willnot be able to work as i also can not take the other drugs because of problems with my digestive system. i am in tears. i will not be able to stand the severe pain i can hardly tolerate when taking darvocet. they are going to force more people on disability. this is insane. all drugs can be overdosed and cause lots of side effects. why are they punishing us like this. not fair.

  18. I want all the users of this medication to know that my best friend has been on this medication (Darvoct) for 25yrs. In the past 2 years she has been having seizers 2 -3 per week. Cronic stomach problems. She has been in and out of the hospital over the past year. Doctors have not given her a diagnosis. But, still prescribing her darvoct. Two wks. ago she almost lost her live due to extremely high heart rate during one of the seizers. Upon discards the doctors increased the dosage is darvocet changed the seizer medication.Told her she should be find now.All this to say she is having a seizure at this very moment…I’m scard of what’s going to happen next. Users please listen to your own body, if u think theres a proble plz seek medical attention. It could be deadly.And no she does not abue this medication, always had alot let over when it should be refilled. At least now we possiby know what her medical problems stem from…Best of luck to all patients currently or previosly used this drug. Sincerly,Concerned Medical Office Manager

  19. I have been through the ringer when it comes to pain. I’m 30 and have rheumatoid arthritis, have had 6 ankle surgeries, both shoulders come out of the socket, a slipped disc in my lower back and have suffered from migraines for over 15 years. So..!! I’ve been put on this and that, went through a horrible drawn out addiction to Vicodin for a few years. Now with the RA, I’m in pain quite a bit. My doc put me on the Darvocet 4 times a day as needed for the last couple months. Who knows how or why, but I was never addicted to them, never abused them. I have issues with other pain meds: tylenol 3 makes me itch and gives me a headache, I don’t want to touch vicodin ever again and go through what I struggled to overcome, ultram hurts my stomach even with food, and because of blood pressure elevation cannot take anti inflammatory meds. Anyone out there with the migraine issues – please try Fiorcet. It works wonderfully for mine. It’s got tylenol, caffeine, and butalbital (sp?) in it. That combo knocks my migraines out, so there’s hope for that! But I’m just wondering what options we all have for pain control with something that actually works, but something a bit stronger than OTC meds. And seems from reading the above comments that a lot of us can’t just jump from one med to the next. It’s like we have 2 options: take some OTC med that has no effect and still suffer, or be incapacitated and risk addiction and dependence with the stronger stuff…Im just so angry at this, as darvocet was strong enough without feeling loopy and addiction potential. Hope all these multi billion pharmaceutical companies will come up with something fast as a close replacement. Hope everyone figures something out, best of luck to all!!

  20. I have been taking Darvacet for about 15 years for chronic back pain.
    I have had no heart problems or suicidal tendencies. There are no other medications that are comparable to Darvacet. All other medications are stronger, that fact alone leaves more potential for addiction and overdose than Darvacet. The FDA really needs to think about this fact!!!

  21. Thankfully I refilled my Darvocet prescription on November 19th, the same day the recall was announced. This is the most effective medication I have taken for treatment of pain from a neck injury I sustained in an MVA, not to mention headaches. This is very disappointing news.

  22. I have had surgery on both lungs to have tumors removed, most all were inoperable. They continue to grow I size an number. I have chronic pain!! I’m on methadone for pain an Was on darvosets to take in between pills. I started having severe heart problems, my dr. Admitted me to the hosiotal an they decided to stop the Darvosets- my heart problems stopped that night! Thank God we caught it before It was Fatal!! A few yrs ago I met my Now husband, he was on darvosets-I DID NOT know this when we 1st began dating- One day he got scared telling me to feel his chest- his heart was beating so fast and hard, just as mine had done!! I. 1st started towards the ER I then ask what kind of meds did he take he replied “only darvosets” an I immediatly had a flash back as to what they did to me! Well I got him to the ER with only moments to spare, the Dr.’S said 5more minutes would of been to late!! OF course he was taken off the darvosets an put on something different, he’s not had any trouble again!! AN he was noT ABUSING the medicine, neither was I! True that a lot of pain meds lead to death, but those are almost always because of Abuse!! THE FDA had to have a lot of high numbers of people that have Never mis-used the drug for them to pull it off the market!! I know my husband an I both were almost among those numbers!!

  23. Most recently have been sporatically on the drug for 2 years (broken wrist/hand), then months later a concusion (CT & MRI cleared the head injury)…. Since then I’ve lost all focus, am dizzy & disoriented, weakness until I drop to the floor & cannot get up for hours, I even fall off my chair at my desk. Went to Baylor ER hospital last March for chest pains and could not not breathe, they did not even do an EKG & said it was a stomachache. I barely have energy to get up for 4-5 hours a day. I’m seeing a cardiologist this week…. there has to be a connection as my other injuries were cleared by MRI’s. Sometimes my heart flutters so hard it wakes me at night in terror. I feel like I’ve been losing my mind for the last year!!! Walking to the mailbox is exhausting. I was 49 when this started & my 97 year old Aunt has more energy thatn I do now.

  24. I am angry and outraged that the maker of darvon and darvocett knew that their product had the potiential to cause one to be addicted to be drugs. I have begun the withdrawal procces and it is HELL. This did not have to be had I known upfront that darvon had the potiential to be addicting and that it contained opiates.

  25. After reading all the comments above me I hate it when people assume that it was because people were abusing the drug! They havent take all of the other pain meds off of the market because they are being abused by soo many people and having overdoses and things of that matter! They are taking it off of the market because there is a reason for it! My mom passed away from taking it a very years ago from ” toxicity due to darvocet” and i can assure you all that she did not abuse the drug nor did she take more than she was prescribed! i am glad that they took it off of the market! Hopefully it will save a lot of lives from it no longer being on the market!

  26. i started taking darvocet after for years of taking ultracet and having regular blood pressure when i started darvocet now they say i have high blood pressure and high chloresterol never before have i had trouble and i always watch what i ate. makes me wonder, it only takes the edge off my back and neck pain. wish i could find a dr that would listen to me.

  27. EVERY medication has the potential to cause harm to some of the people who take it. Just read the adverse reactions and side effects on the printout you receive when you get your prescription filled. I have taken Darvocettes for over 25 years without any difficulty whatsoever. Also, almost all drugs have the potential for you to become addicted. If you take a medication and you notice any change in your physical conditions you should contact your doctor and stop taking it if it causes you problems.

    I have Stage 2 Hepatitis C. I have never been able to take any NSAIDs without significant physical distress.I have been taking darvocettes for a long time for the occasional bouts of severe joint pain I get from my liver disease. I have days when I can’t walk due to severe ankle, hip, or knee pain. After a couple of days of pain relief from the darvocettes my pain diminishes enough so I can put my crutches away. Now due to the short-sightedness of people like the so-called doctor in this video the federal government has recalled Darvon and Darvocette. I have no health insurance nor do I have the money to pay for the expensive drugs which will cause me a lot of physical problems if I could afford to take them. Thank you once again BIG PHARMA for eliminating another successful inexpensive generic pain medication and forcing us to purchase your totally over-priced and really dangerous new medications which by the way some insurance companies will not cover.

  28. So what am I to do???? I work a 40 hour a week job, (sometimes 80 during busy periods), I have 3 grandchildren, (2 of them I babysit on a regular basis), I grocery shop, go to church, and drive cross country at least once a year to visit my family and friends back home. Just the other night, I took my 8 yr old grandaughter out to the country to watch the meteor showers at 3 o’clock in the morning. We sat in lawn chairs and made memories she and I will never forget! I have been married for almost 25 years to a loving husband, and occaisionally we have fabulous lovemaking. ALL OF THESE THINGS ARE POSSIBLE BECAUSE OF DARVOCET!!! I have a torn disc, and a herniated disc and have been taking Darvocet for 8 years. I cannot take codeine, and cannot function on the other stronger pain killers out there. My heart is fine, and I’m not suicidal. So now what do I tell my boss? How will I push a grocery cart? How will I sit in church for 2 hours? When will I see my parents? What do I tell my husband? WHAT DO I TELL MY GRANDCHILDREN? Hey, If a women can “choose” whats right for her body and get an abortion, why can’t I choose whats right for me and have a life?

  29. One of the worse arguments I have heard for removing Darvon and Darvoncet is that they removed them in UK. They also banned owning guns. This is the US and we have the Constitutional right to decide what medications we put in our bodies. I think that Darvon and Darvoncet are two different medications and separate studies should have been made especially regarding liver problems.
    I just filled my prescription the day before the recall and told doctor if they discontinue making Darvon I don’t know what I’ll do. We’ve tried other medications with bad results. Alcohol is bad for the liver and how many deaths from drinking too much alcohol and how many accidental deaths from DUI drivers?
    What is left? Medical marijuana?
    Where are the divil rights lawyers?

  30. i have been takeing a large amount of darvon for condrloysis to the shoulder due to a defective shoulder pain pump. I wanted the least strongest medication I could take so I can function.I have had a quadruple by pass and I also have 14 stents in my by pass grafts and a heart attact on top of all of that and I have no fear of takeing darvon over any other drugs…I think it would be a set back in safe pain managment to permanently remove darvon and darvacett from the market/Gary

  31. everyone needs to use common sense and take responsibiltiy for their well being when it comes to how you care for your body. just because a “doctor”persribes a medication doesn’t mean it is the answer for your maladies. Did you read the labels when you got it at the pharmacy? it lists the side effects and benefits as well as the results of detailed double bllind clinical studies that last for years? i too suffer from “migranes” and take Topiramate which prevents “migranes” in the first place.

  32. All I have to say is that my grandmother didn’t have any heart problems until a few weeks ago her chest began to hurt. She was admitted to the Hospital. She has taken darvocet for a =while. She died Friday with a damaged heart……..

  33. I was on Darvocets for back pain,then i found out i have artherites. I was on them since i was 24 i am 40 now.I had perfect blood pressure and after i started the Darvocet my pressure was 150-90 and higher.

    I got off of them Oct 2008 and my blood pressure has been jacked up every since.I kept telling the Dr that it is because of the Darvocets. They wouldnt listen.Now they want to put me on blood pressure meds that i will have to take the rest of my life. And did i mention i still have irregular heartbeats and chest pain.

    Good luck to all of you experiencing withdrawls i have been there and done that it is very painful.

    Many Prayers,
    Lisa

  34. Jacqueline says:

    Now I know what caused my father to have a massive heart attack when I was only 12 years old at the so young age of 38 years old….. He was on this drug for years after having been shot and a 45 bullet lodged in his spine which they couldn’t remove as it would cause paralysis if they took it out, took this drug like it was candy and the docs at tripler would give him whole bottles of the stuff (not just a prescription amount the whole bottle of 500)… this really pisses me off as he was the best father in the world

  35. I have taken this drug for many years and have had no problems , I don’t believe that this was investigated enough. I know when and if this drug comes back it will look new and cost a whole lot more. Now I’ve been put on lorcets and they do little to nothing. Maybe those people were mixing other meds with them and already had some kind of heart problem.But now anybody who got good results from them is going to suffer too

  36. This drug is scary, my broth who was 45ys old had taken this drug for 10-15yrs due to several back surgerys, then BOOM!!!!he was dead they said it was from the toxin that this drug causes to bulid up in your liver and everything is fine then you take the next scheduled dose and WHAM!!!!it hits your liver causeing your liver to dump the toxin into your blood stream and you DEAD!!!!!!! He called and talked to my parents on Christmas morning and by 8pm Christmas night he was gone.

  37. Sydney Wolfe was at the heart of having propoxyphene removed. Here’s the story. Back 20 or so yrs ago, Mr. Wolfe brought suit against Eli Lilly to halt production of propoxyphene after it had been on the market since 1957. It had helped milliions upon millillions of patients through the years. Mr. Wolfe lost his bout with Lilly and was denied. Therefore. Darvon stayed on the market for many more years until Mr. Wolfe resurfaces again. I’ve often wondered if he saw a chance to get back at Lilly for his lost bid previously.Now just recently published is data showing deaths from oxycodone and hydrocodone having risen dramatically to a point never seen before. And get this, many of those deaths occurred in Florida! The same state that had the most propoxyphene deaths. Do you think INCREASED AGE might have played a part in deaths from both classes of drugs. Bottom line. Wolfe’s action took away a wonderful product as in Darvon that helped many, many patients. Yes, there were deaths from Darvon but smaller % than the stronger opioids. The FDA, by giving in to the threat of a lawsuit by Wolfe’s activist party removed a product that stood the test of time and served a very useful purpose by many. What an unfortunate and grave mistake. I say, put Darvon back on the market where it belongs despite the Sydney Wolfe’s of the world.

  38. Delores says:

    My daughter died from Darvocet on 12/15/2007. Her doctor kept her on it, even thouigh she complained of constant very intense headaches and her heart was bothering her. He told her the heart problem was because of damaged valves from being resusitated 3 times after being burned in a fire. He out ane out lied to her. Of course I found all this out after she died, and there was very little I could do about it, could not even sue because she would have had to have heart problems from it, which the doctor said she did not have, she supposedly had the valve problem.

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