Public Citizen Urges FDA to Issue Darvon and Darvocet Recall

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By: AboutLawsuits | Published: June 22nd, 2008

UPDATE 11/19/2010: The FDA announced that a Darvocet and Darvon recall in November 2010.

On Friday, the consumer interest group Public Citizen filed a federal lawsuit against the U.S. Food and Drug Administration (FDA) in Washington, D.C. The lawsuit alleges that the agency violated the law by failing to act on a petition filed in 2006, which urged the removal of Darvocet, Darvon and generic propoxyphene drugs from the market because they have been associated with over 2,000 accidental deaths, are physically addictive and are no more effective than other safer painkillers.

Darvon and Darvocet contain the narcotic propoxyphene, which is also available as a generic. It has been more than three years since British health authorities cited hundreds of Darvon and Darvocet deaths as the reason they ordered the drug to be phased off of the market, and it has been more than two years since Public Citizen filed their petition urging the FDA to phase the drug out. However, the U.S. drug regulators have not yet taken any actions to protect consumers from the dangerous side effects, and it remains one of the most widely prescribed generic drugs, with approximately 22 million prescriptions in 2007.

The narcotic drug is very addictive, yet it is a relatively weak painkiller. Public Citizen indicates that it is no more effective at treating most kinds of pain than other safer alternatives, such as ibuprofen (the active ingredient in Advil) and acetaminophen (the active ingredient in Tylenol).

“A large portion of the deaths from propoxyphene occurred because the drug is converted into a metabolite that is highly toxic to the heart and lasts longer in the body than the original compound, resulting in cardiac depression,” said Public Citizen in a statement released February 28, 2006 when they originally filed their petition. “Adverse cardiac events associated with propoxyphene include an interruption of heart transmission of electrical impulses, slowed heartbeats and a decreased ability of the heart to contract properly.”

According to data from the Federal Drug Abuse Warning Network, deaths related to Darvocet, Darvon and other generic propoxyphene drugs account for over 5% of all drug-related deaths between 1987 and 2006.

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There Are 52 Comments So Far • (Add Your Comments)

  1. [...] side effects, and has limited benefits when compared to other available drugs. In June 2008, a Darvocet lawsuit was filed against the FDA because they had not yet acted on the [...]

  2. i suffered cardiac deppression hallucinations and seizures, and lost my job…

  3. I am a true beleiver that this medication is dangerous.

  4. This medication causes major depression and I feel that it could cause a person to due serios harm to themselves.

  5. There are a lot of people addicted to this drug…docs writing the prescriptions are just dealers because it has no therapeutic value..they are just feeding the addiction. Patients get very upset when they are denied this prescription

  6. i have taken Daroxet for a tear now and have no side effects. it helps me greatly. i cannot tale tylonol it does not help me at sll. i cannot not take anything with aspirin in so this helps best for y pain

  7. I’ve noticed only negative comments have been posted here. I’m here to report that as a long-time user of Darvocet, I would be utterly dismayed to have this product removed from the market. I have received tremendous relief from my pains, mostly back, of arthritis. I do not see any signs of my being addicted to it nor have I had any adverse side effects. Nothing else gives me the relief that Darvocet does. If it’s removed, what would I use…a STRONGER NARCOTIC? I certainly hope not. The NSAIDs do not help at all. Tylenol alone does not help. Please don’t take this pain reliever off the market!!

    I’m voting to allow this medication to continue to be produced. I would be incapacitated with pain if it were not for this drug.


  9. I can’t take Ibuprophen or any of the NSAIDS & suffer pain…This was the best alternative. leave it alone.

  10. This is the BEST painkiller on the market when taken as prescribed. I have taken it after major surgery over Percocet or other stronger drugs and it has worked very well for me. I don’t like taking anything so milder is better for me. For more severe pain, I have taken 2 at once and it works as well or better than the stronger narcotics for me. I’ve used it over the years for different surgeries, toothaches, etc and have never had any ill effects. Like any drug, it has different affects on different people – we all have to learn what works best of us. It would be a shame to remove it from the market.

  11. [...] FDA advisory panel voted 14 t0 12 to recommend a recall of Darvocet and Darvon, as the benefits did not outweigh the [...]

  12. I have been on Darvocet for 26 years now. I am not addicted but then I don’t have addictive tenancies. I use it to take the edge off. I have RA. It is the best thing that I have found. I only take it when I can’t stand the pain. A bottle of 60 can last me up to 6 month. Not sure what I will go to next. FDA please reconsider and think of the people that REALLY need it.

  13. I took Darvon years ago. I had a bad reaction, with nausea and vomiting. The medication made me more ill than the pain. I had a ruptured disk at C5-6 and was given this for pain. I only took that one dose and then vomited in just a short period of time.

    My mother was given this drug in 2005. She suffered hallucinations, which were very severe and long lasting. She said there were men with knives that they were poking in her eyes. My mother was very ill at that time and in the hospital. She has since passed away secondary to complications from polycystic kidney disease.

  14. I have been on Darvocet 100 for at least 18 years and have never had any side effects that would ever cause me to discontinue the drug.. I have arthritis, fybromyalgia, bad back and knee and would be in terrible suffering without it. I am not addicted to it or never have been. Some days I take less than my prescription asks for and others the required dosage. I can’t take any other type of pain medication as it causes me nausea and I also have Gastro esophageal reflux – so other drugs I cannot take. Please don’t take it off the market!! Barb F

  15. I hope they don’t take darvocet off the market – it’s the only pain med that works for me. I’m allergic to almost everything else. I went to the FDA Website and posted a comment about it at
    by clicking on the little yellow dialogue balloon on the bottom right corner of the page.

  16. We – drs Ulf and Birgitta Jonasson from Sweden – have studied the painkilling substance Propoxyphene – Darvon, Darvocet – since 1994 and we think these drugs are the worst drugs ever.

    If you want information, please go to YouTube:

    Darvon, Distalgesic, Co-Proxamol – the worst drugs ever

  17. I recently used Darvocet to relieve the pain that I suffered from falling down my stairs and hurt my ribs. I do not feel like I want to become addicted to them nor am I experiencing any side affects. I tried to overcome the pain with ordinary Ibuprofen but it did not help what so ever. If you are becoming addicted to these pills then you need to seek other medical attention that deals with addiction not pain. I know people that are addicted to various pain killers and this one seems to be a common and easy one to obtain. Integrity has to play a part in your day to day decisions on whether or not you will CHOOSE to become an addict to this or anyother medication.

  18. I have used Darvocette for over 20 years, have never felt addicted to it and get violently ill from more potent pain meds like Vicodin, etc. Why take a pain med that is less addicting off the market so that I would need something more addicitng? Certainly people also get addicited to Vicodine, Oxycotin, ect. If a lesser does keeps people comfortable, why DC it? I suffer from a spinal stenosis, two herniated discs, chronic venous insufficiency and arithitis. Darvocette has always helped, and I have tired other drugs. I feel sick that It may be unavailable to me.

  19. My beautiful wife died May 20th 2008 due to an overdose of Darvon she was only 36 she left me and three children alone. Her pain management Dr. prescribed 120 to her a month it has taken me almost a year to get mad and let me tell you I am mad. She is missed by all and did not have to die this way.

  20. I became seriously ill 3 years ago – illness still undiagnosed, but Darvocet only thing that brings me relief. If it is taken off market it will seem as tho I have been given a death sentence. I will have to see what legal action I can take against those who have given me this death sentence.

  21. I have Rheumatoid Arthritis & have used Darvocet for many years–I only taken when needed –Many rheumatoid patients take this drug & Have The Medical NEED for it–How about the number of addicts on oxycotin & hydrocodene?? Why ban a less intrusive drug like darvocet, when you have so many others that are 2x as dangerous??

  22. I have been on Darvon and Darvocet for many years and find it to be a terrific muscle pain reliever. I just had a right sided hemi-colectomy and find that Darvocet relieves my post-op pain even better than the Percocet my surgeon prescribed for me, as it relieves the many muscle spasms I’m enduring post-op. I pray it will not be removed from the market as it’s all that’s between me and my pain!

  23. I suffer from severe headaches and have 3rd stage renal insufficiency. About 5 years ago, my nephrologist prescribed Lentogesic , a generic, for pain as he believed that it would be relatively harmless to the kidneys.
    About 5 months ago my pulse rate dropped to about 32 bpm during rest and I felt really sick with a “full feeling” in the chest. I also have a nasty cough. Visits to my my GP and cardiologist did not help as they were unaware of the side effects of the tablet, diagnosed my problem as sick sinus syndrome and suggested a pacemaker.
    I have just discovered the culprit and have discontinued the tablet. My pulse rate has increased but I do not know if there was any permanent damage done during the 5 months of very low pulse rate and blood pressure. The tablet was a terrific help while my body could tolerate it but the situation changed very suddenly.
    I guess the lesson is that patients and the medical fraternity should be educated as to the life threatening danger and react promptly else the tablet should be withdrawn.

  24. Please donot remove this pain medication I have OA neck back a
    leg pain from my back I have been taking this
    Darvocet for 20 Yrs This is the less narcotic that u can take to stronger narcotic I can get some pain relief from my chronic pain I will not be able to work if u take this drug off the market I have
    Never had irrg. Heart problems

  25. I have been taking this medication since I had shoulder replacement surgery more thahn 5 years ago. It has help with pain control for my shoulder as well as my hip replacement surgery.

    I use one or two tablets daily (weekly only) when I go to the health club
    to minimize the pain. It works very well for me and I don’t abuse it.

  26. I am DELIGHTED to hear it is going to be PULLED from the market. My mother (84 yrs old) has been taking it for three years. It is obvious to me that it doesn’t help at all. Her pain is off the scale. She takes liquid Morphine as well. Recently she went to her NEW phsycian at UCLA and he prescribed her Morphine 15 mg tabs and said that taking Darvon is like taking Tylenol. So, GOOD FOR THE FDA! It IS a pointless drug to take!

  27. I have been taking Darvocet for 14 yrs. NO problems. I am not addicted to them..only take for severe pain as nothing else works and Im not willing to take stronger meds. People need to limit the amount they take on any kind of meds.

  28. I am terribly upset they have removed Darvocet from the market. I have tried every pain medication out there, I am allergic to codeine based pain meds and I hate the way most others make me feel Darvocet and nothing works for me. Darvocet never took the pain completely away but it takes the edge off and makes life bearable. What do they propose all of us take other then methadone, oxy or some other extreme narcotic?

  29. I have been taking this drug for at least 6 years.I did not have a heart rate problem then, but I do now !!!!!!!!!! My heart rate is so unstable that I am on 2 heart meds to keep the rate low .NOW I know why,.It must be the Darvocet because I have had all kinds of tests and have never been DXed with heart disease, just the rate that is way too high.
    I will stop taking it today I can only pray that the heart rate returns to normal soon.Then maybe I can stop taking the heart meds too!!!!

    FDA you failed me SHAME on you for not listening sooner and doing studies sooner .
    I thought I could trust you.Ha boy was I a fool.I should have checked with the Brits then I would have known sooner maybe before I needed 2 heart meds!!!!!!!!!!!!!!!

  30. I have been on darvocet on and off for 6 years for hip, back and arthritic problems. I was diagnosed with depression 10 years ago and control it with anti depressants. I have never felt more depressed while on darvocet. if anything I feel happier because it takes the edge off the pain and I am able to function better. I am allergic to most of the other pain pills out there and the OTC meeds do not help at all. I hope there is something out there that will work for me or I’ll be back to laying around of the couch in pain and unable to participate in my childrens activities

  31. My husband has been taking darvocet 20 years. he has been prescribed as many as 4 a day of n-100′s. several years ago, he began to have an irregular heartbeat and atrial fib. He was hospitalized several times for this. He eventually had to have a pacemaker. He had always been active, playing golf and etc. He never had high blood pressure and had normal cholesterol and triglycerides, and was never overweight. He also became very winded. His mother and Father lived to old ages and never had a heart problem at all. It makes me wonder about the danger of darvocet.

  32. i have been taking darocets for about a year due to getting hit by a hummer,and ever since then my heart seems to feel weird ,and my arms and legs tingle….i had my heart checked they said i have a irregular heartbeat..that my valve doesnt shut all the way…hummm..thats so against pain pills..but i really needed them….and now all this praying things get better…:(…now what to take?

  33. My husband has been ill for many years. His diagnosis is uncertain for many years now. He has gastro troubles which were believed to be chrons for many years. It now may be spondy arthritis or lupus. He has been diagnosed with skin lupus.drs are reluctant to perscribe narcotics due to fed regulations, so they use anti-inflamatories or if not able to tolerate, darocet/ proproxy.My husband is unable to take anti-inflamatories by mouth(works well in injections).Darvocets are his only pain relief, although they don”t controll it well ,it is some help. without it what is the alternative? will he just have to suffer, which he already does. he has had high blood presure for a while the meds didnt work drs dont pay it much mind due to multiple other problems, the darvocets very well could be adding to this, but to take them may take the only meds he has been offered in 10 yrs

  34. This medicine has helped my pain. Why…b/c I don’t over take it and use it frugally. I didn’t want to get hooked on a stronger medicine and was the only one that didn’t make me nauseus or constipated. I don’t agree with it being addictive. The people who take it that “truly” need it understand it’s not a recreational medication. Go through a spinal fusion and feel real pain and a person will have much more respect for pain medications. Granted I’ve had problems with depression, etc. But, I have not linked the two together. Though, I will be seeing my heart doctor about this.

  35. This medication has been on the market since 1957 with a very low percentage of problems. It has been a wonderful pain medication with no side affects for most for several years. NSAIDS? Tylenol? seriously look at the stomach, digestive and liver damage they cause.
    Watch for the new medication that will still be under patent take it’s place at a cost most will not be able to pay.
    After all 22 million users equates to 22 trillion $$$ reasons to get that business.

  36. I have been taking this medication for over 3/4 years. About a year ago I started having issues with the rhythm of my heart, it would beat fast for no reason. I did not know what was happening, my medical doctor referred me to a heart specialist. I found out I have heart fibrillation and is now taking additional medication. Although the medicine did help my head ache, I do believe it could have cause the issues I am having with my heart.

  37. I wish that you self righteous do gooders would disappear. If you take a medicine and you have a reaction then just don’t take it again. Why do you feel compelled to take my medicine away from me because it didn’t work for you? It is the only thing I can take for severe Fibromyalgia and Arthritis. With this medicine I can exercise and function. Without it I will be bedridden and in terrible pain. I had to have a pyroplasty a long time ago and I cannot take anything Ibuprofen based or aspirin based, and this was the only medicine that took the pain away and had NO SIDE EFFECTS! Why couldn’t you just not take it if you don’t like it, why do you think you know what is best for everyone else? What is next for you Nazis? The Public Citizen organization is just a click away from getting rid of the books they deem “dangerous” and then the movies, and then the Internet! Where do they draw the line in “looking out for us” If you have a reaction to a medicine then JUST DON’T TAKE IT! But it might help someone else, tend to your own business and stay out of mine! This is just like the thought police, believe me, I have seen this happen before in Germany and we are skyrocketing in the same direction! Wake up people!

  38. I have been taking darvocet n/100 BID for 11 yrs. It work well for my pain. I am not faced with changing drugs, and i really don’t want to take another medicine that could be more addicting. I wish that they would have just left well enought alone. I do agree with Farnier, it is the money i am sure. I just wonder of they allready have another drug just waiting to be available. good luck to all of us and prayers

  39. I have been on darvocet for 30 yrs for nerve damage, neck and back pain due to scoliosis and collapsed vertebrae. Like many, I take it when needed, not recreationally. Pain is a very difficult thing to live with. If you haven’t had the issue, or walked in my shoes, how can you begin to know what works for me? I have been a health professional my entire adult life. I worked with pain, took care of the sick, and now in retirement, continue to suffer with the pain. I do understand the frustration and helplessness of people in pain. I pray that something will restore the hope and faith that people need to keep on in spite of relentless pain.

  40. These people are just plain STUPID!!!!!!!!!! I have been on Darvocet N/100 and Darvocet A/500 for 23 years. I have not had any of these side effects that these stupid people are talking about. I mean my GOD 5% over a 19 year span of drug related deaths. Do you reliaze that is less than 10,000 people!!!!!! And from what I am reading they are only talking about 2,000 people with heart problems or deaths combined!!!!!!! I agree with most of the complants WHAT ARE WE SUPPOSE TO DO NOW FOR ARE PAIN RELIEF??????? ARE THEY GOING TO COME UP WITH SOMETHING ELSE FOR US TO TAKE!!!!!!!! PUBLIC CITIZEN IS THE GROUP WE SHOULD SUE!!!! MAYBE IF WE TAKE ALL THEIR MONEY THEY WILL SHUT THE F****** UP AND STAY OUT OF OTHER PEOPLE’S LIVES.

  41. i have been taking Darvocet for a few years. i am so grateful my doctor believed my pain was real when other drs. just said take other the counter pain meds. they don’t work! i had suffered for yrs. in so much pain i was unable to do what i wanted. the other meds. made me feel sick. my dr. said i don’t want to see you in this pain and we are going to do what it takes to make you feel better. i am going to be 50 this month. i feel better now and can play with my grandchildren But trust me when i say it is only because i take Darvocet! i have to take 1 first thing when i get up with my coffee or i cannot move. i have tried believe me, who out there thinks we want to take pills everyday? i don’t want to be a pill popper or depend on anything pills. i try to take care of myself and be active. i love doing things and playing with my grandkids. if i didn’t have darvocet i would be sitting or laying down somewhere. i have tried other pain relievers and nothing helps like darvocet. the weaker will not work and the stronger ones are too strong. darvocet is prefect. i have been to bone specialist and chiropractors. my mother is 70 and does not take anything for anything. she took darvocet once because she fell and her leg. she agreed to a darvocet and said it was the best pain reliever she has ever taken. it didn’t make her woozie as others she had to take after surgeries. i think it should be case by case. our doctors should check us out and see if we are fine or not fine to take it. i love my dr. and i trust she would make the right decision for me and her other patients. i hope everything stays the same with this drug and they don’t raise the price because they know we need it. if it is unsafe and our drs. agree then of course i don’t want to take a drug i know will cause me to have a heart attack or something. i just ask that they make sure before pulling it. i just try to refill mine and they said they couldn’t. lucky i have some to last for a little while but not long. i don’t know what i will do if i can’t get anymore. i hope we are not forced to buy ours drugs on the internet?

  42. I’ve been taking Darvocet for little less than 20 years now. I have deteriorating discs in both upper and lower back. I work at a computer 8 hours per day and sitting for so long agrivates my condition to the point that I have to leave work sometimes. My doctor has put me on some of the other high-octaine drugs but I pleaded with him to put me back on my Darvocet due to the fact it was almost impossible to function and the pain didn’t go away. I take it as needed and I have done without it for varying periods of time without any ill-side affects. I’m like everyone else – what can it be replaced with. Motrin and like drugs have no impact on the pain for me. I this doesn’t put me back in the same painful situation I was in when I started taking the Darvocet. I think there are other drugs just as much if not more dangerous than this one. Why don’t these people go after them and leave us alone???!!!!!!!!!!!

  43. Darvocet has been my friend, or so I thought, for over 20 years. Off and on I have used it for back pain and RA. I take one at bed time to take the edge off of pain and calm my nerves. The result is a good night of rest. I have had heart arrythmia for several years now, had a heart specialist check me out on a regular basis and never once did anyone tell me to stop the Darvacet. No, I am not hooked on it but if it is addictive .I don’t know where the irregular heart beat came from………but I wonder. Money and greed? I guess we will see.

  44. This medication has NO stronger medicine in it the OTC tylenol! didnt anyone read the article though????? Ive known for years that this medication was completely pointless. its about time that the FDA did something about this worthless medication. i too have pain and i can not take certain painkillers due to allergies, gastro issues, etc but this medication was like taking a sugar pill. I only pray that it hasnt done any damage to my mother in law who is on massive quantities of this stuff!

  45. Ok so I have been given Darvocet for an old neck injury. I have gone through 2 scropts in the last 6mths and have had some funky heart palpatations going on. So much that Im going to a cardiologist next month. I wonder is that could be the cause of my heart problem. But then again I have had the flutters off and on for years. But over the last few months they have just gotten worse. Really scary now!!

  46. So Erica since you think that Darvocets are nothing more than a sugar pill then that means that you think that Tylenol with Codine in it is also nothing more that a sugar pill?????? Darvocets are more than a sugar pill and it works for my breakthrough pain. I am of the opinion that if the Darvocets are a problem for some people like Lesley who has by the way had heart flutters before she started taking Darvocets that they would just stop taking the drug and allow the people who need, take and do not get any of these heart palpatations to be able to contine you taking the drugs that they want and need to!!!!!!! For me to switch to OTC Tylenol I would have to take around 18 to 24 Tylenol PMs just to compensate the 7 Darvocets that I take a day. I would think that people like you would rather I take the 7 Darvocets a day and NOT destroy my liver by having to take 18 to 24 Tylenol PMs which would destroy my liver.

  47. No one mentioned how or why these people died. Overdose perhaps, if that’s even possible? I agree with several people here in that it is the only thing that I can take, as I have Fibromyalgia and current renal problems. It’s one of the only things I am able to take that truly won’t damage my kidneys further. Is this just another case of the few making decisions for the many? I’m disgusted with this behavior, such as now you can’t even pick up a cold medication without it being hidden behind the pharmacist counter & giving your life history to purchase it. Why? Because a few people used it to make what? Meth? Who knows? What happened to the people that died? I’ve taken this drug sporadically for years & never had a problem. Sure, if you use it incorrectly you will probably suffer from something. Duh! And if you think it’s addictive, it’s because the person had an addictive personality. I have never even felt the slightest NEED to have another pill. My mom used it for years when she was on dialysis, and never showed a sign of being addicted. Before that, she was in horrible pain.

  48. I have been takingh arvocet for at least 15 yrs prescribed by my cardiologist I can’t take anything with codeine so Darvocet was the best thing for me. Now in their infinite wisdom the governbment has taken away my pain medication & has not offered me anythhing in return. For all the people who have suffered reactions from taking this med, did you not read the warning label? it was very clear that the side effets can be heart rapid beating, etc. Have you looked at the warning label on the drugs that are left to take: Aleve, Advil, Motrin, kidney prioblems, etc. I don’t see how any anyone could file suit against the manufacturers iof Darvocet when they painley give the warnings. We are 21+ and can read & we choose to take this med we should be akllowed to do so. I’m very very sorry that people did die, but was it actually from Darvocet & nothing else?

  49. I have been taking darvon for about 45 years on and off. This drug has worked so well for my tension neck and back pain. Maybe some people took more than the directions stated. Have tried other drugs as, vicodin, tylenol/codeine and they do not relieve the pain. How does a medicine that has been on the market for over 50 years just now get discontinued? Please bring it back!

  50. i have taken this med for years for migraine headacks and it has worked very well,without any headacks and side effects,why take something off the markett that realy works for some of us,it should be our choice weather we want to take it or not..

  51. For god sales people I took the drug spairingly 1/2 tab for back injery for years when I finally took the whole pill for a few days it gave me a heart attack, at 40 , took again full 1 tab dosage as perscribed only once a day for back injury in 2003 within i week another heart attack, then took it in early 2005 for 3 days with another heart attack. Maybe it doesn’t hurt all people but who is to say my life is worth nothing it is just a statistic, I am an acceptable casualty for the drug manufactures.

  52. This is so interesting to me. When I was 17 I was in a bad car accident that left me pretty banged up. My doctors were content to keep me on percocet till kingdom come, until I requested a prescription for something less…intense. I was prescribed Darvocet. Well, after taking it my heart rate shot up. I went to the ER and everyone insisted I was experiencing an anxiety attack. Every time I suggested then, and since that there could’ve been a correlation between the Darvocet and my symptoms, I’ve been laughed off, brushed off and told that there is no possible connection between the two. I am glad that the FDA is doing something about this. Lord knows drug companies won’t, and Doctors won’t consider it. To pain sufferers here, ask your doctor to try you out on Ultracet. It is a non narcotic pain reliever that works.

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