Darvon, Darvocet Side Effects Needed Earlier Recall: Public Citizen

  • Written by: Staff Writers

The prominent consumer watchdog Public Citizen is blasting the FDA for waiting too long before issuing a Darvon and Darvocet recall late last week. 

In a statement issued on Friday, Public Citizen called for congressional hearings into FDA leadership, saying that negligence on behalf of the agency has resulted in between 1,000 and 2,000 additional Darvon and Darvocet deaths during the years after it should have recalled all propoxyphene drugs.

Darvon was first introduced in 1957, containing propoxyphene to relieve mild to moderate post-surgical pain. Today it is most commonly prescribed as Darvocet, which combines the active ingredient in Darvon with acetaminophen, the active ingredient in Tylenol. Darvocet has become one of the most 25 most commonly prescribed medications, which has been prescribed to more than 22 million people.

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

Public Citizen’s statement, issued by Dr. Sidney Wolfe, director of the organization’s health research wing, points out that Public Citizen first petitioned the FDA for a Darvocet and Darvon recall in 1978, when there was already evidence that propoxyphene-based drugs had limited effectiveness, were addictive, and could cause toxins to build up in the heart. However, according to the FDA recall announcement last week, the agency only recently received enough data to justify that the risks of Darvon and Darvocet side effects outweighed its health benefits.

The FDA’s decision came after the agency received new clinical data that propoxyphene-based drugs were linked to heart arrhythmia which could sometimes be fatal. The FDA indicated that that when the Darvon and Darvocet heart risks were combined with the risk of suicide, addiction and death, it was clear that the health risks overshadowed the benefits of the drug as a painkiller, which is not much more potent than most over-the-counter products.

Public Citizen said that the FDA’s claim “rings hollow” due to its own petition in 1978, as well as a decision by the U.K. to pull Darvocet and Darvon from that market in January 2005 after determining the drugs were too dangerous and had little benefit. Public Citizen again petitioned the FDA to recall the painkiller in 2006, and filed a lawsuit against the FDA in 2008 when the agency did not act on its petition.

Following the lawsuit, the FDA’s own advisory committee voted 14 to 12 to recommend a Darvon and Darvocet recall in January 2009 for the same reasons as the U.K.; that it was too dangerous and provided little health benefit. Less than two years ago, the entire European Union also announced a recall of the drugs.

“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.”

Wolfe announced that Public Citizen will push for a congressional investigation into the leadership of FDA’s Center for Drug Evaluation and Research (CDER), to determine who was responsible for the agency’s delay in taking action.

Following the recall, product liability lawyers are reviewing potential Darvon lawsuits and Darvocet lawsuits for individuals throughout the United States who have suffered serious or fatal injuries that may be related to their use of the pain medications.

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  1. Kurt Reply

    i have been on this for over two years. now i am taking it after my hip replacement. Can anything be trusted.

  2. Elizabeth Reply

    Well this is nice to know AFTER I’ve already taken it BUT discovered it was recalled when I went to get it refilled. If doctors know this why don’t they let you know this when you give you the RX? I had no idea this was going on and had I known I would not have taken it.

  3. Lacy Reply

    There are a lot of people that can only take darvocets to help with their pain. I myself take them for chronic migraines. According to my doctor there really isn’t anything else out there that compares to darvocet. What is going to happen when the people who are on this drug start going through withdraws and possible seizures or worse even death? Does the side effects outweigh the positive side for those who have chronic pain? Why not let the people who take the drug decide for themselves whether or not to take it.

  4. Carnell Reply

    Obviously the word has not gotten to some of the medical professionals. I just got a call from the military pharmacy that issued a prescription of Davocet to my wife telling me to tell her not to take the rest of her darvocet. Her plastic surgeon wrote the prescription last Monday!!!

  5. steve Reply

    I take Darvocet for pain, and I have noted that people would like to pull just about every pain med on the market. I have taken it for years with no ill effects. PERHAPS WE SHOULD JUST HAVE A STUPID PEOPLE RECALL! Recalling everything is not the answer poeple, perhaps people should be reponsible for their actions, and certain aspects of society should quit chasing ambulances.

  6. Sylvia Reply

    Almost every medication taken today has a side effect. It is ridiculous to remove Darvoset after 50 years.

  7. Kathy Reply

    I have been on propoxyph-acetaminophin 100-650 for the last 14 years. My health has declined rapidly during that time. I only weigh 85 lbs, have no appetite and cannot gain any weight. Also I have horrific headaches to the point that my head stays sore all the time. Some last up to 3-4 days in length.
    Why was this drug not recalled years ago if it is so powerfully dangerous???
    I am about to turn 60 and am afraid that I am damaged for life. Having 9 fractures in my spine is why I have been taking this drug since 1996.

  8. Joe Reply

    Darvocet is a good, cheap, reliable, non-addictive medicine. Someone wants to sell you something for just a few more DOLLARS, that’s all. All meds have side effects and abuse of anything will kill you. Look at their numbers, one thousand, two thousand, a guess? It is the drunk drivers that will kill you but more tax revenue comes from alcohol than Darvocet. Drive careful over the holidays for 5,000 healthy, pain free people will die on the highways.

  9. Mary Reply

    I have taken Darvocet N 100 for 20 years on and off. My doctor does not want me taking aspirin and without Darvocet the next step is and opiod or a narcotic. Darvocet N 100 has helped me with migraines, broken ankles, sprained feet and now at 60 a bad back. I have regular checkups with blood work and cardiograms and have had no problems. I have never abused Darvocet N 100. I have had more problems getting off Xanax. I think this is not as big a storm as the FDA is making it to be. Besides, the drug lobby has many new and more expensive drugs waiting for us.

  10. Marty from Modesto Reply

    I can’t believe that you are whinning about taking Darvon products out of circulation.

    I am a textbook victim of Darvacet. I receive massive amounts from Workers comp Doctors from 1992 to 2000. In March of 1999, I was diagnosed with Congestive Heart Failure cause by Arythmia. In 2000 I lost my job becasue the Darvocet cause damage to my heart and I couldn’t pass a D.O.T. physical. I now have valve problems.

    You guys that think this is fun or Davocet shouldn’t be taken off the market are just plain asking for trouble.

    This drug ruined my life!

  11. Carina Reply

    It’s a horrible idea to have people decide on their own what is best to take, obviously were not all doctors and only a doctor is able to give us real clinical advice and in depth look of what we all need individually…if people self medicated with all the addictions to pills how would that solve the problem? To me that would only mean even more deaths due to overdose. I think we should let the health professionals decide, true medical facilities can make mistakes but this is a medication that has been banned in other countries due to its potential risks, I say we go with the recall and stop complaining about it, there are alternatives!

  12. Marge Reply

    I was treated for atrill fibliration for several years. They even stopped and restarted my heart. But it did not work. I finally had a heart ablatioin. Then I had bi-lateral knee replaced (one year later the right knee had to be redone because the glue did not hold up. During this time I was on Darvon. I am concerned now what damage was done to my heart.

  13. Johanna Reply

    I have taken Darvocet-N 100 tablet for over 5 years. It helped me tremendously while going through knee pain for years. After knee replacement surgery I continued to take a pill here and there when I overused my knees. I have had no known problems with Darvocet and hope there is a good replacement for it when I run out of them.

  14. Carole Reply

    What can be done to refund those of us that have purchased this medication recently in a large supply, I think a form of fiscal restitution should be established.

  15. Jnut Reply

    My doctor gave me these Friday as I was leaving the hospital after a c-section then personally called me on Monday to tell me to stop taking them. He told me to take them back to the pharmacy for a refund (I paid cash, insurance would not cover). Walmart said they could not refund my money. So why if peanut butter or cookies get recalled do we get to return it and get our money back but not medication? $25 is not a lot but this day and time I could sure use it towards diapers or baby milk. Just sayin’ 🙂

  16. Betty Reply

    I wish I was aware of the heart arrhythmia connection sooner. I have been on up to (4) 600mg tablets for a few years now with fluttering sensations of my heart for at least 2years now. The doctor insisted there was nothing to worry about. Since stopping the generic of darvon I no longer am feeling the misfirings of my heart which I was told was related to back flushes of the heart and nothing to worry about. Consider this when continuing to take what you have left. I am getting rid of what I have left of the medication. Dr prescribed hydrcodone in lieu of darvon for me.

  17. Audrey Reply

    I have been taking the generic Davocet for 2 yrs pre-knee replacement and post knee surgery….after my surgery in April I had a slight heart attack from episodes of my heart beating 180 beats per minute..
    The heart doctor did not tell me to stop Davocet and so I am still taking it for my other arthritic pains, and nobody has told me to stop. If I am causing my self harm…I want to know it.

  18. Brandie Reply

    My doctor’s office was informed of the recall by a pharmacist after another patient tried to refill a scrip. The nurse who informed me of this said they still had no idea why it had been recalled. Now I have to worry about the alternative drug the doctor prescribed for me!

  19. Stephen Reply

    I Watched my mother take this since I was a small child until my mother passed away two years ago. I just turned 33,if that gives you referance on the lenght of time she took it. When my mother passed it was her heart, I have to wonder now if she might still be here if not for this drug. For thoes that remarked that they have to go on opiates, I got news for you, darvocet is a opiate and very addictive and the real kicker is it does not even work well. In most cases 800 mg of motroin will be a better pain reliver. If that wont work try tramadol its much stronger and much better for you.

  20. jennifer Reply

    I tried to get my script refiiled on the 29th the dr approved it, the pharmacy wouldn’t. I’ve personally not had any prob. that i know of from the drug, but i’m allergic to tramadol. So….now i’m gonna have to find something else that’s safe to take and not to mention get used to it ALL over again for them to recall that too……

  21. Jeanne Reply

    I can only take Darvocet for bone pain due to my cartlige being worn out or gone all together. I have taken this drug for years with no side effects. Maybe the FDA should look into the other meds the people with problems taking this med were taking as well and not allow those to be prescribed together. This is really unfair ti people like me who are just left out in the cld without anything to take.

  22. Patricia Reply

    I have been on Darvocet for more than 20 years. I do have have heart arrhythmia and chest pain, but I also have Sarcoidosis. I’ve been dealing with daily pain for more years than I can count. Not sure what to do next, especially since all medications have potential severe side effects.

  23. Kristie Reply

    My husband’s death certificate says “acute darvon toxicity” — he died from it… I found him in bed one night and he was VERY careful with his medication. He took darvon because he did NOT want to take things like oxycodone and other dangerous/addictive painkillers. Little did we know. 🙁 Docs said it accumulated in his blood over time. That was three years ago. I had an overwhelming emotional response when I was suprised with the news they finally recalled this stuff. A little too late for my husband… So sad. And he was only 34. He was a bilateral amputee that worked long days on prosthetics as a verterinarian… What a shame.

  24. James Reply

    I have been taking 5 Darvocet tablets for the last 2 1/2 years along with 9 years of 1mg. of Klonapen 2 times daily, 2 20mg of Prozac daily because of severe back pain and anxiety and sleep problems.Recenty my Doctor added .5 mg of xanax nightly to help me sleep.I found that I was beginning to consume more alchohol on a regular basis. I began to realize my personality was changing. I started researching the side effects of all these things and went cold turkey for 2 days and felt I was goin to die.My Doctor advised me to cut my medications in half for 2 weeks and another 2 weeks of 1/2 of that. It has been 8 days since I tried cold turkey. I am improving daily,but it still is a battle where the withdrawal sytems come and go in waves.I will never again take a controlled substance.
    As for the darvocet,there are severe side effects upon quiting.I do not think most Doctors are aware of this.Please check with them before quiting and going to non opiate based replacement. I have talked to many people whose Doctors are unaware of the withdrawal problems.I think Darvocet should have been given a 30 period before pulling it. It would have allowed people to wein off of it.
    “Coming out of the Dark”

  25. Bobbie Reply

    I too only found out about the recall when I called in for a refill .I too had
    fluttering sensations as well as fullness in my heart but never associated it to the Darvocet because I had taken it before without any problems .When I asked the pharmacist why it was recalled he stated some people had heart problems,but it may have been a pre-exisiting condition.

  26. melissa Reply

    I have take this medicine for 3 yrs for back pain problem and I have no problem taking it. Its really help the pain and sleep better. I just found out this am from nurse that its was recall after doctor put me on tramodal and i had a bad nite with my heart beating too fast So I cant take that. I was hoping it’s come back on market soon.

  27. Barb Reply


  28. Barb Reply

    I have been taking Darvocet for 12 years. Last year during foot surgery, I went into Atrial Fibrillation. I had a stress test and a monitor that neither showed this. We do not have this heart problem in the family so I am thinking it is related to taking Darvocet. I cannot take a lot of other pain meds like those with codeine, or Demerol, or Vicodan. I do not know what to take now!

  29. JohnC Reply

    I was in the Air Force from 1956 until 1976, During that time, Darvon was the pain-killer of choice in many (most?) circumstances. In 1985 I had my first Atrial Fibrillation attack while I was driving my children to school – not a nice occurrence. Over the years the attacks became so common I might have as many as three in a day. I am taking medication to control it, but it’s a type of medication that has its own restrictions what ever happened to all those herbal medicines?.

  30. Rick S Reply

    Been using for 25 years ….now using Oxycodone and hate the stuff. Class two regs are hard to deal with, cost is high, stigma is ridiculous. Put a black box around it and allow those that want it to have it!!!! I feel like we are living in a communist country! FDA …..wake up!!!!

  31. jb Reply

    I have taken darvocet for over 15 years with no side effects, it works better than anything I have tried. It doesnt affect my ability to drive or work. Additionally, I have a relative who has taken darvocet for over 30 years and is in her 90’s !! hmmm? How about looking at the new “exotic” drugs like Celebrex, that have a litney of precautions, like internal bleeding, heart attack! and “may cause intestinal Cancer!!”, Darvocet was pulled because the drug companies cannot make a major profit from it, now they can put the new “exotic” painkillers on the market at 10 times the cost and make millions!!!!,, I agree, lets have a stupid people recall, If they can put meds on the market like Celebrex and the new Statin drugs, that cause more harm than good, then Darvocet should be ont he market as well.

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