Darvon and Darvocet Recall Issued Due to Risk of Heart Problems
The popular painkillers Darvocet and Darvon have been recalled by the FDA after it was determined that all medications containing the painkiller propxyphene pose an unreasonable risk of heart problems.
The Darvocet and Darvon recall was announced Friday afternoon by the FDA and Xanodyne Pharmaceuticals, Inc., which manufactures the popular pain medications. All generic Darvocet and generic Darvon versions of the medication have also been recalled.
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 25 most commonly prescribed medications, which has been prescribed to more than 22 million people.
An FDA advisory panel first recommended that the agency recall Darvocet and Darvon in February 2009, after determining that the minimal pain relief benefits provided by the drugs do not outweigh the substantial risk of overdose and suicide. However, the FDA decided in July 2009 to allow the medications to remain on the market with a new “black box” warning about Darvon and Darvocet side effects, which is the most stringent warning label possible under federal regulations.
On Friday, the FDA determined that new clinical data, which show that side effects of Darvocet include an increased risk of serious and sometimes fatal heart rhythm abnormalities, tipped the scales in favor of a recall, after determining that the risks associated with Darvocet and Darvon outweigh the benefits provided by the treatment.
The FDA indicates that it has been petitioned to recall Darvocet and Darvon from the market twice since 1978, but only now determined that the risks outweighed the benefits. One of those petitions came from Public Citizen, a consumer advocacy group, which called for a Darvocet and Darvon recall in 2006.
A phased Darvon and Darvocet recall is already underway in the European Union.
“With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” said Dr. Gerald Dal Pan, director of the FDA’s Office of Surveillance and Epidemiology. “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once the patient stops taking propoxyphene, the risk will go away.”
The FDA said in its announcement that it will advise health care professionals to stop prescribing Darvon and Darvocet to patients and said patients currently taking the drugs should contact their health care professional as soon as possible to discuss switching to another pain medication.
90 comments
When Darvon first came out, I was 12 and had just started my period, and the pain was well beyond OTC help. My doctor prescribed what was then called Darvon Compound. It contained 65mg of propoxyphene and ACP, “aspirin, caffeine, phenacetin.” It got me through high school, college and grad school before my cycle changed. In the meantime phenacetin was withdrawn from the market, the caffeine was taken out, and aspirin changed to acetominophen. I began taking it again several years ago, minus the acetominophen, for breakthrough pain following a severe injury. It has never caused me any problems at all over 50 years of intermittent use.
I have used darvacet for 15 years for lower back pain. I’ve never had any heart problem or any adverse side affects whatsoever. It works and allows me to function without drowsiness. I’m sorry for those people who have had heart problems due to the use of darvacet, but I will miss them and want to continue taking them. My primary care physician is a cardiologist and he has never known them to be a problem in his 40 years of practce. Please put them back on the shelf for those of us who have no adverse reaction to the dru
I am 22 years old and had heart failure after I had my baby. Here is my story: On 9/15/10 I gave birth to a precious baby girl. On 9/17/10 I was released from the hospital everything was fine blood pressure normal. I was given a prescription of darvacte for the pain. I filled my meds on the way home from the hospital and started taking them that day. On 9/19/10 @ 3:30 a.m. i woke up from my sleep and was coughing and having trouble breathing it sounded like I was drowning when I took a breath, I knew something was wrong so I rushed to the er and was told there was something wrong with my heart, and the fluid was going back into my lungs. I was admited to the hospital and was told I was very lucky I didnt just lay back down and go to sleep. (Keep in mind that I just had a baby 4 days before.) They ran test after test and couldnt find a reason for my to have heart failure. I stayed in the hospital for 4 days on oxygen receving water pills to get the fluid out of my lungs from my heart. I still have a leaking valve due to the heart failure. My pregnancy was normal no high blood pressure no problems at all. I know that Darvace caused my heart failure and almost took my life. So for all of you people who wish to keep taking this medicine I hope you never have to go through what I went through it is very scary when your heart stops working. And the feeling of thinking you are going to die right after you had your baby is something that I will remember for the rest of my life.
I have taken Darvon 65 mg off &on for over 20 years. I have never had a side effect due to this medication that allows a person to FUNCTION with CHRONIC PN. I have herniated discs , Fibromyalgia , connective tissue disease RA and also Osteo- arthritis. My husband is a Pharmacist & agrees that is a sad day for all of us who want to stay AWAY from the HEAVY- SCHEDULED NARCOTICS. I am 61 yrs old & have about 15 pills left and I suffer To RATION the last of my prescriptions. This should be the PATIENTS CHOICE. READ the warning LABELS on other meds_________________.
It’s too late for my son, he died in October 2009 after taking the drug Darvon. While it may relieve your pain temporarily, the pain of loosing my son to this drug will never be relieved. One accidental death is too many, this drug is harmful and should be taken off the market. Imagine your child dying because of the harmful effect this drug. Kayla if you are reading this comment, I just want to let you know how thankful I am that you were able to get treatment. I don’t know you, but knowing that you survived and are able to be there for your daughter is probably a miracle…
I have taken generic Darvacet for twenty yrs for arthritis with no problems. They need to investigate Lortab, which is very addicting and does not help pain as well.
My brother recently died after taking the generic for Darvon, propxyphene, for several years. He had a sudden heart attack (actually 5-6 heart attacks). For those who want to continue using this drug, please know that its like playing russian roulette.
@Kayla…I had a very similar situation happen to me with the heart failure after delivery…
Well I am just finding out about the recall. I was prescribed Darvocat during my entire pregnancy for severe headaches, being told it was perfectly safe for the baby as well as myself. This is nice to know now. I am not having any issues but m concern is my child. I hope none of this effects him in the long run. He seems to be a happy healthy 4 month old!
I would like to take great exception with all of the comments from people who believe that the acetaminophen component of Darvocet is the only aspect of the drug that provides pain relief. I have had Fibromayalgia and Multiple Sclerosis for 20 years, and I am very, very sensitive to all medications. I can tell you that even Extra-Strength Tylenol does not begin to touch my pain when I have a serious flare of FMS, or a really bad bout of spascticity from MS.
Darvocet has been a life-saver for me for all of these past 20 years. I do not take it regularly. I only take it for break-through pain, it works great, and the only side effect it has for me is that it can cause some nausea if I take it on an empty stomach (which is true for all narcotics. I recently had a complete cardiac workup at the Mayo Clinic, and my heart is in great shape. It has given me relief from excruciating pain when my regular meds of Tylenol, NSAIDS, or Tramadol is not enough.
I would like for everyone to remember that there are patients with CHRONIC pain, and for us it is a daily balancing act to just get through the day. For those of us who cannot take codeine, we do NOT have an alternative drug that is “just as good.” If they are worried about overdosing, addiction, and suicide with Darvocet, why are the same concerns not just as valid for oxycodone (Vicodin) or Percocet, the next options after Darvocet if OTC pain killers or Tramadol is not strong enough? Do the powers that be actually believe that we will all be better off using Fentanyl or morphine! (Look up their side effects if you are not familiar with them.) Without Darvocet, these drugs are the next step up for severe chronic pain if a patient cannot take codeine.
There are so many drugs that are prescribed daily for other medical conditions that have an even higher risk for heart conditions than Darvocet. I believe that a decision to take a drug such as this and to weigh the risk/benefit options should remain between a physician and his/her patient.
How would all of the healthy, pain-free people, who came up with this idiotic idea, like to live with the side effects of the stronger, alternative drugs that will now be our only option, every day of their life? I would like to remind the Public Citizen group that for the niche of chronic-pain patients in this country who cannot tolerate codeine, they have just handed down a crushing blow to possibly millions of peoples’ quality of life. Thank you very much, and also thank you FDA.
So, the almighty FDA has withdrawn another useful and effective painkiller off the market.
It’s great news for hypochondriacs and lawsuit-happy people who want to blame all of their health problems on a drug, and not on the fact that they weigh 300 pounds and eat McDonalds while they sit on the couch every night, but what about people like me who are allergic to aspirin (which knocks out a WHOLE class of prescription pain killers) and can’t take Percoset?
Darvocet has been the only pain reliever I could have after surgeries, and now that option has been taken from me. Darvocet is quite literally the only thing hospitals can give me; Percoset makes me hallucinate — I say take THAT off the market!
My only pain reliever option has been taken from me by the nanny state. I am allergic to so many things … what am I supposed to do next time I have surgery? Chant and light a scented candle?
And where do they get the idea Darvocet does not relieve pain? Have any of these government bureaucrats ever had a C-section? Darvocer got me through the aftermath of a C-section and gallbladder removal and worked just fine.
I would be happy to sign a waiver and be allowed to take Darvocet, but nooooooooo, the government says I can’t make my own decisions.
And also, those of you who are posting about losing loved ones who took the drug for years, maybe that was the problem — it was taken for years. Why should a drug that is the only one that works for people who are allergic to other painkillers be taken off the market? WE only want to use it after surgeries. ANY painkiller is dangerous if you take it for YEARS. I only want to be able to take it for 2-3 DAYS.
I had been on Darvocet for over 12 years. It was prescribed for my nerve pain I suffered in my back and down my leg. It worked for me. I took 3 pills sometimes a day..or just 2. My prescription said….one pill 3 times a day as needed for pain, every 4-6 hours.
I have been suffering from irregular heartbeats, to atrial fib at times, where my heart rate was so erratic, my husband could not take my pulse. I of course stopped taking it when it was pulled from the shelf. I still occassionaly have the irregularity in beats. Am I to suffer with this the rest of my life. I am 73 years old.
My twin brother Keith died of “acute propoxyphene intoxication” in November 2001, aged 20. It was an accidental Darvocet overdose. This recall is too little too late, but I am still glad they finally took this dangerous drug off the market.
I recently published my first novel based on Keith’s death, and was mentioned in the January 9, 2011 Sunday St. Louis Post-Dispatch. Anybody interested in a story about brotherly love, addiction, tragedy, and perseverance, please check out the story, and my novel:
Post-Dispatch story:
http://www.stltoday.com/entertainment/books-and-literature/article_0bb86a3d-ac4f-5601-83a7-09632e7385e9.html
Book Link:
http://amzn.com/1452826544
I just found out about this when I went to the pharmacy to get my prescription refilled…and I am pretty upset with it. I don’t take Darvocet that often, it’s prescribed for my arthritis (both knees) and back pain (i have a straight cervical spine instead of curved which causes extreme migraines), but Ive never had a problem with it. I was on hydrocodone 10mg, but I couldn’t move around or be normal on it because I was completely numb. I am 26yrs old and a single parent to a 4yr old, I have to be able to function without being “doped up”…so now I don’t know what I can take for the pain. I was getting steroid shots in the knees every 6wks but my ins isnt paying for those anymore…so this news with Darvocet is frankly upsetting!!!
and omg i just found out when i went to get my presciption filled today 1/20/2011.why no one told me or my doctor didnt call me why?wondering if thats why all the anxiety?i have been on this med for about 2 yrs if not longer.
Hi Karla, we both seems to encounter the same problems. I am 33 years old I gave birth on 10/22/2010 this is not my first child. I was in the hospital for 3 days after my C-section. On 10/25/2010 I was released, I was fine with no complications. On 10/26/2010 I went to walmart feel out my prescription (Darvocet N-100 its generic version. A few days after taking it, I started having unbearable pain thru my arms, and shoulders. I was nauseous, and felt dizzy. I would go to my shower every time I felt pain. I used warmed water to help ease it. Everyday I continued taking the pills. After eight days, of misery I had a terrible heart burn went to Walgreens, bought prolosec OTC it even made me feel worst. I taught I was going to die. It was that bad. Finally, the next day; I couldn’t take it anymore. SO I went to the ER, I found out it was a heart attack, blood pressure rise up to 164/100 I nearly died that day. The cardiac surgeon thought that I had a blockage to my arteries. He inserts a stent thru my arms to my heart. He had lots of questions. He himself did not know the reasons why I end up with a heart attack. He was in shock because” he concluded that he only seen my case once in 10 years of med school”. I was watching TV. I heard there was a recall on Darvocet. Right away I knew this pain killer almost killed me. I know the heart surgeon will never admits that it was do to taking Darvocet that did this to me. Because I could not remember the name of the medication I was taking at the time of the incident. I was very confused that day. Of course these Doctors get big “gifts” from the drugs companies. They would do anything to keep you from the truth. But, I know the grace of God has keeping me alive; otherwise I probably would be buried somewhere right now. No one can tell me anything different.
I have been, had been taking darvocet since 1990 when i had a ruptured disc and degenerative disc disease. i had a spinal fusion and was sent home with this med. i have been prescribed this medication for the last 21 years over and over again. in the last few years, i have begun having rapid heartbeats, i wake up in the middle of the night, and my heart is just racing away, i feel like it is going to explode at times, these “spells” occur all the time. i have discussed with my dr. but he never seems to have any worries about it and never was i told that this drug was a danger to my heart. he just recently stopped prescribing, once the ban was issued, but had no suggestions for anything else and did not want to discuss the effects of the drug or if my heart racing episodes were connected. he just kind of blew me off about it. how can i find out the info i need, do i need to speak with an attorney, what do i need to do?
I have MVP (Mitral Valve Prolaspe) and have had continuing problems with my heart every since. Needless to say I have been taking Darvocet/Darvon for over twenty years, for one ailment or another. Many times the Docs tried to turn my pain to that of being im my head, wonder how many times ‘Darvocet/Darvon’ played a part in all the msery and pain I still have until this day.
And wonder why the FDA played around with this drug for so long before a recall, 2006 up until now is a travesty!
I have taken Darvocet for years due to spinal stenosis pain. I have tried surgeries, shots, implants, but nothing worked until the Darvocet. Then they took it off the market and have put me on Percoset which makes it where I am either half stoned all day or completely stoned. Yeah it takes away the pain but I can not function. I am disabled enough because of my back, taking a medication off the market that worked without all the side effects of nausea, numbness, dizzyness etc. has just been more of a hinderance to those of us that have chronic health and pain problems.
I have taken Darvocet for 10 years and never had a problem. It helped my pain ..Getting on a class action law suit is not as easy as you think..I had some medical problems before I took Darvocet so I know it was not the darvocet that caused it..Remember you get something for nothing..If it was truly darvocet that caused problems then get on the class action but dont try to fool anyone..
Been taking Darvocet over 20 years, no problem. The REAL story is, the patent expired and Darvocet is no longer worth MONEY to the drug companies. So they want us to take the more expensive and dangerous hydromorphone or Oxycontin. Drug companies now own the FDA. End of story.
I am a healthy 38 year old male who took Darvocet post op around 5 years ago. While taking the medication my heart would skip beats and speed up. This was very scary. I felt like I was having a heart attack. I have heard that the effects of the medication were not cumulative nut it is still doing it today and seems to be getting worse. I have went to the emergency room twice because I thought I was having a heart attack.
I took darvocet for about five months and I have been having a lot of irregular heart beats and not feeling well. I’m very afraid that i have some damage due to taking darvocet. What do I do or who do I consult with?
I have taken Darvecot a good while ago. then I was put on Percert instead. I use it when I have a MRI image done or any test done that I am in an inclosed machine. I am clostaphic . I am a diabetic for about a year.In july 2010 I begin having some pain and pressure in the middle of my chest. After seeing my medical dr. then Cardologyist, then Surgeon I had to have Open- Heart surgery and triple bi -pass on Sept.9th.2010 . I anm not taking either of them now. Thank You, Janet
I’ve taken Darvon 65 mg. for menstrual cramps as a teen-ager, for Peripheral Neuropathy, and IBS, as an adult, for many years now, with no ill effects at all, only relief from pain and spasm. It is the only pain relief drug that has no side effects, and really works for muscle spasm related pain. It’s a great muscle relaxant, and I was appalled when it was finally removed from the market by FDA after years of relentless campaigning to have it removed, by Dr. Sidney Wolfe of Public Citizen. Neesless to say, I don’t contribute to Public Citizen any more! Many people are being affected negatively by its removal, and in all the years I’ve taken it, I’ve never heard of any heart abnormalties or arrhythmias caused by this drug. I’d like to see these “statistics” its removal was based upon, which have not, to the best of my knowledge, been published anywhere! The real reason this drug was removed from the market was that many people were using it for “self-deliverance” and the Government and hospital system, doctors, etc. don’t like people with Cancer and other terminal diseases “offing themselves” (for which this drug is very effective), because they lose billions of dollars for extended end-of-life care! Wake up America!!! What a travesty this is, and how many people will suffer in pain without this fine drug.
There are side effects to every drug out there. There always have been. Unfortunately, many people are informed of risks – from addiction to death – take the medications anyway, then are shocked when they are negatively affected by side effects. Then they sue. And sue. And sue. The information on medications is out there…it’s up to the consumer to take responsibility for what he or she puts into his or her own body. Yes, there are cses where negative effects are masked or hidden or denied by drug companies in order to avoid lawsuits. But there are way too many people who willingly ignore warnings and cautions, or just don’t even bother to check out what they’ve been prescribed before they start taking it. Some will take or do anything their doctor tells them to – without asking what it is or why they’re doing it. I used to schedule radiological tests for patients. I’d have to ask why they’re having a particular test, so that the radiologist knew what he or she was looking for, and every day at least 3 or 4 would say “because my doctor told me”. I’d try to get more information but they would have no idea why a doctor ordered a CT, or an MRI, or any number of other exams. The doctors aren’t much better – a drug rep says “prescribe this” and they do.
Every patient needs to take responsibility for their own health – if your doctor says “take this”, ask what it’s for, what the side effects are, why a test is being done, what it involves. If you’re on this website, you have access to the internet – use it!!!! Don’t stick your head in the sand and then cry “victim”. If every drug with negative side effects was pulled from the market tomorrow, there would be nothing on the market at all.
My mother passed away July 26th 2006 due to cardiac arithmia wich was caused by taking Darvocet. She was only 43 years old and a very active healthy woman. She was only taking the meds for a short time as she had just injured her back. If she would of never taken Darvocet she would still be here.
Does anyone think Sidney Wolfe and Public Citizen are going to stop with removing Darvocet from the market? No way–Their game is to get rid of all Opiates and all Opioids, and pain suffers be damned.
I have not taken Darvocet in about six or seven years but, at the time I was taking Darvocet, i was taking it very regularly. When I think of it now, i probably took too much, but it really was the only thing that worked. Las week I had an unexpected catherization. I had a 98% block in my heart and a 50% block in my heart. The doctors inserted a stent. So, now, for the rest of my life, I am taking plavix and a asprin a day. Can my heart problem be directly related to my use of Darvocet? I wonder?
My Mother died suddenly years back. Sudden death syndrom. She took Darvocet for perhaps a year or more. Went from a healthy woman to a drug addict. Even gave up smoking. Which would have been strange. ANyway, I called her everyday. She spoke of vomiting, hard to swallow, did not walk two blocks to town anymore, dizzy, lightheaded, bloated up or overweight though same diet, hair loss, trying to remember everything, started wearing pee pads, fell and afraid of falling. She did not tell me she was using darvocet, but I guess it did effect the quality of her life. Even though she was a young 76 and always thin and active, she became a drug addict. 3 times a day. She overdosed. One pill was left in her bottle when I went back to bury her. She had 7 days to go before prescription time. Yes, it does ruin peoples lives and kills them. And she was always telling me how tired she was. Nice, huh?
I spoke with the FDA. Was told THOUSANDS of patients have called them protesting ban on Darvocet. I was advised to ask my reps. in Congress to push for a reversal of the ban. I am in acute, chronic pain 24 hrs/daily. Darvocet only drug that gave me back some quality of life and a few hrs. of relief. No side effects whatsoever. After years of relying on it I am now “swinging in the wind” because any substitute prescription from my doctor has proved useless. I’m trying to find the consumer group in Washington, D.C. that the FDA told me to support to have the ban lifted. So far, I cannot find them. Anyone know and can share info with me? Time is of the essence.
Ok, well I have been reading the posts about the small handful that have no negative effect from this drug. I want to say you FEW are lucky, and it is a seriously dangerous drug if it is causing more problems then healing. For a drug to be safe, it has to have over 50% beneficial properties. However, this drug was released long before strict FDA rules were in place. Now, the FDA has realized exactly how deadly this drug is, and did the smartest thing they could. Stop blaming the FDA for being power mad, when they are actually responsable for hundreds of deaths.
Josephine, the reason you are “swinging in the wind” is because you are addicted to it. The addiction to any medication, especially pain meds, causes any others to be useless. So a couple thousand that the drug works for is worth the THOUSANDS that have DIED because of it? How selfish can you people be? I would rather be in serious pain, which I am, then see people dieing from a drug that was killing people everyday, that were using it correctly. I guess I am being biased for thinking of the people that are dead now, that took the medication the way their doctor prescribed due to something they had no control over. Time is no longer of the essence for the people that lost loved ones, but I say we bring it back for the selfish few that refuse to live without a dangerous drug on the market.
Here it is good people! I’m truly sorry for anyone who has lost a loved one, but the bottom line is this – we’re all gonna die sometime from something. There is no drug (i repeat no drug) that isn’t a problem for someone eventually. Everybody expects a guarantee that if they see a doctor or take a medicine or go to the hospital they won’t die. Guess what? We’re all gonna die eventually! If you are going to take medications you have to accept that a risk exists. You accept risk when you drive a car, eat, or sit in Church. Darvocet is not a bad drug for the majority of people who used it – in fact it is the only medicine that helps for many. Your remedy for a drug that is misused or fatal is to file a lawsuit – why, cause you ain’t bringin that person back…period. You roll the dice you take your chances.
Me? I’d like a class action suit to bring darvocet back to all those folks who need it.
I was prescribed Darvocet and Celebrex (pre-recall) at the same time. I had the side effects. I felt like I was having a heart attack. Once it felt like death was in the room. Freaky stuff. I was just looking for relief from SLE, fibromyalgia, stage III endometriosis, & the beginning of MS (diagnosed 18 months later)…and taking care of our 3 young children.
Personally, I’m GLAD the drug was banned. And honestly, some of the comments I’ve just read…Tsk Tsk…just show people don’t do ANY research on their medical care or prescriptions (judging by the inability of being able to spell a medicine’s NAME, it leads me to wonder about their entire comment).
Oh and I have to say two other things. #1: the group at the forefront were actual victims of Darvocet & not out to ban ALL opiates or other pain medications. That comment sounds like an email hoax.
#2: The FDA didn’t ban this drug because the patent was up. That happens all the time, and hence…we get generics. The DRUG has been around since the 1950’s and the manufacturer DID NOT CARE about people dying. You only know the tip of the iceberg.
Do your research. Learn the facts about your health and learn about the medications you’re prescribed (#1: the name). Be proactive! Eat healthy. Exercise (I do and I can’t walk & it hurts…but it’s IMPORTANT).
And remember, each time a drug is removed from the market, 3 more pop up to take over that niche. I’m sure you’ve found relief like I have.
I was taking the drug Darvocet for over a year for pain in my elbow . I was taking the drug in I think it was 2007 in i believe 2008 my dr. took me off the Darvocet cause I was having a recation to the drug,, I was itiching really bad. So aifter a few years of my heart doing weird things, I went to a heart dr. last year,. I had a lot of test done and I was told I have NSVT. So I dont know if this is cause by the drug darvocet. There is no history of heart problems in my family.
Could my baby have developed ITP platelet condition from this medication cause I was on that and Zofran my entire pregnancy
I took Darvocet after a surgery in 2010. I have had a heart aruthmia ever since. I’m going to the cardiologist today because outs gotten worse and I’ve had some scary episodes. I’m an active person who exercises and eats healthy so I’m not sure why I’m having more issues but I believe it’s due to the heart arythmia from taking Darvocet. I hope no one else head to deal with this and its heart breaking to hear people have died from taking this drug too.
The first time I had Darvon N100 was in 1969. I was pregnant and got a really bad kidney infection that was very painful. It helped a lot. I never had it again til 1988 when my knees started swelling and turning red and hurting really bad. They gave me huge bottles of it and a bunch of refills. I learned it was Rheumatoid Arthritis causing it. Darvon gave way to Darvocet and it worked great for the RA pain. Then they took it away and I have worked my way up to Oxycodone 15mg 4 times a day. It does not touch the RA pain. It helps other pains I have but not the RA pain. I would love them to put the Darvocet back on the market and leave up to us and our doctors whether we take it or not. I never had a problem with it or my heart though I took it for decades. I hate when they mess with stuff that works