Darvon and Darvocet, the brand name versions of the pain medication propoxyphene, are being withdrawn from the market in the United States. Their maker, Xanodyne Pharmaceuticals, has agreed to comply with the FDA's request to withdraw the drugs. Generic manufacturers of drugs that contain propoxyphene have also been notified and asked to comply.
Darvon was originally developed by Eli Lilly & Co., and has been on the U.S. market for more than 50 years. Eli Lilly & Co. later developed Darvocet, combining Darvon with acetaminophen. These drugs are commonly prescribed to treat mild to moderate arthritis pain.
There has been talk of taking these drugs off the market for years. Since 1978, the FDA has received two requests to remove propoxyphene from the market. But, until this point, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the risks. Why the change? A study has now shown that, even at recommended doses, propoxyphene can affect the electrical activity of the heart -- increasing the risk for serious abnormal heart rhythms that can lead to serious side effects, including death.
This news hits close to home for me. I have taken darvocet on a regular basis for over 20 years. It has been the most effective drug in my regimen for pain control. Just as I will need to do, patients who take propoxyphene-containing medications need to contact their doctor to discuss the withdrawal and the need to switch to another medication for pain management. Patients are being advised not to stop the drug without discussing how to do so with their doctor.
If there is any bit of good news -- reportedly, the changes to the heart's electrical activity are not cumulative. Once long-time users stop taking propoyphene, the risk is over. Read the FDA Press Release about the withdrawal of propoxyphene.
Related Resources:
- 10 Things You Should Know About Darvocet
- The Facts of (Analgesics) Painkillers
- When Are Pain Medications Appropriate for Arthritis Patients?
- Ways to Manage Your Pain
- How Does FDA Decide a Drug Should Be Withdrawn?
Join the Discussion:
It seems like this is throwing the baby out with the bathwater. They didn’y say all patients will encounter this problem and for many, this medicine is their best choice. I can’t take many pain medications because of the side effects, this was one I could take. I use brand x now, which is not as effective Darvocet-N on the pain I have. There are many drugs with potentially lethal side effects, yet they available.
I know I can’t take the big 2, this leaves me experimenting with drugs I may or may not be allergic too. But thats ok with the FDA?
Maybe it’s time for a more natural approach to pain management, particularly for long term conditions as opposed to acute pain. Here is a great article about the Darvocet recall and alternatives to pain management: http://biovedawellness.com/2010/11/fda-pulls-painkiller-medicine-off-the-market/
The present warning included with propoxyphene states you should not stop taking it abruptly, but should slowly reduce dosage over time to avoid any complications. All pharmacies I have called are no longer filling prescriptions. Is this considered safe???
taking drugs and their potential side effects was a constant source of worry to me as a rheumatoid arthritis sufferer. It was with great relief that I eventually found a natural solution to the problem. Previously, I could not exist without the prescribed anti-inflammatories and pain killers, and had to take them regularly just to be able to get out of bed and have some mobility of a day (and get to work). These drugs were not the total answer……I didn’t like taking them, and tried to keep doses low, so I was always in pain! I discovered a diet that helped me reduce the symptoms completely. I am not cured, because if I stray from the diet the symptoms return. I have been on the diet for many years now, it is no “freak”, it does work. Please see http://www.arthritis-solutions.co.uk for more information.
Unbelievable…because there MIGHT be a CHANCE that there will be an electrical change in some folks’ hearts, an effective, non addicting pain relief drug is being withdrawn from the market. And of course the vultures are moving in for the kill…i saw an ad that asked if you had had a heart attack; if so call 1-800 xdarvon because a lawsuit was being formed.
Better the FDA should withdraw any and all alcohol products – there is NO question that alcohol is addictive, causes all kinds of physical problems (e.g. liver problems) and is the indirect and direct cause of many deaths (alcohol poisoning, driving while drunk, etc). We all know that will never happen…More people die every year from alcohol than from Darvon/Darvocet, but alcohol will stay legal and approved while a mostly safe and effective medication is being withdrawn from the market. There is too much money involved in the alcohol industry.
The FDA is loaded with hypocrites.
For every person that insisted on withdrawal of darvocet/darvon, I wish a lifetime of unremitting pain – that only darvon/darvocet could have relieved. It seems only fair that the people who caused the removal of these drugs get to suffer along with the rest of us who depend on the meds to relieve our pain and who now need to go through the process of finding another pain med that will be as effective as the darvon/darvocet.
Yeah, I am bitter. The people who make these decisions are totally insulated from the results of their ill-considered decisions, and those of us affected have no voice and no say in the matter. Two words…INFORMED CONSENT. I know trhe risks and choose to use the meds anyway.
The FDA’s decision to order Darvon and her sister drugs removed from the market comes 5 YEARS after the pain reliever had been banned in Great Britain and 1 1/2 YEARS after it was withdrawn by the European Union. While other countries were taking strong regulatory steps to protect its citizens, the FDA chose simply to increase warnings. Darvon has had a long history associated with drug addiction, suicide and cardiac problems since first entering the market in 1957. My question is this – why should it take 53 years to determine that a drug should not be on the market?
The pattern of increasing warnings while other countries are removing drugs that don’t belong on the market is just another example of why our FDA and its oversight of drugs is no longer the gold standard of the world. Meanwhile, thousands of Americans are dying unnecessarily. As many as 230,000 per year die in the U.S. as a result of adverse reactions to prescription and/or nonprescription drugs – A NUMBER THAT CAN BE CUT IN HALF.
Changes need to be made and it has got to start with eliminating the insanity of drug companies conducting their own premarket studies rather than an impartial and objective entity. For those who are motivated to take some action, I would encourage you to go to the website, http://www.FDAreformpetition.com and sign my petition to Congress. Acting together we might just make a difference.
Terrence, the petition is for the future, yes? Is this for better regulation, more for the consumer than for those that seem to know best for us? I am sorry but I haven’t had time to read this.
I am very upset about the recall as I am one that has found relief as well. I have 3 compression fractures, spinal stenosis, and numerous arthritic problems…I have found some relief and able to function using this medication.
Is there any talk of them putting this back on the market? Is there anything that we as the consumer can do? Maybe they can put it back on with stronger warnings, or have people to sign for it? I am just so upset…:( I cannot take sulfa drugs, cannot take codiene, no vicodin, and do not want to take anything stronger. I am a single mom and need to function. I am a senior in college working towards my psychology degree and need to be able to do this. Please let me know if there is a petition I can sign to help get this reversed. I will help in whatever way I can.
I have a severe, intermittent pain in my neck. I found out by accident that Darvon stopped the pain. Like others I am very sensitive to many types of meds. I have been taking Darvon for just about six years. I did not have any at the recall time and have had 3 really bad days since. Is there anything comparable?
Everyone is being advised to discuss alternatives with their doctor. I have to do that myself this week.
DITTO to what Wendy says. I have taken first darvon and then darvocet and finally generic for forty plus years. I have often stopped and restarted and sometimes go several days without and then have to use three or four per day. I have never knowingly had side effects and this drug has not diminished its effectiveness over time. My heart is fine,I am sixty four and I use it for pain of headaches, myalgia and diabetic neuropathy. It works and does not bother my stomach. As a diabetic I have blood tested every three months and liver etc have not been harmed. I have been given loratab which is not as effective, has stomach side effects and who knows what else. This is great leave oxycodin on the shelf, which is abused and can cause heart failure and take darvocet off…….John P
I too am upset about the darvocet recall. I have severe osteoarthritis of the spine and shoulders along with peripheral neuropathy and headaches. I am unable to take most pain meds and alternative meds. Darvocet is one drug I can take without adverse side effects. It reduced the pain to the point where I could still be fairly active, which is very important for arthritis sufferers. I have read the fda pdf files and the evidence is just not there. Most drugs have side effects. I am an informed consumer and should be able to make an informed choice. I URGE ANYONE WHO OPPOSES THIS RECALL TO GO TO THE FDA WEB PAGE AND CLICK ON CONTACT INFO TO EMAIL OR CALL WITH YOUR CONCERNS!! If they hear from enough people maybe they will reverse their decision and at least be more aware in the future of those they are effecting.
EVERYONE CONTACT THE FDA. THIS IS INSANE. ASK FOR IT TO BE PUT BACK ON SHELF OR FOR THEM TO REMOVE OXY’S
I agree with most comments about this ridiculous decision probably made by people who have no clue how chronic pain sufferers will be affected. My husband has taken this since he lost his leg in Vietnam, and other pain killers he has used leave him with side effects or barely able to function.
We will certainly send our objections to the FDA! The risks that accompany use of this drug are acceptable to those like my husband who can only find releif with Darvocet!
I also have been on darvocet for 15 yrs and all at once none! I can’t function now with the pain and the only thing the Doctors can come up with is Tramadol! NOT even close! It makes me tired and does not help the pain!
I am 66 years old. All the medication that I am on for hypertention has a possible side effect of irregular heart beat. Darvocet is the only analgesic that relieves my muscle and joint pain when it becomes severe. If the only other choice is a heavy narcotic such as oxycontin or vicodin, then let the pain begin! These narcotics are not a viable alternative to darvocet. Now what do we do? Carol
I searched FDA papers, I did not come up with a paper that stated people are dropping dead of heart attacks, I DID however find a few papers that stated they pulled Darvocet because people that attempt suicide are more likely to succeed with it. That people have succeeded, and they are people that were already clinically diagnosed with severe depression and suicidal tenancies. People like this will find a way to carry out their deed with or without Darvocet. Why do people in pain that nothing else works for them be subjected to pain because a few people want it off the market. I imagine these people that wanted it off the market never had life altering pain and couldn’t take anything else.
Seriously, if the FDA is up in arms about heart trouble with medications, they need to seriously look at Viagra and others like it that are meant for hard ons. (Viagra is for certains kinds of heart patients, but it can cause attacks in others) I mean COME ON! “Erectile Dysfunction” is more important then chronic pain suffers, cancer patients, back pain sufferers etc?!?!?!…
There is no viable alternative to Darvocet.
I don’t know what the FDA is thinking! I take – took – Darvocet for bone, muscle and nerve pain left behind from heavy chemotherapy.
I didn’t take more then prescribed. Darvocet is the only thing I could take. Morphine makes me sick to my stomach, doesn’t take away the pain, but makes me feel like not bothering to talk about it. Vicodin is a joke. Doesn’t take away pain, but gives me severely jacked up dreams. Now I’m on Tramidol which is also a joke. I get pain relief for 8-10 seconds every 5 minutes or so (not joking, I counted!) I lay in bed at night and cry because the pain gets so bad I can’t fall asleep…. there is nothing else I can take. We need a petition! (one that has proper grammar and spelling would be very helpful).
Dear God, please bring Darvocet back.
And another question…. who is this “Group” that had a petition to take it off the market? I keep seeing the word “group” but never WHAT group…. WHO initiated it? Who do we contact?
I started a new petition!!!!!! For those suffering in pain… Sign here so we will be heard.
http://www.petitionspot.com/petitions/bringbackdarvocet/
I’LL TELL YOU WHO IS HAPPY ABOUT DARVOCET BEING REMOVED FROM THE EQUATION, THOSE PEOPLE WHO ARE ABUSING NARCOTICS. NOW THEY CAN SKIP THE OFFER OF DARVOCET AND GO STRAIGHT TO OXYCONTIN AND VICODIN.
I CAN’T HELP BUT THINK THAT SOMEWHERE ALONG THE LINE THIS IS ALL ABOUT MONEY.
I think the FDA’s decision is ridiculous! I’m a person with severe multiple documented medication allergies, including aspirin, Tylenol and codeine. This leaves me with few choices for mild pain relief. Darvon is really the only medication I can take. When I first heard that the recall was a possibility, I emailed the FDA and was told, “point-blank” that it was not going to happen. What a lie that was!! When the recall was announced, I emailed the FDA again and, big surprise, they never answered!! So now I’m left taking Morphine for a simple headache or a sprain. Does that make the FDA happy??!! What are those like me supposed to do?
This is or was ridiculous for FDA to do this without any real notification and consideration of thousands who take this med with no problem those of you who have any info on where i can still get this med or something very very simular contact at mattm180@yahoo.com i am contacting FDA on steady basis to voice my opionion let’s not give up until they come back to common sense
What……. has everybody given up? I’m still in the fight and would like to hear from others contact at mattm180@yahoo.com
Darvocet was the only thing that helped me for 15yrs. After going nuts finding out I can’t get it any longer. I now struggle with the side effects of all the drugs I have to sample before I will find one that works. And these drugs all state “that can cause death” including suicide !! Thanks FDA-Can’t even get the darvocet in Canada now. I’m a mess and in pain.
While I cannot take Darvocet (I’m probably one of those that have the problem because I have a rapid heartbeat when I take it), it is the only thing my mother can take.
She is in the same boat as MANY of you, allergies and oversensitivity make higher level Narcotics out of the question.
Due to not being able to take Darvocet because of the heart flutter/rapid heartbeat, I have lived in pain for 14 years over 2 slipped discs and a bone spur gouging into my sciatic nerve and take NOTHING for it.
My mom has had a knee replacement that failed, and her other knee is toast, and she is 74.
Darvocet was the ONLY medication that allowed her to function through her day. She never took it according to directions, she always took LESS.
It seems to me that those who have been affected negatively by this recall are the smart ones who are concerned about addictive potential, and should NOT be having to suffer over one or two people having an allergic reaction to the medication.
It was probably one very rich person who had a family member die from the allergic reaction and threatened to shut down the FDA that caused this problem.
I feel all your pain, literally, and I will help in whatever way I can to help my mom AND you.
If there’s a petition, bring it on!
I too am upset about this whole thing. Now the doctor prescribes vicodin which doesn’t work anywhere near as well and I have to take a lot more of it because it’s highly addictive and yesterdays dose won’t work at today’s dose so I just ultimately suffer. On top of it, they got rid of the only brand for vicodin that worked, the Watson brand. Now what they have available like Quest is the same thing as taking only tylonel and taking more vicodin to relieve pain because it’s not as potent can kill your liver. I didn’t ever have to increase the dose with darvocet. Small doses always worked. Alcohol and any other drug on the market all have side effects and they can all kill someone so why did the FDA focus on darvocet? Anyone who has to take vicodin, percecet or any of those drugs in place of darvocet might even get accused by the doctor of abusing them because you HAVE to take more to get the same relief for pain. I know it’s just a couple of people who lost a loved one who abused or overdosed purposely and died.
What about all the people who have lost loved ones to alcohol or them being hit by a drunk driver or any other way you die from alcohol which kills more people than anything else and there is no theurepeutic need for alcohol and it’s OTC but if you go to the ER, the worst drug, point blank, that they see is alcohol. If we’re going to take darvocet off the market, alcohol, cigarrettes and just about every drug out there, even tylenol, needs to go, or else there is no legite reason to take darvocet off the market. They need to put it back on the shelves. While we’re at it, get alcohol off the shelves, no longer OTC.