Public Citizen Urges FDA to Issue Darvon and Darvocet Recall
June 22nd, 2008 • Filed Under: News • 21 Comments
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.
Pingback by Darvocet Lawsuits — AboutLawsuits.com on 22 June 2008:
[...] 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 [...]
Comment by SANDY on 9 October 2008:
i suffered cardiac deppression hallucinations and seizures, and lost my job…
Comment by Sue on 7 November 2008:
I am a true beleiver that this medication is dangerous.
Comment by Micheal on 7 November 2008:
This medication causes major depression and I feel that it could cause a person to due serios harm to themselves.
Comment by D Ricks on 30 January 2009:
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
Comment by Yvonne on 31 January 2009:
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
Comment by Eleanor on 31 January 2009:
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.
Comment by YVETTE on 31 January 2009:
I HAVE BEEN TAKING DAROCET FOR ABOUT 5 YEARS FOR PAIN,I HAD A HEART ATTACK ON 04/17/08,I BEEN HAVING PROBLEMS EVERY SINCE MY DOCTOR DO NOT KNOW WHAT IS WRONG WITH MY LEFT LEG,IT IS ALWAYS HURTING MY EVERY SINCE THE OPERATION I HAVE BEEN HAVING TROUBLE.IT COULD BY THIS DARVOCET I HAVE ALL THE SIDE AFFECTS FROM THIS MEDICATION.
Comment by bill on 31 January 2009:
I can’t take Ibuprophen or any of the NSAIDS & suffer pain…This was the best alternative. leave it alone.
Comment by Lynn on 1 February 2009:
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.
Pingback by Recall of Darvocet and Darvon Recommended by FDA Panel : AboutLawsuits.com on 2 February 2009:
[...] FDA advisory panel voted 14 t0 12 to recommend a recall of Darvocet and Darvon, as the benefits did not outweigh the [...]
Comment by Nancy on 3 February 2009:
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.
Comment by Janice on 3 February 2009:
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.
Comment by lyel & barbara on 7 February 2009:
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
Comment by Rae on 15 February 2009:
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 http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2006-P-0270
by clicking on the little yellow dialogue balloon on the bottom right corner of the page.
Comment by Dr Ulf Jonasson on 19 February 2009:
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
http://www.youtube.com/watch?v=vw5O4tgErsg
Comment by Sam on 20 February 2009:
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.
Comment by Sandy on 7 April 2009:
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.
Comment by Kirk on 17 April 2009:
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.
Comment by Oswald on 29 May 2009:
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.
Comment by Roni on 30 June 2009:
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??
DO NOT DO THIS TO RHEUMATOID SUFFERRERS–THIS DRUG IS A TREMENDOUS HELP!!