Recall of Darvocet and Darvon Recommended by FDA Panel

UPDATE 11/19/2010: The FDA decided to recall Darvocet and Darvon in November 2010.

A panel of outside advisors to the FDA have recommended that the agency withdraw approval for the painkiller Darvon, which is also sold as Darvocet with the addition of acetaminophen. The panel found that the minimal pain relief benefits provided by the drugs do not outweigh the substantial risk of overdose, suicide and other known side effects of Darvon.

Although the FDA is not required to follow the advice of their advisory panel and issue a Darvon and Darvocet recall, the agency usually does what their panels recommend.

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The advisory panel met last week in Washington, D.C., to evaluate the safety of the drugs following a petition by the consumer advocacy group Public Citizen, which called on the FDA to ban the drugs because they have been associated with over 2,000 accidental deaths, are physically addictive and are no more effective than other safer painkillers.

In June, Public Citizen filed a Darvon lawsuit against the FDA alleging that the agency was violating the law by failing to act on the petition they originally filed in 2006.

Darvon, which was first introduced in 1957, contains propoxyphene to relieve mild to moderate post-surgical pain.

Today it is most commonly prescribed as Darvocet, which combines the active ingredient in Darvon, propoxyphene, with acetaminophen, the active ingredient in Tylenol. Darvocet has become one of the top 25 most commonly prescribed medications, and combined the drugs have been prescribed to more than 22 million people.

According to an analysis prepared by the FDA for the hearing, more than 3,000 serious reports of Darvon and Darvocet problems were identified, with most involving suicides, addiction and overdoses. In addition, the agency indicated that with Darvocet, the Darvon component provides little to no more pain relief than taking acetaminophen alone.

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


326 Comments


Jennifer
I, too agree with Sue, Kieth and a few others, especially Cindy. I take it for basically the same reason’s. I don’t get sick when I take Darvocet. At one point a pain management Dr. wanted to take me off it and put me on , of all things , Oxycotton. I told him , flat out no. So then he put me on a couple others that made me suicidal with a few days. So NO I won’t take anything but Darvocet.

Arzosa
I have fibromyalgia and just recently got released from the hospital from where I was being treated for a kidney infection. While in hospital i was given dilauded when released they said to get the perscription from my family doctor, and my family doc decides that darvocet is going to be just as good. Now you tell me this is going to cut it for pain? I think not. Vicodin doesn’t do anything and percocet makes me sick, but he says this darvocet is the miracle cure-all that will fix me. I think doctors are just perscribing whatever they have stock in, or can make their own money in, regardless of wether or not it helps or hurts us, just look at the issue with Methodone, kills 2 out of every 100 who use it but they still won’t pull that one either cause it makes too much money. I don’t think you people who are finding relief from your pain from this drug will have anything to worry about any time soon if that controversy is any indication, ao don’t fret your heads about it and to those of you who have a problem with it…it’s as simple as this…. STOP TAKING IT!!!

Susi
Every drug has safety issues. Nothing is “free”! But drugs are not interchangeable for people, either. If one works, such as Darvocet, that doesn’t mean even a very similar drug will work. I have taken many different pain killers (I only take them occasionally) and the only one that works without making me feel I am from Mars is Darvocet. I can take a very small amount and get some relief when it’s very necessary. Maybe Eli Lilly thought Darvocet would fade away when Cymbalta came out? since that didn’t happen, Lilly stopped “fighting” for Darvocet and (wink wink) the FDA has a newfound zeal for banning Darvocet? These facts made me wonder– http://www.associatedcontent.com/article/1438278/is_cymbalta_behind_the_new_fda_push.html?cat=71

Charles
So I guess my wife has to suffer because they decided that no one can be responsible to use the drug correctly. Darvocet is the only pain med that works with her. She had surgery yesterday and has just found out that she can’t get her pain meds. She is allergic to almost everything else on the market.

judith
I have severe arthritis, a herniated disc and am currently suffering with sciatica. Darvocet has been the only pain killer (other than Lortab) that has given me any relief. I hope they reconsider before taking this off the market. Tylenol??? please, that just doesn’t work for this kind of pain.

Dene'
I have suffered from intersitial cystitis for many years. My physician prescribed Darvon to me approximatly 16 months ago and I was almost immediatly pain free. With few exceptions, I no longer feel the daily discomfort that I have been tormented with for the better part of 12 years. Obviously the argument that the pain is being reduced because of the Tylenol is incorrect because Darvon does not have the Tylenol in it. I feel that the risk of sucide would be much greater if I had to endure the pain that I used to, prior to me being prescribed the drug. I certainly hope they don’t take it off the market

Charity
I was just prescribed this medication last night, and I have to say I was a little surprised at all of the questions they didn’t ask me. Apparently this medication causes a rise in suicidal thoughts and depression. The doctors didn’t ask me anything about my mental health status, and that makes me pretty reluctant to take it. I really feel the doctors dropped the ball on my whole hospital experience but that’s a discussion for the grievance I think I’m going to file. Anyway, if doctor’s are going to prescribe something that might make somebody suicidal, I think the main question should be if they have suicidal tendencies. I need the painkillers, but I think I’ll only take half of the recommended dosage and half an ibuprofen.

Keith
I am a physician, and I find this very, very disturbing. I know of many patients for whom one narcotic pain med or another doesn’t work, causes vomitting, etc. If Darvocet works for these patients, why should it be taken of the market?

sandra
My mother, 92 years old, has successfully used Darvocet for many years. She has severe bone pain and cannot medically tolerate surgery. Darvocet is the only effective pain reliever she can tolerate physically. She has had violent nausea and hives from fentanyl, hydrocodone, morphine and codeine. It would be a travesty to remove Darvocet because some people abuse it, when others have no other effective alternative for pain relief.

KC
Thank you Kathryn for your comments. I thought it was interesting that the person who complained about ignorance in our society (Tammy) seems to be the most ignorant and ill-informed of all posts here! She even contradicted herself claiming that addiction was an allergy . . . no, its genetic . . . no, wait its the environment. “. . . it’s common for an addiction problem to arise when the drug is no longer available” is one of the stupidest things I have ever heard. That is just dumb. If you are physically dependent on a drug and it is withheld, then of course your body is going to react but that is not the same thing as addiction. The comment that “Fentanyl should never have been marketed for use by humans . . .It’s 100 times stronger than morphine and it was developed as an anesthetic for large animals such as elephants and rhinos” further reveals this posters ignorance — each and everyone of these assertions is completely WRONG! Paul Janssen developed the drug for use in humans, it is 80 times stronger than morphine, and it is used extensively for anesthesia and analgesia. Also, in its patch form it is one of the most difficult opioids to abuse. The FDA, independent scientists, doctors and chronic pain patients all recognize that fentanyl is probably the best drug for the long term “control” of severe chronic pain. The only others comparable are oxycontin and methadone. Please don’t misunderstand me for I don’t disagree with Tammy’s entire post. With respect to the following I must wholeheartedly agree: “Obviously there are those who have nothing better to do than make a fool of themselves.”

Susie
I too agree that this medication should not be banned. I for one, benefit from it tremendously. My rheumotoid pain is kept under control. So now the only choice my RA doctor has is tylenol or tramadol. I have tried tramadol or ultram as known before, and it does absolutely nothing. Why punish those of us who need this medication and are responsible to take it as prescribed. For those who over use the medication, they will overuse other thngs just as much. They say one is good, two is better and three or more is even better yet, that is for those who overuse medication. Please do not ban this medication and punish those of us who use it as prescribed. Limiting physicians on how to treat their patients is hard on the physician and even harder on the patient. I would hate to see individuals going other places to seek relief of pain and not even knowing what they are getting themselves into. Again, please do not ban this medication. Thanks for listening.

kay
I agree with sue. I have been on Darocet for severe arthrits. I cannot take stronger medications because of the :drowsey side effects. Tylenol alone does nothing for severe arthrits pain,. Doctors are responsible for controlling pt medications. Taking this off the market will put pts on more potent narcotics which will cause more damage. If it were for this pain releif I would not be able to work I am 63 and my only support and do not want stronger pain medications. Please vote against this recall and make pts and their physicians accountable as they should be.You didnt quote the deaths from drug over doses from the other narcotics, bet they are thousand times more than this one.

kathryn
Hi the problems w/ Darvocet do not apply to all opioids as mentioned by Mackenzie . Mackenzie, you are so right that we should not be afraid to treat pain..just not Darvocet… As for Advisory panels–go to FDA website and you can learn about advisory panels. Many opioids do not have the lingering metabolite problems of Darvocet as most are short acting–some are made long acting by putting the medication in a time release delivery system .. Methadone is an exception–very long acting…We have opioids that are better suited for use in mild,moder-and moder-severe pain. They should be used, but often are not because many physicians are reluctant to treat pain with more effective, stronger opioids–DEA concerns personal concerns about lack of expertise (that can be changed) and even moral concerns about treating pain at all …… As for the comment about “allergy” and substance abuse–they are not the same thing.There are people allergic to all sorts of things ided-but substance abuse in general, has genetic components (see Human Genome Project at NIH) , psychosocial components, and should be part of another discussion– the term “allergy” is often used in a vague way and may need to be better explained in a substance abuse forum not one that is about intractable pain and its treatments as it assumes that treating pain creates addiction. The legit. medical treatment of chronic/intractable pain should not be lumped w/substance abuse, Tx should not only include opioid meds for intractable pain (or at times for acute pain), but tx should be multimodal w/ other meds, counseling, nutritional consults, PT, exercise, etc and should be ongoing in nature.All opioids will cause physical dependence. But that is not addiction. Addiction is another subject w/ its own set of behavioral issues… issues of aberrant use of a substance,and is a problem for sure, but should not be confused with the mgt of pain.. Tolerance can also develop in chronic pain pts. txed w/ opiods, but there are ways to manage that as well. Until we move away form treating legit chronic/intractable pain pts as drug addicts we will never have effective treatment for chronic/intractable pain.As for fentanyl–it is a useful drug (often used in anesthesia) and it is very useful for high level breakthru pain as it has an ultra short 1/2 life.. OTFC–transmucosal fentanyl–onset of relief in breakthru pain can relieveit as little as 5-10mins–and the drug is out out of the system completely within 2 hrs, but the effects of the drug are gone in about 45 mins.making it a viable alternative to an injection or expensive ER visit should a person using long acting ,daily opioids for intractable pain have a flare of higher pain.. Duragesic (fentanyl) patches–the membrane provides for slow release of the med is a lifesaver to many who cannot find relief from the kind of daily pain that if felt by a person who has no pain problem –the level of pain that intractable pain pts suffer daily would send the aver. person running to the ER if they felt that type of pain.. .

Cindy
I find this to be extremely disturbing. There may well be a risk of the problems that have beeen described, however, the “minimal pain relief” that is assumed is far from the truth. I have had many bone surgeries. Bone surgery is considered to be one of the most painful types of surgery to undergo. I am allergic to many of the families of pain killers, so after one or two days of injectable medcations in the hospital, the most effective pain killers that my doctor and I have found for this is Darvocet. It is not a be all/end all pain killer, but it is certainly more effective than a couple of Tylenol!! My mother has the same situation of being allergic to most pain medicines and has found Darvocet to be extremely effective for her pain. There are many medications that, when abused, cause severe side-effectsor death, but to ban all medications which have been used in this manner and to assume ineffectiveness of the medication simply to further your own cause seems incomprehensible. Fine, regulate the medication more closely, but do not remove one of the few truely effective pain medicines from the market simply because there are problems with controlling it. It is not true that the medicine causes “minimal pain relief” and it certtainly is not true that it is no more effective than Tylenol. Believe me, we have tried amny other medications including Tylenol and found none that were as effective post-operatively as Darvocet is! please, do not take it off of the market simply because your advisors have opinions that do not seem to be based on facts!!

Aimee H
Okay I think the thing about the this article is to say that for “some” not all, the darvon component does not work effectively and the pain relief is coming from the acetaminophen component found in tylenol. If the darvon component is addictive in nature and the findings are that it does more harm than good…than maybe it should be removed from the market. I have been on darvocet for the last 2 years for kidney stone pain and have found that it does not work 90% of the time…so I have stopped taking it altogether. It is for every patient to take their medical destiny in their own hands…

Mackenzie
I have taken Darvocet for over 15 years for arthritis pain prn it works well. The problems reported with this drug could be applied to all pain medication. We should not be so afraid to control pain.

kathryn
Many physicians like NSAIDs, Darvocet and meds that are nonsched. or sched. IV–they can treat around the schedule and their DEA licenses– and many elderly pts are given Darvocet , Ultram, etc as everyday meds to be taken daily.. My elderly father is given 500 tablets at time –and his family doc had no qualms about long term use–yes, the pt is responsible, but the pt’s responsibility is a shared responsibility– (my father reads about his meds and takes as few as possible) but he is not a medical professional–and his Dr, his pharmacist and even these middlemen PBMs share responsibility. Esp. the Dr.. If there is no need for professional counsel–why not have everything available as OTC w/ pts deciding “what is intheir best interest”. By definition, patients have limited training in medical matters and are often asked to make decsions without expertise–hardly a level playing field.if you are not formally trained in medicine,phcy,etc–and those that are so trained should not be treating themselves or their families…all meds are risk-benefit–but Darvocet appears to offer more risk than benefit across population study (epidemiological study)–within any given individ. maybe a person finds relief– potential cardiac toxicity, accumulation of metabolites and potential for mental confusion etc in elderly whose clearance of repeated medications may be poor– seems to be a poor trade off for a medication that is no better than plain aspirin or Tylenol for most pts in terms of pain relief.

craig
Darvocet is commonly prescribed in the elderly population due to its milder effects compared to stronger narcotics such as percocet or vicodin. This may be why we are seeing overdoses in such large numbers. Older patients may become confused and accidentally take too many. I fear that with the recall of Darvocet, more elderly patients will have to go on percocet or vicodin which could lead to INCREASED confusion and even MORE potential for adverse events.

Mary
Maybe when the physicians stop handing out medication like candy?

keith
I agree with Sue this med. is THE only med. i have found to work great for me and my back and leg pain. PLEASE DO NOT BAN THIS MED. PLEASE.

Tammy
Ignorance abounds in our society. There’s no such thing as an ‘addictive personality’. That is a term invented by someone who is clueless about the disease of addiction – regardless of one’s chosen ‘poison’. It is also an allergy. Certain substances cause an abnormal reaction in the body called ‘cravings’. It’s a disease of both body and mind. An alcoholic/addict does not set out to be that way. They are born with it. It’s cause is genetic. Environment has a role in it as well. Both are a common thread. Anyone who takes opiate based medications (Darvocet being one of many) over a long period of time even if it is only ‘as needed’ becomes dependent on it. While one is taking the drug it’s not a problem. However, it’s common for an addiction problem to arise when the drug is no longer available and many drugs require tapering off over time. Some require detox treatment in those with or without the disease. Fentanyl should never have been marketed for use by humans. It’s 100 times stronger than morphine and it was developed as an anesthetic for large animals such as elephants and rhinos. Addicts take responsiblity for their disease once they recognize it for what it is and seek help through others who have been there and are recovering. There is no cure. It stops when a life becomes more important than money I can’t help but wonder why someone would even bother to come to this site unless they or someone else in their family haved either died or been permanently harmed. Obviously there are those who have nothing better to do than make a fool of themselves.

Nancy
I agree with Sue, What is wrong with the people taking responsablity for themselves? I have been on Darvocet since I was 28 and now I am 54. I only take it when I can’t stand my pain anymore and it takes the edge off. I have RA. My hubby also takes it. He has Diabetes and bad kidneys. His legs hurt most days and he only takes it when he can’t stand the pain. We have been sharing a bottle of Darvocet 30 pills for well over 6 months now. I sure hope they find something that works as well when this comes off the market. I guess I could start on booze.

Ed
Who was on this “advisory panel?” How many were connected to Public Citizen? Who authorized Public Citizen to speak for us all? 3000 instances of “suicide, overdose, and addiction” in over 50 years of use? How does this compare to all other medicines of any kind? Who is the maker of this mole hill made into a mountain? The FDA seems to be missing the “big ones” and focusing on the little bits.

Speaktruth
Sue – The reason it’s being challenged is NOT because it’s great but weak people abuse it – Its being challenged because it doesn’t work, but it’s addictive, and can cause depression / suicide. Your mom can take something else – or just take tylenol – that’s what’s working anyway.

Sue
So I guess expecting patients to take responsibility for the usage of their own medication is asking too much? My Mother has been using Darvocet for years…when needed. Might as well recall a drug that has helped 22 million people because a few can’t read the directions on the bottle. Maybe the physicians should examine the mental health of their patients as well as their physical health prior to prescibing. If “getting addicted” to something that can hurt you is the concern–you better start recalling all drugs and alcohol, greasy hamburgers, candy, donuts, spicy food, and anything else that can be ingested in excess and do harm. It is the addictive personality that is the issue, not the drug. Where does this all stop?

Darvon Lawsuits : AboutLawsuits.com
[…] of deaths and is very addictive. On January 30, 2009, an FDA advisory panel recommended that a Darvon recall be issued because the risks outweight the minimal benefits provided by the […]

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