The FDA announced on Friday that drug maker Xanodyne Pharmaceuticals, Inc. has agreed to remove popular pain killers Darvon and Darvocet from the US market due to serious heart problems including fatal heart rhythm abnormalities. The Darvon and Darvocet recall currently only involves the name-brand medicines although the FDA has asked generic manufacturers of propoxyphene-containing drugs to remove their products as well.
According to the FDA's Darvocet recall announcement, Darvon and Darvocet and several other medications contain propoxyphene, which is an opioid used to treat mild to moderate pain. The medication was first approved in 1957 and is used alone (Darvon) or in combination with other drugs (Darvocet). The FDA has received two prior requests to remove propoxyphene from the market. The FDA has asked doctors to stop prescribing propoxyphene to their patients and encourages patients currently taking the medication to contact their physician to discuss switching to a different medication.
Drug maker Xanodyne released its own statement on the Darvon and Darvocet recall / removal from the market.
Propoxyphene is known to cause the following side effects:
Consumer advocacy group,Public Citizen, petitioned the FDA in 1978 and again in 2006 to ban propoxyphene. According to Public Citizen's press release, propoxyphene - the active drug in Darvon and Darvocet - was banned in the United Kingdom nearly 6 years ago and in the rest of Europe nearly 1.5 years ago. When Great Britain banned Darvon and Darvocet it found that the usefulness of the drug "is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable." According to Public Citizen, more than 30 years of evidence shows that propoxyphene is not very effective, is toxic at doses not much higher than the recommended dose (because a heart-toxic metabolite accumulates in the body), and can be addictive.
More coverage of the Darvon and Darvocet recall:
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(c) Copyright 2010 Brett A. Emison
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I've been taking the generic Darvocet since 2006. What could happen to me since I've been on it this long? One - two tablets a day. It's like my body was so use to taking this, it didn't even help with the pain. Told my doctor this a while back, he would never give me a new script.
Pam,Thank you for reading. I am not a physician, so I cannot counsel you on medicine. I suggest you speak to your physician about the potential risks of Darvocet, the reasons why Darvocet was pulled from the market, and the potential impact the drug has had on you. If your doctor won't speak to you about, I suggest you get a second opinion. Noted side effects of Darvocet include those listed in the original post above.
The FDA’s decision to order Darvon and other propoxyphene-containing products removed from the market on November 19, 2010, comes 5 YEARS after the pain reliever had been banned in Great Britain and a YEAR AND A HALF after it was withdrawn by all other members of the European Union. While other countries were taking strong regulatory steps to protect their citizens, the FDA’s reaction had been to simply increase the warnings on its risks. Darvon and its sister drugs have had a long history of 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? This history is not unique. On October 8, 2010, the FDA announced that Abbott Laboratories would be withdrawing Meridia from the American market, 9 months after the weight-loss drug was removed by the European Union. Earlier, the FDA had only strengthened the warning on the drug’s labeling, cautioning its users about the risk of heart attacks and strokes. On September 23, 2010, the FDA decided to allow Avandia to remain on the market, while the European Medicines Agency decided to pull the plug on the drug in Europe. These decisions are somewhat reminiscent of the history involving the drug, Cylert, which was withdrawn by the FDA in 2005 because it was causing severe liver damage to children taking it for ADHD – eight years after it was withdrawn by Great Britain.This pattern of increasing warnings while other countries are removing drugs that do not belong on the market is only a small sample 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 United States as a result of an adverse reaction to prescription and/or nonprescription drugs – a number that can be cut in half. Changes need to be made and they need to happen now. And it has got to start by eliminating the insanity of drug companies conducting their own premarket studies rather than an impartial entity, such as the National Institutes of Health. For everyone who is in agreement with taking some action, I would urge you to go to the website, LINK and sign my petition to Congress demanding a change. Only if the citizens of this country speak in a strong and unified voice will we catch the attention of Congress and impress upon it the need for such a change.
What do I do now? Darvocet N 100 is the only pain pill that I can take that works for me. I do not take it very often, but when I have severe pain it is the only thing I am able to take that actually relieves my pain. I cannot take Advil, Aleve, Celebrex, or any NSAIDS as they cause nosebleeds and bruises. Also can't take percocet, vicodin, oxycodone, Tylenol with codeine, etc. I get sick from them and they don't work for my pain. I agree with a previous comment......why did it take 53 years to decide it is not good for us to take. Quite frankly....I don't believe it. I think some of the antidepressants and other pain pills are more harmful than Darvocet!
Nancy, I am not unsympathetic with your plight of looking for an alternative pain medication. But there is a reason why Darvon and Darvocet were banned in England almost 6 years ago. These drugs are toxic at doses not much higher than the recommended dose because a heart-toxic metabolite accumulates in the body. They are also somewhat addictive and have been LINKED TO MANY THOUSANDS OF U.S. DEATHS SINCE 1981, a large proportion of which were likely caused by cardiac toxicity, including the interruption of electrical conduction in the heart.It has been estimated that at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since the UK ban was announced. In a study out of Florida, it was determined that from 2005 through 2009, in Florida alone, 395 deaths were “caused” by propoxyphene, the active ingredient in Darvon and Darvocet. They also ruled that 78 percent of the Florida deaths caused by propoxyphene were accidental.Looking at the bigger picture, preventing deaths should be the overriding consideration when taking regulatory action. The reality is that because of the FDA's lax approach, thousands have died unnecessarily. I would thus urge you to go to LINK and sign my petition to Congress.
I have taken Darvocet for 10-15 years. One pill in the am keeps my arthritis under control for the rest of the day. There are always people who abuse drugs.....I am sorry, but they must suffer the effects. I wonder how many people have a serious reaction to Penicillin yearly?? It is very difficult to legislate good behaviour....and the bad folks make us all suffer..........F Derrick
My Mom has been taking Darvocet(generic) for many many years. The same for her it is the only pain medication she can take that is not too strong that works for her. I am not sure if she should stop taking it. She only takes 1 - 2 a week.
This is very interesting. I asked my doctor for a cheap painkiller that would not be addicting like Hydrocodone or Oxycodone because I have had issues with them in the past. He prescribed me to Darvocet and the first few times I took the pills it made my chest hurt. I thought maybe it was heart burn or something to that nature. But now based on what I have read I think differently. For all the people who say they take one-two a day: THAT IS ALL IT TAKES. All drugs effect everyone differently but based on the fact it is now BANNED in multiple countries I would suggest finding an alternative. I took my recommend doses when I experienced this and honestly am a bit freaked out about it now.
I went to see my doctor on Dec.10,2010. He asked me if I had any Darvocet left? I told him I had gotten rid of it.He said there was nothing wrong with it, that I still could of taken it.He asked if it was helping with my pain. I told him when I first started taking this in 2006 it helped,but,the more I took it didn't even faze me any.He said why did you take it? I said you wouldn't give me anything else.So, now he gave me Gabapentin 300MG twice a day.He said there's no side affects for this. I read up on this, it causes back pain, which I already have.Why would I want more pain? When I did take Darvocet there were times when my stomach hurt so bad I couldn't move.Doctors do not listen to their patients.And now days you have to have insurance to see the good ones.
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