12/8/10 If you are one of the approximately 10 million people who take the opioid painkiller propoxyphene, sold under the brand names Darvocet or Darvon, talk to your doctor about an alternative. The U.S. Food and Drug Administration, or FDA, has asked the makers of drugs that contain propoxyphene to voluntarily withdraw them from the market due to new evidence that they cause potentially fatal heart problems.
Xanodyne Pharmaceuticals Inc., maker of Darvon and Darvocet, which combines Darvon with acetaminophen, agreed to withdraw the medicines from pharmacy shelves. The FDA has asked makers of generic propoxyphene to do the same.
Propoxyphene has been around a long time; the FDA approved the opioid in 1957. “I think people liked it because people viewed it as not quite as strong as others [in its class], so it fit in for mild to moderate pain, not severe pain,” says David Pisetsky, MD, a professor of medicine at Duke University Medical Center in Durham, N.C.
But the drug hasn’t been without controversy. The FDA denied two public citizens’ petitions, in 1978 and in 2006, to ban the drug due to health risks. The government agency said medical reviews consistently found that the benefits outweighed its risks. In 2009, however, the FDA called for a stronger boxed warning on propoxyphene drugs and required Xanodyne to conduct a safety study to further look into the effects of propoxyphene on the heart.
Britain pulled the drugs five years ago because of concerns about the medication’s link to suicides and accidental overdoses. The rest of Europe did the same last year. But the FDA says it didn’t believe action was warranted until it received the results of the new safety study, which showed propoxyphene caused a risk of severe and potentially fatal heart damage and heart rhythm abnormalities.
“The data suggested that the heart risk of propoxyphene could apply to all users, and not just those who took excessive doses or those with medical conditions that might reduce their ability to clear propoxyphene from the body, such as patients with reduced kidney function,” explains John Jenkins, MD, director of the FDA Center for Drug Evaluation and Research. “I think what is unique here is that the new heart data show that the adverse effects on the electrical activity of the heart occur at recommended doses in normal volunteers and not just in overdose.”
The FDA is advising health care professionals to stop prescribing propoxyphene to their patients. The FDA says patients will no longer be at risk when they stop the medication, but need to consult a doctor before doing so.
Dr. Pisetsky says patients have other pain-management options. “This was not a unique product. There are certainly many, many opioids out there that can be used.”
Dr. Pisetsky says patients should talk with their own doctors to assess side effects of other medications and figure out what’s best for them.
“It’s important that physicians and patients have conversations,” Dr. Pisetsky says. “There’s a large menu of things you can try short of medication. And then with medication, you look at what’s the safest and most effective product you can prescribe.”
I too took Darvocet for years and it helped my foot pain immensely however the risks to my heart are clearly not worth dying over. I'll take the pain over death.
Hindsight is 20/20 so I'm glad the FDA removed it from the market. i have not had any heart related incidents since stopping Darvocet in 2010.
I am on Vicodin and it does not stop my pain at all. I'm allergic to codiene and tramadol as well as Ultram. I will be having foot surgery this summer and dread what the pain will be like without darvocet to take the pain away. I'll be having a long talk with my surgeon about stronger pain meds for sure!
I do hope they find a safe drug like darvocet.
Will anyone stand up for those of us who don't have a "voice" in this? There are millions of people suffering right now, because the FDA did this. We can't afford all the doctor appts trying to find an alternative. Most of the newer pain meds are expensive and loaded with much worse side effects.
Treximet is clearly marked with a possible side effect of "death"!
We just want to function, to live, to be part of life. Some of us may have to make the hard choice to go on disability because of the Darvocet recall. This could affect the economy more than they ever realized, because Darvocet kept us able to work!
Please, FDA, have compassion on the millions of Americans with chronic pain. Re-release Darvocet... with warnings! We're not stupid. We can make our own choices.
old...I took it for pain, and it has followed
me into my adult life once I was diagnosed
with RA. I cannot tell ANYONE how I took the
news of it being removed from the market.
I am now 65 years old, just had a stress test
and EVERYTHING LOOKS GREAT...no signs of my heart experiencing any 'problem' and I have
been taking it for 44yrs. I am like the above reader, and wish there were something I
could do to protest. Maybe someone could look into having as a requirement to TAKE IT,
to keep checking the heart via EKG, to look for abnormalties. All I know is the pain
medicine I have taken almost all my life, is
now gone and I am taking Hydrocodone 5/500
now as it's substitute and it doesn't work
anywhere as well as the Darvocet did. I wish
someone could have warned us about the prospect of it's discontinuance...I would stocked up. Too late now....
I have had OA since 1998 and felt very frustrated when Bextra was recalled because it worked very well for me.(I cannot take Codeine or percocet). I talked to my rheumatologist and there were other options. I tried Tramadol combined with Acetaminophen which works very well for me. A physical therapist taught me modified yoga, pilates, & massage. There is a topical cream that has been very helpful.
it's so obvious that everyone represented here is so very careful not to take more than we need.
and it is obvious that it really doesn't matter how many other drugs are available for pain. just because those drugs and other therapies are available doesn't mean they will help each person or that each person will be able to tolerate them.
i wish i knew what we could do. i will be researching that....i have no idea if the american pain foundation is acting on this. this morning's newspaper carried a story about how vicodin may be next. it's obvious our voices need to be louder and be heard.
i've been disabled since 1990 and feel that in general the chronic pain and disabled communities are ignored and seen as disposable. now it almost seems like we are under siege.
i'm sorry for those who have developed heart problems because of darvocet. now that we know that can happen, could the answer be simply more close monitoring???
i also read tylenol is still under attack because too much can harm the liver. well please don't take that, too, because some people take too much. there will always be people who take too much.
sorry to ramble....i'm just thinking out loud.
my problem is that i am allergic to aspirin, ibuprofen, codeine, and morphine. without the availability of darvocet, i have been left in a really difficult situation. well...you can imagine.
i recently moved to the desert in order to get the most out of my health. i would have gladly signed a waiver in order to continue receiving darvocet. sometimes the harm being done in the name of good outweighs the potential for harm.
My advice to anyone with much pain...turn to low dose opiates(under the care of a Pain Management Physician). When I have pain I tend to turn inside. I don't like being snappy or rude, so better I sleep it off.
These auto-immune diseases are horrific. May there one day be a cure!
One final thought....smokers can still buy dangerous cigarettes. Not removed from the market, just strong warning added.
I tell you what will probably happen to me, and this is so sad. After knee surgery, that pain will be helped, but the Fibro nightmare will never end and progressively gets worse. So the only thing that might help is alcohol. I also have chronic cystitis (interstitial cystitis) and cannot handle that pain! Once while on a trip, I had no meds for it and medicated with vodka! It either helped, or I didn't care if it didn't! That it might happen again scares me, because pain reduction (or even calming it down) has become almost a basic life requirement for my life. Normally, I don't drink because I take alot of meds; but when I feel like the pain isn't worth living through....vodka doesn't sound so bad. Why are we treated so sadly by the medical community?? I am coming into the 20th year of pain, and I am about at my wit's end!
Frances
Judy
I feel it should be up to the individual to decide what drugs to take. A patient should always read all the warnings/side effects of all medicine when you pick it up from the pharmacy. Or ask the pharmacist or doctor if you have any questions about the drug. Then decide if it's worth the risk. I've taken Darvon and Darvocet many times in the past, as well as lots of other pain relievers. Nothing really takes the pain of my DDD away completely, but some meds do seem to ease it somewhat, making me more relaxed and less crabby.
I also agree that we need to stay positive and focus on something other than our pain. But that is extrememly difficult sometimes. I also use other methods for relaxation and find that prayer and meditation also help. Of course, there are many alternatives out there, besides drugs. I could write a book, as I'm sure many of us could!
I pray that someday soon scientists will find a medicine to help ease severe pain without dangerous side effects.
Can I get an AMEN ???
TOnie
Let's preserve my quality of life with medications that can help me. I might die of a heart attack even if I don't take one of these drugs. Certainly this issue is causing me stress!.
weather-maybe 20/month on average otherwise.
Made life liveable! This last 6 weeks has not
been fun at all. I did develop a heart arrhythmia about 4 years ago/take Metaprolol
for it. None of us put the heart problem together with Darvocet. But you know what/give me the Darvocet or else bring back
Vioxx/It all has to do with quality of life/I am still working full time as a nurse/
not in a hospital anymore/knees too bad, but
use walker and cane to walk. Used Oxycontin
a few times in 2001-only 10 mg, and it only
helped for a few hours/it lowered my blood pressure and made me nauseous, so that was the end of that/back to the Darvocet. People are right/we as adults should be given a choice once we have been given a full disclosure and understand the risks/ and all drugs do have side effects/it is always a crap shot whether we will suffer from them or
not. I vote for freedom of choice and an improved quality of life. EG/RN/BSN/RNC-Nic
Basically my doctor told me I'm just screwed because there is nothing out there for me except the heavy stuff and I'm not at all interested in that. Where is the help for people like me??
I also take Rituxin but I still need pain control on some days.
Why can't I make my own decision about my meds? All drugs have side effects too. I take remicade also. It has a lot of side effects. I have to decide what kind of life I want to live,preferably pain free.
Now I have no alternative. I have tried every other drug in existence, and only Oxycontin gives me any relief. I'd rather risk my heart than risk Oxycontin, but it seems I may have no choice now.
The government should not force these decisions on those of us facing quality of life issues. I do not look forward to my days anymore, faced with such pain.
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