Washington (CNN) -- The pharmaceutical company that makes the prescription pain medications Darvon and Darvocet has agreed to withdraw the drugs from the U.S. market at the request of the U.S. Food and Drug Administration, the FDA said Friday.
The FDA says the drug, propoxyphene, puts patients at risk of potentially serious or fatal heart rhythm abnormalities. Since 2009, 10 million people have been prescribed some form of the drug.
"We recommend to physicians stop prescribing the drugs. As for patients, do not stop taking it, but we urge you to contact your health care professional. Do not delay," said Gerald Dal Pan, director of the FDA's Office of Surveillance and Epidemiology.
Xanodyne Pharmaceuticals Inc. manufactures Darvon and Darvocet, two brand name versions of propoxyphene. The FDA also asked generic makers of the pain medicine to voluntarily remove their products.
The decision to remove the drug came after the FDA reviewed a new trial study that looked at the drug's impact on heart rhythms.
"The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks," the FDA said in a statement released Friday.
Propoxyphene, first approved by the FDA in 1957, is an opioid used to treat mild to moderate pain. It is sold under various names both alone, such as Darvon, or in combination with acetaminophen, such as Darvocet.
Since 1978, the FDA has received two requests to remove propoxyphene from the market, but concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks. -
Posts: 48021 | From Tree House | Registered: Jul 2007
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posted
I don't take darvocet or any of its' cousins, but thank you for the warning Keebler!
Posts: 624 | From Oklahoma | Registered: Jun 2010
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That's pretty strange since Darvon has been around at least from the early 70's or before.
Took them 40 yrs to figure this out?
-------------------- --Lymetutu-- Opinions, not medical advice! Posts: 96239 | From Texas | Registered: Feb 2001
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lululymemom
Frequent Contributor (1K+ posts)
Member # 26405
posted
Wow... very good information! Took darvon for 3 years off and on it might explain why I ended up in the hospital with a heart rate that was so fast it wouldn't register on the monitor..
They were considering defib, until it finally got under control. I never made the connection till now..
posted
I took it a long time ago for migraines. My mom used to take it for migraines too... back before they came out with "real" migraine meds.
-------------------- --Lymetutu-- Opinions, not medical advice! Posts: 96239 | From Texas | Registered: Feb 2001
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linky123
Frequent Contributor (1K+ posts)
Member # 19974
posted
Well, thanks alot! It's the only narcotic I'm not allergic to and I've never had any compications from it.
My mother took it for quite a while for arthritis pain and no problems there either.
I guess if the research bears it out, better to be safe than sorry. I've had some major dental work done lately - cavitations and root canals pulled. Guess I'll have to make it throught with Ibuprofen. Great!
-------------------- 'Come to me, all you who are weary and burdened, and I will give you rest.' Matthew 11:28 Posts: 2607 | From Hooterville | Registered: Apr 2009
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posted
My sister had sent me this information, after I saw it here. Her DH has been dealing with heart issues for some time now. And he was taking Darvocet......wow.
I remember my mother taking Darvon for migraines as well (I remember them being pink..this was a LONG time ago). And yes, I'm wondering as well..they're JUST NOW finding this out?
Posts: 624 | From Oklahoma | Registered: Jun 2010
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Keebler
Honored Contributor (25K+ posts)
Member # 12673
posted
- They've known this for quite a while, actually. -
Posts: 48021 | From Tree House | Registered: Jul 2007
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