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FDA pulls common pain med off the market (OT)

Posted by on Nov. 21, 2010 at 2:23 PM
  • 7 Replies

FDA pulls common pain med off the market

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.

by on Nov. 21, 2010 at 2:23 PM
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Replies (1-7):
Roadfamily6now
by on Nov. 21, 2010 at 2:57 PM

BUMP!

Pandapanda
by on Nov. 21, 2010 at 3:06 PM
Oh yuck! I know a lot of people on them!
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truealaskanmom
by on Nov. 21, 2010 at 4:44 PM

wow 

palemoon21
by on Nov. 21, 2010 at 11:35 PM

Is there a site that shows ALL the meds that contains this? (generic and brand names)

DixieFlower
by on Nov. 21, 2010 at 11:46 PM

This is what I found on drugs.com

Medications containing propoxyphene:

propoxyphene systemic

Brand names: Darvon, Darvon-N, PP-Cap
Drug class(es): narcotic analgesics
Propoxyphene systemic is used in the treatment of:

Multi-ingredient medications containing propoxyphene:

acetaminophen/propoxyphene systemic

Brand names: Darvocet-N 100, Darvocet-N 50, Darvocet A500, Balacet
Drug class(es): narcotic analgesic combinations
Acetaminophen/propoxyphene systemic is used in the treatment of:

aspirin/caffeine/propoxyphene systemic

Brand names: Darvon Compound-65, Propoxyphene Compound 65, PC-CAP, Darvon Compound 32
Drug class(es): narcotic analgesic combinations
Aspirin/caffeine/propoxyphene systemic is used in the treatment of:

Quoting palemoon21:

Is there a site that shows ALL the meds that contains this? (generic and brand names)


doulala
by Gold Member on Nov. 22, 2010 at 3:37 AM

ahh--

Thanks for sharing!

gypsyjewels
by on Nov. 22, 2010 at 11:41 AM

One of the BIGGEST reasons I don't trust man made drugs. 

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