spini4
Bluelighter
- Joined
- Nov 18, 2003
- Messages
- 795
By MATTHEW PERRONE
The Associated Press
WASHINGTON — The maker of the painkiller Darvon is pulling the drug off the market under pressure from public health officials who say it causes potentially deadly heart rhythms.
The Food and Drug Administration said Friday that Xanodyne Pharmaceuticals has agreed to halt marketing of Darvon and the related brand Darvocet, which have been subject to safety concerns for decades.
Three studies by McGill University researchers presented at the annual meeting of the Society for Neuroscience on Sunday show that the way we navigate the world today may indeed affect just how well our brains function as we age.
The FDA has also called on generic drugmakers to stop marketing low-cost drugs containing the active ingredient in Darvon, called propoxyphene.
About 10 million people in the U.S. received prescriptions for Darvon and related drugs in 2009, according to the FDA.
Friday's action puts the U.S. in line with Britain and the European Union, which previously decided to ban Darvon due to suicides and accidental overdoses.
FDA officials said they decided to take action based on a recent study showing Darvon interferes with the electrical activity of the heart, causing irregular heart rhythms that can be fatal.
"With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart," Dr. Gerald Dal Pan, director of FDA's office of surveillance and epidemiology said in a statement.
Dal Pan said patients taking Darvon should continue taking the medication until their doctor prescribes a replacement therapy. Other commonly-prescribed opioid drugs for pain include oxycodone and morphine.
Darvon, which was first approved in the 1950s, is an opioid narcotic used to treat mild to moderate pain. The consumer watchdog group Public Citizen had petitioned the FDA to ban the drug, saying its benefits didn't justify a risk that added up to several hundred deaths a year.
And at a public FDA meeting held in January 2009, a panel of outside experts voted 14-12 that the drug should be pulled from the market.
But the FDA disagreed, and later that year agency officials said they would keep the drug on the market with a bolder warning label about the risk of overdoses.
Based in Newport, Ky., Xenodyne Pharmaceuticals is a privately-held company focused on pain-relieving drugs.
continued at http://www.msnbc.msn.com/id/40274692/ns/health-pain_center/
The Associated Press
WASHINGTON — The maker of the painkiller Darvon is pulling the drug off the market under pressure from public health officials who say it causes potentially deadly heart rhythms.
The Food and Drug Administration said Friday that Xanodyne Pharmaceuticals has agreed to halt marketing of Darvon and the related brand Darvocet, which have been subject to safety concerns for decades.
Three studies by McGill University researchers presented at the annual meeting of the Society for Neuroscience on Sunday show that the way we navigate the world today may indeed affect just how well our brains function as we age.
The FDA has also called on generic drugmakers to stop marketing low-cost drugs containing the active ingredient in Darvon, called propoxyphene.
About 10 million people in the U.S. received prescriptions for Darvon and related drugs in 2009, according to the FDA.
Friday's action puts the U.S. in line with Britain and the European Union, which previously decided to ban Darvon due to suicides and accidental overdoses.
FDA officials said they decided to take action based on a recent study showing Darvon interferes with the electrical activity of the heart, causing irregular heart rhythms that can be fatal.
"With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart," Dr. Gerald Dal Pan, director of FDA's office of surveillance and epidemiology said in a statement.
Dal Pan said patients taking Darvon should continue taking the medication until their doctor prescribes a replacement therapy. Other commonly-prescribed opioid drugs for pain include oxycodone and morphine.
Darvon, which was first approved in the 1950s, is an opioid narcotic used to treat mild to moderate pain. The consumer watchdog group Public Citizen had petitioned the FDA to ban the drug, saying its benefits didn't justify a risk that added up to several hundred deaths a year.
And at a public FDA meeting held in January 2009, a panel of outside experts voted 14-12 that the drug should be pulled from the market.
But the FDA disagreed, and later that year agency officials said they would keep the drug on the market with a bolder warning label about the risk of overdoses.
Based in Newport, Ky., Xenodyne Pharmaceuticals is a privately-held company focused on pain-relieving drugs.
continued at http://www.msnbc.msn.com/id/40274692/ns/health-pain_center/
. I guess since it's not scheduled at all here that that is another incentive to prescribe it instead of some painkiller that actually works. I really havent seen tramadol work for anyone i know no matter how opioid naive they are or how minor the pain is.