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FDA experts to consider Darvon ban
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Another set of pain pills faces possible extinction because of abuse: The FDA is asking an advisory committee to weigh in on whether to keep Darvon and Darvocet meds on the market.
Darvon (propoxyphene) was originally developed by Eli Lilly and has been on the market for more than half a century. Darvocet combines Darvon's active ingredient with acetaminophen. Both meds are sold as generics now, and more than 20 million scrips were written for products containing their API in 2007.
So what's the beef? Consumer watchdog Public Citizen petitioned the FDA to get the products banned, then sued when the agency didn't act. The lawsuit cited data implicating propoxyphene in 5.6 percent of the drug related deaths from 1981 to 1999. Plus, Public Citizen claims, the products are "relatively weak" painkillers, and they're toxic at only slightly more than the recommended dosage. U.K. health officials pulled the products in 2006 because of similar concerns, the Wall Street Journal reports.
FDA says it found 1,452 deaths associated with propoxyphene from 1957 through September 2008, but some of those reports listed more than one drug. Two of the generics makers selling the propoxyphene products--Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals--say they're safe and effective when used as directed, and they pointed out that more than 600 million scrips for the drugs have been dispensed over the past 50 years.
- read the WSJ story
Related Article:
FDA sued for failing to act on painkiller
Group demands ban of painkiller Darvocet (Feb 2006)
Comments
By Michael R. Cole | Posted 1:37am | April 25, 2009
I have to oppose this ban. I have had to have several teeth extracted over the years, starting with my wisdom teeth. I have also had my nose fixedd to help with breathing problems.
Vicodin flat does not work in my system and codeine is far too weak for extraction pain. Tramadol plugs up my digestive system because it is too strong. Propoxyphene is just about right in that it takes the edge off of extraction and post operative pain. The principle side effect with propoxyphene is that it acts as an antiaphrodisiac because it dulls lots of nerves.
Later on, alpha immumoglobin production faltered causing both tooth decay and fungal sinusitis. In the fall of 1997 I started allergy shots against a bone eating fungus named Mucor not a month too soon to keep it from drilling through my skull and into my brain. Since I also had inadequate saliva circulation at the time Mucor proceeded to eat my teeth. I eventually had to have all upper teeth pulled and only have 6 lower teeth left.
I have also had congenital arthritis in my legs since I was 3 years old and in my back since I was 13. It would be kind of nice to be able to take propoxyphene once a week as a sleeping pill but with the political prejudice against narcotics that is not likely to happen.
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