FDA experts to consider Darvon ban

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 [1]. 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 [2]

Related Article:
FDA sued for failing to act on painkiller [1]
Group demands ban of painkiller Darvocet [3] (Feb 2006)