FDA Panel Urges Ban of Pain Drug
Experts Recommend Stopping Sale of Darvon, Darvocet
"Every drug you're talking about that's going to deal with pain has difficulty," says Mary Tinetti, MD, a professor of medicine at Yale University. "There is the possibility that the drugs that would take its place would cause at least as much harm in some people."
The FDA considered the issue of propoxyphene after the watchdog group Public Citizen petitioned to have the drug removed. The agency initially did not respond, and the group sued the government to do a review.
Health authorities in the U.K. ordered a phased removal of propoxyphene in 2005. The drug is now almost completely off the market there.
Sidney Wolfe, MD, director, of Public Citizen's Health Research Group, presented data from the Florida medical examiner blaming 85 deaths on propoxyphene in 2007.
"If that's not a risk, I don't know what is," Wolfe tells WebMD.
Darvon and Darvocet are sold by Xanodyne Pharmaceuticals Inc. James B. Jones, MD, the company's vice president for clinical development and medical affairs, tells WebMD that the narrow panel vote offers "plenty of room to have a lot of good discussion" with the FDA over whether the drugs should stay on the market.
If FDA keeps the drug on the market, it could require new safety warnings or other restrictions.
"I'm hoping to do everything we can to keep this product available to the 22 million people who need it," Jones says.
Public Citizen first petitioned to have propoxyphene banned in the 1970s.
"It is at least gratifying to see that a majority of people think this drug should come off the market," Wolfe said after the panel vote.