FDA Panel Urges Ban of Pain Drug
Experts Recommend Stopping Sale of Darvon, Darvocet
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
"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
"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.