From Our 2009 Archives

FDA Panel Urges Ban of Pain Drug

Experts Recommend Stopping Sale of Darvon, Darvocet

By Todd Zwillich
WebMD Health News

Reviewed By Louise Chang, MD

Jan. 30, 2009 -- An FDA advisory panel narrowly voted Friday to recommend that a popular pain drug used in dozens of products should be pulled from the market.

The drug, called propoxyphene, has been sold in U.S. pharmacies for more than 50 years and today is used in dozens of generic pain medications. Two brand-name versions of the drug, Darvon and Darvocet, are used by millions of patients each year, according to the FDA.

The panel vote was 14-12 in favor of a recommendation to halt sales of the drugs. The FDA officials say it will take them at least several weeks to decide whether to ban propoxyphene from the market.

"It's not a very clear-cut picture," Sharon Hertz, MD, deputy director of the agency's analgesia drugs division, told reporters. "It's not straightforward that it should or shouldn't come off the market."

But at the same time, monitoring in Florida and nationally by the FDA suggests the drug may play a role in increasing the risk of suicides and accidental deaths. The agency collected reports of more than 1,400 deaths in people who had taken the drug since 1957, though experts stressed the figure does not prove the drug was the cause of death in all cases.

"I would say, little 'b', big 'r' for this drug. That's little benefit and lots of risk. And that's unsettling, says Ruth Day, PhD, a member of the panel from Duke University who voted to remove the drug.

Most other experts said they thought the risk of a drug containing propoxyphene was probably relatively small. But they also worried that there are few studies showing that it is more effective than other drugs that may be safer.

Propoxyphene is a narcotic opioid drug. It "looks like it offers placebo benefits with opioid risks," says Sean Hennessey, PhD, a panel member and epidemiologist from the University of Pennsylvania.

But several experts warned that removing Darvon, Darvocet, and other propoxyphene-containing drugs could cause disruptions for pain patients. They cautioned it could drive patients to other pain medications like OxyContin.

"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.

SOURCES: Sharon Hertz, MD, deputy director, FDA division of anesthesia, analgesia, and rheumatology products. Ruth Day, PhD, Duke University. Sean Hennessey, PhD, University of Pennsylvania. Mary Tinetti, MD, professor of Medicine, Yale University. James B. Jones, MD, vice president for clinical development and medical affairs, Xanodyne Pharmaceuticals Inc. Sidney Wolfe, MD, director, Public Citizen's Health Research Group.

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