FDA Panel Narrowly Recommends Darvon Be Pulled Off Market
January 30 2009 - 05:43PM
Dow Jones News
A Food and Drug Administration panel of medical experts narrowly
recommended Friday pain pills commonly known as Darvon and Darvocet
should be pulled off the market over concerns the drugs don't work
very well and carry safety risks.
The panel narrowly said, in a 14 to 12 vote, the benefits of the
decades-old drugs didn't outweigh the risks and they should be
removed from the U.S. market. However, the FDA will make the final
decision, and given the essentially split vote it's not clear the
FDA will take the products off the market.
Sharon Hertz, the deputy director of FDA's anesthesia, analgesia
and rheumatology products division, said the agency would also look
at whether it could order post-market studies or change the drugs'
labels.
The advisory panel meeting was prompted by a petition and then
lawsuit from Public Citizen, a public-advocacy organization, that
has asked the agency to remove the products from the market because
there's little evidence the drugs are effective and they carry
risks of death from heart problems.
Darvon, which contains the active ingredient propoxyphene, has
been on the U.S. market for more than 50 years and was developed by
Eli Lilly & Co. (LLY). Later, the company combined propoxyphene
with another pain ingredient, acetaminophen, and sold the pill as
Darvocet.
Both drugs are now marketed by private, generic-drug makers
including Xanodyne Pharmaceuticals Inc. of Newport, Ky., and
Qualitest/Vintage Pharmaceuticals, of Huntsville, Ala. More than 20
million prescriptions were written for the products containing
propoxyphene in 2007, according to the FDA. The companies said the
products were safe and effective when used as directed.
James B. Jones, Xanodyne's vice president for medical affairs
said the company would discuss the panel meeting with the FDA "and
come up with a plan on how to move forward."
The products are approved to treat mild to moderate pain. But
like certain other classes of pain medications, propoxyphene
products can be addictive and have been linked to deaths in
patients, especially when used with alcohol and other drugs, and
the drug labels' currently warn of those risks.
In its petition, Public Citizen cited data from the Drug Abuse
Warning Network, which uses a sample of nationwide autopsy
information from medical examiners - implicating propoxyphene in
5.6% of drug-related deaths from 1981 to 1999. Public Citizen also
said the network reported 2,110 accidental deaths related to
propoxyphene over the same period.
In a presentation before the advisory panel Friday, Dr. Sidney
Wolfe, director Public Citizen's health research group, presented
updated data from the drug-abuse network, which showed 503 deaths
in which propoxyphene was listed as a contributing factor in
2007.
"All drugs have risks," Wolfe said. "If they don't have benefits
they need to come off the market."
In a presentation to the panel, the FDA said some of the
original studies of the drugs showed they had "weak" effects. In
documents prepared for the panel meeting, however, the FDA
questioned whether they had enough evidence of safety problems to
warrant removal of the products.
In 2005, U.K. health authorities said the benefits of the drugs
didn't outweigh the risks and announced a phased withdrawal of the
products over a three-year period, and in 2006 Public Citizen filed
a petition with FDA to remove the products.
Last year, Public Citizen sued the FDA for failure to act on its
2006 petition, which prompted Friday's advisory panel meeting.
The petition said the products should be removed from the market
because they are "relatively weak" painkillers and said "toxicity
develops at only slightly above the recommended daily dose."
The FDA said a review of its adverse-event reporting data base
showed 3,028 serious and non-serious reports from 1957 through
Sept. 24, 2008, associated with propoxyphene. Of those, 2,136
reports were considered serious and included 1,452 deaths. Many of
the serious-event reports included reports of suicides, intentional
drug overdoses, heart attacks and unintentional drug overdoses, the
FDA said. The agency said some of the serious adverse-event reports
also listed more than one type of drug.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
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