Biotech Values

[DewDiligence]

Pubic Citizen wants Darvon off the market, even though it’s been used
for more than 50 years. An FDA panel considers the matter tomorrow.
Side question: Has there ever been a drug that Public Citizen liked?

http://online.wsj.com/article/SB123326421629330211.html

›FDA Panel to Consider Fate of Darvon, Darvocet

JANUARY 29, 2009, 4:28 P.M. ET
By JENNIFER CORBETT DOOREN

WASHINGTON -- The Food and Drug Administration is asking a panel of medical experts to decide Friday whether it thinks pain pills commonly known as Darvon and Darvocet and used by millions of Americans should remain on the market.

In documents prepared for the meeting, an FDA memo suggested the agency didn't have enough evidence from its own database of adverse-event reports to justify removing the drugs from the marketplace, saying the data were "insufficient" to address the question of whether the products should be removed. The memo said the advisory panel, in making a recommendation about whether the products should be allowed to be marketed in the U.S., needs to focus on whether the drugs are effective at treating pain.

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. 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 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.

The FDA's action was prompted by a petition and then lawsuit from Public Citizen, a public-advocacy organization that 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.

The group said 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."

Public Citizen filed its petition with the FDA in 2006 shortly after U.K. health authorities said they'd pull the products off the market amid similar concerns. Public Citizen first asked the parent agency of FDA, which then was the Department of Health, Education and Welfare, to ban the products in 1978 over safety and effectiveness concerns, but the request was rejected in 1979.

Last year, Public Citizen sued the FDA for failure to act on its 2006 petition. Now the agency is taking the matter to an outside panel of medical experts on Friday for advice.

The agency said a review of its adverse-event reporting data base showed 3,028 serious and nonserious 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.

Two of the companies marketing propoxyphene-containing drugs, Xanodyne Pharmaceuticals Inc. and Qualitest/Vintage Pharmaceuticals, said the products are safe and effective when used as directed. The companies said more than 600 million prescriptions for propoxyphene drugs have been dispensed over the last 50 years.

The companies also said the fact that U.K. health authorities pulled similar products off the market isn't relevant in the U.S., where a higher dose of propoxyphene is used. The companies said the lower doses previously used in the U.K. likely resulted in the conclusion that the drugs weren't effective at treating pain.

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.‹