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Fate of Darvon, Davocet to Be Discussed

Jan 30, 2009 | Parker Waichman LLP

The popular painkillers Darvon and Darvocet might be removed form the market.  The U.S. Food and Drug Administration (FDA) has convened an expert medical panel to make a recommendation regarding the fate of the two popular pain pills, reported Dow Jones.  Over 20 million prescriptions for the drugs have been written since 2007, said the FDA.

Eli Lilly & Company’s Darvon, contains the active ingredient propoxyphene and has been on the U.S. market for over 50 years, said Dow Jones.  When Lilly later added propoxyphene with the pain medication acetaminophen, it was sold as Darvocet.  Today, the medications are manufactured and marketing by private, generic drug makers such as Xanodyne Pharmaceuticals Inc. of Newport, Kentucky and Qualitest/Vintage Pharmaceuticals, of Huntsville, Alabama, said Dow Jones.

Approved for mild to moderate pain, the propoxyphene medications have been linked to death in patients—especially when used with alcohol and other drugs—and have also been found to be addictive.  According to FiercePharma, it is because of the potential abuse that the FDA advisory committee has been called in to help determine if the drugs should or should not remain on the market.  The WSJ reported that the FDA said the panel needs to look at the drugs’ pain-killing efficacy.

The Wall Street Journal (WSJ) reported that the move by the FDA followed a petition and subsequent lawsuit filed by the advocacy group, Public Citizen, which included information from the Drug Abuse Warning Network that revealed that propoxyphene was involved in 5.6 percent of all drug-related deaths from 1981 to 1999 as well as 2,110 accidental deaths.  Public Citizen is calling for the ban saying that the medications are “relatively weak” pain medications in which “"toxicity develops at only slightly above the recommended daily dose," reported the WSJ.  The Journal said that an FDA memo—part of the meeting documents—indicates that the FDA has insufficient information in its files to justify the ban.

The Public Citizen petition, which was filed against the FDA two years ago, followed the United Kingdom ban of propoxyphene pain killers over concerns of abuse and fatalities linked to the drugs, said the WSJ, which pointed out that Public Citizen has been asking for the drug ban since 1978 when the FDA was operating under the Department of Health, Education, and Welfare.  When the FDA did not act on the petition in 2006, Public Citizen filed suit against the agency, said the WSJ.

Dow Jones reported that an FDA review of its adverse-event reporting data base confirmed 3,028 serious and non-serious reports linked to propoxyphene from 1957 through September 24, 2008; 2,136 reports were considered serious and1,452 ended in death.  The FDA noted that much of the reports involved suicides, intentional and unintentional drug overdoses, and heart attacks; some reports indicted multiple drugs, said Dow Jones.

The two companies marketing the drugs generically said, according to Dow Jones, that over 600 million prescriptions for propoxyphene drugs have filled in the past five decades.

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