Drug Litigation Newsroom

Public Citizen Petitions FDA to Ban Darvon Products

WASHINGTON, D.C. - Public Citizen today petitioned the U.S. Food and Drug Administration (FDA) to immediately begin to phase out the widely prescribed pain reliever propoxyphene (Darvon, Darvocet and generic versions) from the market because the drug has been associated with more than two thousand accidental deaths, is physically addictive and is no more effective than safer alternatives.

Data from the Federal Drug Abuse Warning Network, which provides autopsy information from medical examiners in the United States, has found that 5.6 percent of all drug related deaths were related to propoxyphene during the past 19 years. In 2004, 23 million prescriptions were filled, making propoxyphene the 12th most commonly prescribed generic drug in the United States.  Four companies, Mylan, Mallinkrodt, Teva and QLT account for more than 91% of U.S. prescriptions.

Propoxyphene has been associated with 2,110 reported accidental deaths in the United States since 1981. A large proportion of the accidental deaths attributed to ropoxyphene each year occur because most of the of the drug is converted into a metabolite that is highly toxic to the heart and lasts longer in the body than the original compound, resulting in cardiac depression. Adverse cardiac events associated with propoxyphene include an interruption of heart transmission of electrical impulses, slowed heartbeats
and a decreased ability of the heart to contract properly.

"The number of deaths involving propoxyphene in the U.S. alone is striking," says the petition, filed by Public Citizen and two Swedish experts on propoxyphene, Drs. Ulf and Birgitta Jonasson.

Last year the British government announced a phased withdrawal of the drug because of the drug's negligible effectiveness and the high risk of overdose and death. "It has not been possible to identify any patient group in whom the risk-benefit [ratio] may be positive," the British government stated.

In addition to heart toxicity, popoxyphene is a drug that has been deemed inappropriate for prescription to the elderly because the central nervous system-related adverse events that have been found to increase the likelihood of falls and fall-related fractures in the elderly. Studies have shown that propoxyphene use is widespread in the nstitutionalized
population, in emergency rooms and in community-dwelling older people, populations, in whom propoxyphene is most dangerous.

"The Food the Drug Administration should immediately begin phasing out the use of propoxyphene," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "Millions of people, many of them elderly, are being put at risk when using this drug when there are safer, more effective alternatives available. We agree with the British government's conclusion that the efficacy of this product 'is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable.'"