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Public Citizen Petitions FDA to Ban Darvon

Prescription Painkiller Allegedly Causes Many Fatalities

February 28, 2006
Public Citizen today petitioned the U.S. Food and Drug Administration (FDA) to immediately begin to phase out Darvon products, saying the widely prescribed pain reliever is dangerous and no more effective than safer alternatives.

Public Citizen said that propoxyphene (Darvon, Darvocet and generic versions) has been associated with more than 2,000 accidental deaths and is physically addictive.

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 for propoxyphene were filled, making it the 12th most commonly prescribed generic drug in the United States. Four companies – Mylan, Mallinkrodt, Teva and QLT – account for more than 91 percent of U.S. prescriptions.

Propoxyphene has been associated with 2,110 reported accidental deaths in the United States since 1981.

A large proportion of these deaths occur because most 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. The entire petition can be viewed at www.WorstPills.org.

Last year, the British government announced a phased withdrawal of the drug because of its 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, popoxyphene has been deemed inappropriate for prescription for the elderly because of central nervous system-related adverse events – such as sedation and confusion – 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 institutionalized population, in emergency rooms and in community-dwelling older people, populations in whom propoxyphene is most dangerous.

Public Citizen is calling for the drug to be phased out, rather than banned immediately, because of its addictive quality.

"The Food and 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.'"

Public Citizen has a strong track record of identifying dangerous drugs well before federal regulators take action to ban or put warnings on these drugs.

For example, Public Citizen warned consumers about the dangers of Vioxx, ephedra, Bextra, Rezulin, Baycol, Propulsid and many other drugs years before the drugs were pulled from the market.

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