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Consumer Watchdog Group, Public Citizen, Petitions FDA to Ban All Darvon Products

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Public Citizen “a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in Congress, the executive branch and the courts” has filed a lengthy formal petition (http://www.citizen.org/publications/release.cfm?ID=7420) with the Food and Drug Administration “pursuant to the Federal Food, Drug and Cosmetic Act 21, U.S.C. Section 355(e)(3), and 21 C.F.R. 10.30 to immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products such as Darvocet (propoxyphene and acetaminophen).”

The petition to ban the popular pain reliever propoxyphene, known as Darvon, Darvocet and other generic versions, stems from the drug having “been linked with more than two thousand accidental deaths” and because it “is physically addictive and has not been shown to be any more effective than safer alternatives.”

The petition states that 5.6% of all drug related deaths during the past 19 years were related to propoxyphene, according to data from the Federal Drug Abuse Warning Network, which provides autopsy information from medical examiners in the US.

Yet despite this alarming rate of deaths caused by Darvocet and Darvon side effects, the drug remains widely prescribed, with 23 million prescriptions filled in 2004, making propoxyphene the 12th most commonly prescribed generic drug in the US.

According to Public Citizen, since 1981, propoxyphene has been associated with 2,110 reported accidental deaths in the US. Many of these deaths occur because most of the drug converts into a metabolite that is highly toxic to the heart and lasts longer in the body than the original compound, resulting in cardiac depression.

Negative heart problems associated with propoxyphene include an interruption of heart transmission of electrical impulses, slowed heartbeats and a disabling 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 Britain announced a phased withdrawal of the drug because of the high risk of overdose and death and the drug’s negligible effectiveness. “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 dangerous if prescribed to the elderly because the adverse events related to the central nervous system can increase the likelihood of falls and fall-related fractures in the elderly.

According to previous studies, propoxyphene prescribed widely in the institutionalized population, in emergency rooms and in community-dwelling older people. These populations are particularly vulnerable to the negative effects of propoxyphene.

“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.’”

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