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Group Wants FDA to Ban Painkiller

Jun 20, 2008 | Parker Waichman LLP

Propoxyphene, the addictive prescription painkiller sold under names that include Darvon and Darvocet is too risky to stay on the market, says Public Citizen, a consumer advocacy group suing the US Food and Drug Administration (FDA).

Pubic Citizen petitioned the FDA two years ago to ban Propoxyphene saying it was not any more effective than other, safer painkillers and pointing to at least 2,110 accidental deaths between 1981 and 1999.  Several hundred more accidental deaths have been linked to Darvon/Darvocet every year since, according to Public Citizen’s Health Research Group in its petition, which is planned for submission to FDA acting Commissioner Dr. Andrew von Eschenbach. Public Citizen first sought to ban Propoxyphene in 1978.

The lawsuit was filed in US District Court in Washington and argued that the FDA was in legal violation by not ruling on its petition within the required six months.  The lawsuit states that Propoxyphen is an addictive narcotic that, even when used properly, can cause slowed heartbeat and other serious cardiac side effects.  This February, Public Citizen’s Health Research Group asked the FDA to ban Darvon and Darvocet, two popular painkillers.  Dr. Sidney Wolfe, the group’s director, said Propoxyphene, the drugs’ main active ingredient, is a relatively weak painkiller that presents an unacceptable toxic risk to millions of patients taking it annually. “This a black-and-white example of a drug where its risks far outweigh its benefits … there’s no excuse for this drug to be around” said Wolfe.

Prescriptions for the drug—which has been sold since 1957—have decreased, but 23 million prescriptions were still written for propoxyphene-containing drugs last year.  Darvocet combines propoxyphene with acetaminophen and is the most popular of these types of painkillers.

An analysis of 26 studies comparing propoxyphene and acetaminophen with just acetaminophen or a placebo found the “narcotic combination offered little benefit over acetaminophen alone” in treating pain.  “Thus, propoxyphene provides minimal if any additional analgesia to acetaminophen alone and is associated with significant adverse effects.  It cannot be recommended for routine use,” Dr. Carolyn Sachs of the University of California, Los Angeles, wrote in her analysis, published in March 2005 in American Family Physician.

Wolfe said a “phase-out,” meant to wean users from the drug would be followed by a ban, similar to a move in 2005 by the United Kingdom over Co-proxamol, Britain’s most frequently used drug.  Co-proxamol was banned over concerns about the high risk of accidental death from slight overdose and its frequent use in suicides.  Co-proxamol, is sold under the brand names Distalgesic, Cosalgesic, and Dolgesic in the UK and under the names Darvocet and Darvon in the US.

The body transforms propoxyphene—or codeine—Into norpropoxyphene, which can build up in the body and is associated with a variety of heart problems, including arrhythmia.  Propoxyphene is among the nation’s most widely abused painkillers, Substance Abuse and Mental Health Services Administration spokeswoman Leah Young said, adding that a 2004 survey found 21 million people had made “non-medical” use of products containing propoxyphene.

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