Group calls for propoxyphene phase-out

March 6, 2006

A citizen's petition has been filed with the FDA calling for a phased withdrawal of propoxyphene-containing drugs due to their toxic side effects. The group responsible for the move, Public Citizen, said that the risks associated with the painkiller—including the conversion of the drug to a toxic metabolite that leads to cardiac depression—far outweigh the benefit.

Group calls for propoxyphene phase-out

A citizen's petition has been filed with the FDA calling for a phased withdrawal of propoxyphene-containing drugs due to their toxic side effects. The group responsible for the move, Public Citizen, said that the risks associated with the painkiller-including the conversion of the drug to a toxic metabolite that leads to cardiac depression-far outweigh the benefit. On the market since 1957, propoxyphene was associated with 2,110 deaths between 1981 and 1999 and provides minimal additional analgesia beyond acetaminophen alone, said the group. The petition argues that the drug is physically addictive and is no more effective than safer alternatives. The United Kingdom announced a phase-out plan for the drug for similar reasons in January 2005.

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