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Pain drugs with safety questions will get advisory committee review

Executive Summary

FDA will hold a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Jan. 30 to weigh the available safety and efficacy data for all propoxyphene-containing products (including hydrochloric acid, napsylate salts and combination drugs) and decide whether any regulatory action is appropriate. In June 2008, Public Citizen Litigation Group sued FDA for failing to withdraw products containing the painkiller propoxyphene, including AAIPharma's Darvocet (1"The Pink Sheet," July 7, 2008, p. 26)
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