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US panel to weigh continued sale of propoxyphene

This article was originally published in Scrip

Executive Summary

The USFDA's anaesthetic and life support drugs and drug safety/risk management advisory panels will meet on January 30th to consider whether propoxyphene-containing products (such as Xanodyne's Darvocet, Darvon and generics) should remain on the market. The committees will discuss the safety and efficacy data for all products containing the analgesic ingredient, including combination drugs, and whether regulatory action is appropriate. In 2006 the US consumer group Public Citizen petitioned the FDA to begin a phased withdrawal of propoxyphene-containing medicines owing to safety issues. The drug has a cardiotoxic metabolite and has been associated with more than 2,000 accidental deaths in the US since 1981, the group said. Last year Public Citizen sued the FDA for failing to act on the petition.



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