Chinese Journal of Pharmacovigilance ›› 2012, Vol. 9 ›› Issue (3): 152-155.

• Orginal Article • Previous Articles     Next Articles

The Characteristic Analysis of Withdrawal of Dextropropoxyphene in the US

LI Shan1, WEI Jing2, XU Yan3, YANG Yue1, *   

  1. 1 School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
    2 Center for Drug Reevaluation of Liaoning, Liaoning Shenyang 110016, China;
    3 Center for ADR monitoring of Guangdong, Guangdong Guangzhou 510080, China
  • Received:2011-11-11 Online:2012-03-10 Published:2015-08-10

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Abstract: Objective To analyze how FDA dealed with the withdrawal of dextropropoxyphene and its characteristics.MethodsAnalyze the background of the withdrawal of dextropropoxyphene, the investigation of adverse events of dextropropoxyphene and the measures taken by FDA by literature study. ResultsThe withdrawal of dextroprop-oxyphene is the direct result of scientific evidence. The risk management of dextropropoxyphene is perfect before its withdrawal. FDA attaches importance to risk communication and provides a stable environment to the withdrawal of dextropropoxyphene. ConclusionStudy and apply the risk management and evidence-based view is priority of our medicine management.

Key words: FDA, dextropropoxyphene, withdrawal