中国药物警戒 ›› 2012, Vol. 9 ›› Issue (3): 152-155.

• 管理及工作研究 • 上一篇    下一篇

美国FDA右丙氧芬撤市决策及特点分析

李姗1，魏晶2，许燕3，杨悦1，*   

  1. 1 沈阳药科大学工商管理学院，辽宁 沈阳110016；
    2 辽宁省食品药品监督管理局技术审评中心，辽宁 沈阳110016；
    3 广东省药品不良反应监测中心，广东 广州 510080
  • 收稿日期:2011-11-11 出版日期:2012-03-10 发布日期:2015-08-10
  • 通讯作者: 杨悦,女,副教授,博士研究生导师,药品政策、法规。E-mail：yyue315@126.com
  • 作者简介:李姗，女，在读硕士研究生，药事管理。

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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摘要： 目的分析FDA对右丙氧芬撤市事件的处理过程及特点。方法运用文献研究方法，通过查阅国外文献，从右丙氧芬撤市的背景、FDA对右丙氧芬不良反应的调查及所采取的措施等方面进行研究。结果FDA右丙氧芬撤市决定是基于实证的直接结果，FDA在右丙氧芬撤市之前进行了完善的风险管理，FDA重视风险沟通，为撤市提供了稳定的环境基础。结论学习和运用风险管理和循证理念是我国药品监管的当务之急。

关键词: FDA, 右丙氧芬, 撤市

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