美国FDA右丙氧芬撤市决策及特点分析

The Characteristic Analysis of Withdrawal of Dextropropoxyphene in the US

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。

Objective To analyze how FDA dealed with the withdrawal of dextropropoxyphene and its characteristics. Methods Analyze the background of the withdrawal of dextropropoxyphene,the investigation of adverse events of dextropropoxyphene and the measures taken by FDA by literature study.Results The 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.Conclusion Study and apply the risk management and evidence-based view is priority of our medicine management.