从美国药品撤市看药品安全风险管理

中国药物警戒 ›› 2011, Vol. 8 ›› Issue (4): 212-215.

从美国药品撤市看药品安全风险管理

郭晓昕¹, 杜晓曦¹, 薛松林²

1. 国家食品药品监督管理局药品评价中心,北京 100045;
2. 武田制药有限公司,美国芝加哥 60015

收稿日期:2015-08-27 修回日期:2015-08-27 出版日期:2011-04-10 发布日期:2015-08-27
作者简介:郭晓昕,女,主任药师,药品上市后再评价。

Reviewing Drug Safety Risk Management Based on Drug Withdrawl Experiences in USA.

GUO Xiao-xin¹, DU Xiao-xi¹, XUE Song-lin²

1. Center for Drug Reevaluation, SFDA, Beijing 100045, China;
2. Takeda Pharmaceuticals International, Inc, Chicago, 60015, USA

Received:2015-08-27 Revised:2015-08-27 Online:2011-04-10 Published:2015-08-27

摘要/Abstract

摘要： 目的分析美国上市药品的撤市原因,明确上市药品风险管理对保证公众健康的重要意义。方法通过检索文献和美国FDA网站,收集和分析美国药品撤市信息。结果 1964~2009年期间美国实际撤市的产品为72个,撤市的主要安全性问题为：心血管毒性、致癌风险、肝毒性、血液毒性、皮肤损害、中枢神经系统损害、肾毒性等。结论风险管理应贯穿于药品研发到使用的全过程,而上市后的风险管理尤为重要,药品撤市是上市后安全风险管理的终极手段。

关键词: 上市后药品, 药品安全, 风险管理, 撤市, 美国食品药品监督管理局

Abstract: Objective To analyze causes of drug withdrawls in USA and to emphasize that risk management of post-marketing drugs is very important to the public health. Methodse Medical literatures and US FDA website were searched and analyzed regarding information on drugs that have been withdrawn or removed from the market in USA. Results A total of 72 products were withdrawn or removed from USA during 1964 and 2009. The common safety causes of withdrawal include cardiovascular events, carcinogenic risk, liver toxicity, blood disorders, skin disorders, neurologic/mental disorders, renal toxicity, and so on. Conclusion Risk management should be considered throughout a drug’s lifecycle from development to post-market usage. Risk management of post-marketing drugs is particularly important. Drug withdrawal is the last approach for post-marketing safety risk management.

Key words: post-marketing drug, drug safety, risk management, withdrawal, FDA

中图分类号:

R954

郭晓昕, 杜晓曦, 薛松林. 从美国药品撤市看药品安全风险管理[J]. 中国药物警戒, 2011, 8(4): 212-215.

GUO Xiao-xin, DU Xiao-xi, XUE Song-lin. Reviewing Drug Safety Risk Management Based on Drug Withdrawl Experiences in USA.[J]. Chinese Journal of Pharmacovigilance, 2011, 8(4): 212-215.

参考文献

[1] Janice K.bush, Wanju S.Dai, Gretchen S. Dieck, et al. The Art and Science of Risk Management[J]. Drug Safety,2006, 28 (1):1-18.
[2] ICH Guideline for industry: E1A. The extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening conditions[EB/OL]. [2006-11-23].http://www.fda.gov/cdr/guidance/ichela.pdf.
[3] FDA List of Drug Products that Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness[EB/OL].[ 2010-12-09].http://www.fda.gov/ohrms/dockets/98fr100898b.txt.
[4] FDA Drugs for Human Use Containing Bithionol[EB/OL].[2010-12-08].http://www.fda.gov/ohrmsdockets/ac/98/briefingbook/1998-3454B1_03_WL05.pdf.
[5] FDA Drug Products Containing Adrenal Cortex Extract or Adrenal Cortex Injection l[EB/OL].[2010-12-08].http://www.fda.gov/ohrms/dockets/ac/98/briefingbook/1998-3454B1_03_WL02.pdf.
[6] FDA Phenformin Hydrochloride; Withdrawal of Approval of New Drug Application; Final Decision[EB/OL].[2010-10-29].http://www.fda.gov/ohrms/dockets/ac/98/briefingbook/1998-3454B1_03_WL38.pdf.
[7] FDA HSS News[EB/OL].[2010-12-08].http://www.fda.gov/ohrms/dockets/ac/98/briefingbook/1998-3454B1_03_WL04.pdf.]
[8] FDA FDA Announces. Withdrawal of Fenfluramaine and Dexfenfluramine[EB/OL]. [2010-12-03].http://www.fda.gov/ohrms/dockets/ac/98/briefingbook/1998-3454B1_03_WL22.pdf.
[9] FDA Azaribine Tablets Withdrawal of Approval of New Drug Application[EB/OL].[2010-12-08].http://www.fda.gov/ohrms/dockets/ac/98/briefingbook/1998-3454B1_03_WL03.pdf.
[10] FDA Wyeth-Ayerst Laboratories Announces the Withdrawal of Druact from the market[EB/OL].[2010-12-09].http://www.fda.gov/ohrms/dockets/ac/98/briefingbook/1998-3454B1_03_WL06.pdf.
（因版面有限,部分参考文献省略,如有需要,请联系编辑部）

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