Issa Amalia M, Phillips Kathryn A, Van Bebber Stephanie, Nidamarthy Hima G, Lasser Karen E, Haas Jennifer S, Alldredge Brian K, Wachter Robert M, Bates David W
Program in Personalized Medicine and Targeted Therapeutics, University of Houston, 300 Technology Building, Houston, TX 77204-4021, USA.
Curr Drug Saf. 2007 Sep;2(3):177-85. doi: 10.2174/157488607781668855.
There have been a number of highly publicized safety-based drug withdrawals in the United States in recent years. We conducted a review of drugs withdrawn since 1993 and examined trends in drug withdrawals. Our objective was to determine the frequency and characteristics of withdrawn drugs and trends since 1993, and to discuss the implications of the findings. We found that a mean of 1.5 drugs per year have been withdrawn since 1993, and that the number of withdrawals has not increased over time. However, some recent drug withdrawals have impacted large numbers of people. The rate of withdrawals alone is not an adequate measure of the status of drug safety in the US, and there is a serious dearth of data that can be used to examine the impact of drug withdrawals. Although drug withdrawals are an important issue to address, drug safety policies need to be developed within the broader context of drug safety and effectiveness. A comprehensive approach will be needed to address the improvement of drug safety. We propose improvements to the evidence base to increase drug safety and assess how new scientific evidence can be incorporated into drug safety efforts.
近年来，美国有许多基于安全原因而备受关注的药品撤市事件。我们对自1993年以来撤市的药品进行了回顾，并研究了药品撤市的趋势。我们的目的是确定自1993年以来撤市药品的频率和特征以及趋势，并讨论这些发现的意义。我们发现，自1993年以来，平均每年有1.5种药品撤市，且撤市数量并未随时间增加。然而，最近一些药品撤市影响了大量人群。仅撤市率并不能充分衡量美国药品安全状况，而且严重缺乏可用于研究药品撤市影响的数据。尽管药品撤市是一个需要解决的重要问题，但药品安全政策需要在药品安全和有效性的更广泛背景下制定。需要采取综合方法来改善药品安全。我们提议改进证据基础以提高药品安全，并评估如何将新的科学证据纳入药品安全工作中。
