Mifepristone Adverse Events Identified by Planned Parenthood in 2009 and 2010 Compared to Those in the FDA Adverse Event Reporting System and Those Obtained Through the Freedom of Information Act.

IF 1.5 Q3 HEALTH POLICY & SERVICES
Health Services Research and Managerial Epidemiology Pub Date : 2021-12-21 eCollection Date: 2021-01-01 DOI:10.1177/23333928211068919
Christina A Cirucci, Kathi A Aultman, Donna J Harrison
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引用次数: 1

Abstract

Background: As part of the accelerated approval of mifepristone as an abortifacient in 2000, the Food and Drug Administration (FDA) required prescribers to report all serious adverse events (AEs) to the manufacturer who was required to report them to the FDA. This information is included in the FDA Adverse Event Reporting System (FAERS) and is available to the public online. The actual Adverse Event Reports (AERs) can be obtained through the Freedom of Information Act (FOIA).

Methods: We compared the number of specific AEs and total AERs for mifepristone abortions from January 1, 2009 to December 31, 2010 from 1. Planned Parenthood abortion data published by Cleland et al. 2. FAERS online dashboard, and 3. AERs provided through FOIA and analyzed by Aultman et al.

Results: Cleland identified 1530 Planned Parenthood mifepristone cases with specific AEs for 2009 and 2010. For this period, FAERS online dashboard includes a total (from all providers) of only 664, and the FDA released only 330 AERs through FOIA. Cleland identified 1158 ongoing pregnancies in 2009 and 2010. FAERs dashboard contains only 95, and only 39 were released via FOIA.

Conclusions: There are significant discrepancies in the total number of AERs and specific AEs for 2009 and 2010 mifepristone abortions reported in 1. Cleland's documentation of Planned Parenthood AEs, 2. FAERS dashboard, and 3. AERs provided through FOIA. These discrepancies render the FAERS inadequate to evaluate the safety of mifepristone abortions.

Abstract Image

Abstract Image

2009年和2010年计划生育部门确定的米非司酮不良事件与FDA不良事件报告系统和通过信息自由法获得的不良事件的比较
背景:作为2000年加速批准米非司酮作为流产药物的一部分,美国食品和药物管理局(FDA)要求处方者向制造商报告所有严重不良事件(ae),制造商被要求向FDA报告这些事件。该信息包含在FDA不良事件报告系统(FAERS)中,并可在线向公众提供。实际的不良事件报告(AERs)可以通过信息自由法(FOIA)获得。方法:比较2009年1月1日至2010年12月31日米非司酮流产的特异性ae数和总ae数。Cleland等人公布的计划生育流产数据。2 . FAERS在线仪表盘;结果:Cleland在2009年和2010年确定了1530例计划生育米非司酮患者具有特定的ae。在此期间,FAERS在线仪表板仅包含664份(来自所有供应商),FDA通过《信息自由法》仅发布了330份AERs。克利兰在2009年和2010年发现了1158名正在怀孕的孕妇。FAERs仪表盘只包含95个,其中只有39个通过《信息自由法》发布。结论:文献1中2009年与2010年米非司酮流产的aer总数和特异性ae存在显著差异。克利兰计划生育协会的文件,2。2 . FAERS仪表盘;通过《信息自由法》提供的AERs。这些差异使得FAERS不足以评估米非司酮流产的安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
1.60
自引率
6.20%
发文量
32
审稿时长
12 weeks
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