PMID- 34993274
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220429
IS  - 2333-3928 (Electronic)
IS  - 2333-3928 (Linking)
VI  - 8
DP  - 2021 Jan-Dec
TI  - 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.
PG  - 23333928211068919
LID - 10.1177/23333928211068919 [doi]
LID - 23333928211068919
AB  - 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.
CI  - (c) The Author(s) 2021.
FAU - Cirucci, Christina A
AU  - Cirucci CA
AUID- ORCID: 0000-0002-4681-6529
AD  - Sewickley, PA.
FAU - Aultman, Kathi A
AU  - Aultman KA
AUID- ORCID: 0000-0002-9235-5049
AD  - Charlotte Lozier Institute.
FAU - Harrison, Donna J
AU  - Harrison DJ
AD  - American Association of Pro-Life Obstetricians and Gynecologists, USA.
LA  - eng
PT  - Journal Article
DEP - 20211221
PL  - United States
TA  - Health Serv Res Manag Epidemiol
JT  - Health services research and managerial epidemiology
JID - 101654536
PMC - PMC8724996
OTO - NOTNLM
OT  - United States food and drug administration
OT  - adverse drug reaction reporting systems
OT  - drug-related side effects and adverse reactions
OT  - induced abortion
OT  - mifepristone
OT  - misoprostol
OT  - postmarketing product surveillance
OT  - steroidal abortifacient agents
COIS- Declaration of Conflicting Interests: The author(s) declared no potential 
      conflicts of interest with respect to the research, authorship, and/or 
      publication of this article.
EDAT- 2022/01/08 06:00
MHDA- 2022/01/08 06:01
PMCR- 2021/12/21
CRDT- 2022/01/07 06:30
PHST- 2021/11/22 00:00 [received]
PHST- 2021/12/03 00:00 [revised]
PHST- 2021/12/03 00:00 [accepted]
PHST- 2022/01/07 06:30 [entrez]
PHST- 2022/01/08 06:00 [pubmed]
PHST- 2022/01/08 06:01 [medline]
PHST- 2021/12/21 00:00 [pmc-release]
AID - 10.1177_23333928211068919 [pii]
AID - 10.1177/23333928211068919 [doi]
PST - epublish
SO  - Health Serv Res Manag Epidemiol. 2021 Dec 21;8:23333928211068919. doi: 
      10.1177/23333928211068919. eCollection 2021 Jan-Dec.