Deaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019
Additional Authors: Benjamin D. Beran M.D.; Michael D. Lockwood D.O; Sigmund Seiler M.D.
ABSTRACT:
Objectives: Primary:
Analyze the Adverse Events (AEs) reported to the Food and Drug Administration (FDA) after use of mifepristone as an abortifacient.
Secondary:
Analyze maternal intent after ongoing pregnancy and investigate hemorrhage after mifepristone alone.
Methods:
Adverse Event Reports (AERs) for mifepristone used as an abortifacient, submitted to the FDA from September 2000 to February 2019, were analyzed using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAEv3).
Results:
The FDA provided 6158 pages of AERs. Duplicates, non US, or AERs previously published (Gary, 2006) were excluded. Of the remaining, there were 3197 unique, US-only AERs of which there were 537 (16.80%) with insufficient information to determine clinical severity, leaving 2660 (83.20%) Codable US AERs (Figure 1). Of these, 20 were Deaths, 529 were Life-threatening, 1957 were Severe, 151 were Moderate, and 3 were Mild.
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