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Fax: 571-312-0544

2776 S. Arlington Mill Dr.
#803
Arlington, VA 22206

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Charlotte Lozier Institute

Phone: 202-223-8073
Fax: 571-312-0544

2776 S. Arlington Mill Dr.
#803
Arlington, VA 22206

Maternal & Public HealthAbortion Drugs Issues in Law & Medicine

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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October 6, 2026 A magnifying glass rests on three wooden blocks that spell out FDA, symbolizing a review of the REMS modification. A Critical Analysis of the FDA’s 2021 Mifepristone REMS Modification Rationale Review October 6, 2026 Ultrasound image showing the side profile of a human baby Inside The Government Decision That Opened Up Abortion Pill Floodgates October 6, 2026 A sign for the FDA featuring the agency’s logo and circular seals in front of a brick government building, where clinical guidance for mifepristone REMS is often determined. Unintended Consequences of the FDA’s 2021-2023 Risk Evaluation and Mitigation Strategy (REMS) Changes to Mifepristone

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