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Deaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019

https://pubmed.ncbi.nlm.nih.gov/33939340/

Kathi Aultman 1, Christina A Cirucci, Donna J Harrison 2, Benjamin D Beran 3, Michael D Lockwood 4, Sigmund Seiler 5
Affiliations expand
PMID: 33939340
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.

The deaths included: 9 (45.00%) sepsis, 4 (20.00%) drug toxicity/overdose, 1 (5.00%) ruptured ectopic pregnancy, 1 (5.00%) hemorrhage, 3 (15.00%) possible homicides, 1 (5.00%) suicide, 1 (5.00%) unknown. (Table 1).

Retained products of conception and hemorrhage caused most morbidity. There were 75 ectopic pregnancies, including 26 ruptured ectopics (includes one death).

There were 2243 surgeries including 2146 (95.68%) D&Cs of which only 853 (39.75%) were performed by abortion providers.

Of 452 patients with ongoing pregnancies, 102 (22.57%) chose to keep their baby, 148 (32.74%) had terminations, 1 (0.22%) miscarried, and 201 (44.47%) had unknown outcomes.

Hemorrhage occurred more often in those who took mifepristone and misoprostol (51.44%) than in those who took mifepristone alone (22.41%).

Conclusions: Significant morbidity and mortality have occurred following the use of mifepristone as an abortifacient. A pre-abortion ultrasound should be required to rule out ectopic pregnancy and confirm gestational age. The FDA AER system is inadequate and significantly underestimates the adverse events from mifepristone.

A mandatory registry of ongoing pregnancies is essential considering the number of ongoing pregnancies especially considering the known teratogenicity of misoprostol.

The decision to prevent the FDA from enforcing REMS during the COVID-19 pandemic needs to be reversed and REMS must be strengthened.

Keywords: Abortifacient; Abortion Pill; Adverse Event Reports; Adverse Events; DIY Abortion; Drug Safety; Emergency Medicine; FAERS; FDA; Medical Abortion; Medical Abortion Complications; Mifeprex; Mifepristone; Misoprostol; No touch abortion; Post-marketing Surveillance; REMS; RU-486; Risk Evaluation Mitigation Strategy; Self-Administered Abortion.

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MeSH terms
Abortifacient Agents* / adverse effects
Abortifacient Agents, Steroidal / adverse effects
Abortion, Induced / adverse effects
COVID-19
Female
Humans
Mifepristone / adverse effects*
Misoprostol
Pandemics
Pregnancy
SARS-CoV-2
Substances
Abortifacient Agents
Abortifacient Agents, Steroidal
Misoprostol
Mifepristone
Related information
MedGen
PubChem Compound (MeSH Keyword)

TTT # 2022-2468
NDA 020687
ANDA 091178

Mifepristone U.S. Post-Marketing Adverse Events Summary through 12/31/2022

The following information is from United States (U.S.) post-marketing reports received by FDA of adverse events that occurred among patients who had taken mifepristone for medical termination of pregnancy

https://www.fda.gov/media/164331/download

(SEE LINK ABOVE FOR DATES RANGES OF ADVERSE EVENTS FOR TABLE 1 AND 2 LISTED BELOW)

Table 1. Cumulative Post-Marketing Fatal and Ectopic Pregnancy Reports in U.S. Women Who Used Mifepristone for Medical Termination of Pregnancy

Date range of cumulative reports 09/28/00† - 12/31/22

Died ‡ 32

*Ectopic pregnancies || 97
† U.S. approval date

Table 2. Post-Marketing Adverse Events in U.S. Women Who Used Mifepristone for Medical Termination of Pregnancy

Date ranges of reports
received

09/28/00† - 10/31/12 and

11/01/12 - 12/31/22‡

Cases with any adverse event 2740 1478

Hospitalized, excluding deaths 768 281

*Experienced blood loss requiring

transfusions § 416 188

Infections || 308 110
*Severe infections 57 18