Self-Managed Medication Abortion: Implications for Clinical Practice.

Medication abortion represents more than 50 percent of abortions in the United States (US). Since its approval in the US in 2000, the Food and Drug Administration (FDA) has progressively relaxed the prescribing requirements such that currently, no office visit, in-person dispensing, or ultrasound is required. Obtaining medication for abortion online without medical supervision or evaluation is also possible. This article reviews the complications of medication abortion by examining major studies and delineates the risks specific to self-managed abortion to inform clinicians in caring for women. Summary: Medication abortion has become the most common abortion method in the United States. This document provides a detailed history of the relaxation requirements on medication abortion and reviews the major studies on medication abortion complications including a discussion of their limitations. Finally, the paper delineates the ease of access to medication abortion without a health care provider and the risks associated with self-managed abortion. This paper is intended to provide information for clinicians who likely will be encountering increasing number of patients with such complications.

A Cohort Study of Mental Health Services Utilization Following a First Pregnancy Abortion or Birth.

Objective: To determine whether exposure to a first pregnancy outcome of induced abortion, compared to a live birth, is associated with an increased risk and likelihood of mental health morbidity. Materials and methods: Participants were continuously eligible Medicaid beneficiaries age 16 in 1999, and assigned to either of two cohorts based upon the first pregnancy outcome, abortion (n = 1331) or birth (n = 3517), and followed through to 2015. Outcomes were mental health outpatient visits, inpatient hospital admissions, and hospital days of stay. Exposure periods before and after the first pregnancy outcome, a total of 17 years, were determined for each cohort. Findings: Women with first pregnancy abortions, compared to women with births, had higher risk and likelihood of experiencing all three mental health outcome events in the transition from pre- to post-pregnancy outcome periods: outpatient visits (RR 2.10, CL 2.08-2.12 and OR 3.36, CL 3.29-3.42); hospital inpatient admissions (RR 2.75, CL 2.38-3.18 and OR 5.67, CL 4.39-7.32); hospital inpatient days of stay (RR 7.38, CL 6.83-7.97 and OR 19.64, CL 17.70-21.78). On average, abortion cohort women experienced shorter exposure time before (6.43 versus 7.80 years), and longer exposure time after (10.57 versus 9.20 years) the first pregnancy outcome than birth cohort women. Utilization rates before the first pregnancy outcome, for all three utilization events, were higher for the birth cohort than for the abortion cohort. Conclusion: A first pregnancy abortion, compared to a birth, is associated with significantly higher subsequent mental health services utilization following the first pregnancy outcome. The risk attributable to abortion is notably higher for inpatient than outpatient mental health services. Higher mental health utilization before the first pregnancy outcome for birth cohort women challenges the explanation that pre-existing mental health history explains mental health problems following abortion, rather than the abortion itself.

The Enduring Association of a First Pregnancy Abortion with Subsequent Pregnancy Outcomes: A Longitudinal Cohort Study.

Introduction: Multiple abortions are consistently associated with adverse health consequences. Prior abortion is a known risk factor for another abortion. Objective: To determine the persistence of the association of a first-pregnancy abortion with the likelihood of subsequent pregnancy outcomes. Methods: Data was extracted for a study population of 5453 continuously eligible Medicaid beneficiaries in states which funded and reported elective abortions 1999-2015. Women age 16 in 1999 were organized into three cohorts based upon the first pregnancy outcome: abortion, birth, natural loss. Results: Women in the abortion cohort are more likely than those in the birth cohort to experience another abortion rather than a birth or natural loss, and less likely to experience a live birth rather than an abortion or natural loss, for every subsequent pregnancy. The tendency toward abortion (OR 2.99, CL 2.02-4.43) and away from birth (OR 0.49, CL 0.39-0.63) peaks at the sixth pregnancy, but persists throughout the reproductive period ages 16-32. The pattern is reversed, but similarly consistent, for women in the birth cohort. They remain likelier to have another birth rather than an abortion or natural loss in subsequent pregnancies. Compared to the birth cohort, the abortion cohort had 1.35 times as many pregnancies: 4.31 times the abortions, 1.53 times the natural losses, but only 0.52 times the births. They were 4.3 and 5.0 times as likely to have 2-plus and 3-plus abortions, but only 0.47 times and 0.31 times as likely to have 2-plus and 3-plus births. Of the abortion cohort, 37.1% had no births. By contrast, 73.6% of the birth cohort had no abortions. Conclusion: The first-pregnancy abortion maintains a strong and persistent association with the likelihood of another abortion in subsequent pregnancies, enabling a cascade of adverse events associated with multiple abortions.

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

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.

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.

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.

A second opinion: response to 100 professors.

Induced abortion is a controversial topic among obstetricians. "100 Professors" extolled the benefits of elective abortion in a Clinical Opinion published in AJOG. However, scientific balance requires the consideration of a second opinion from practitioners who care for both patients, and who recognize the humanity of both. Alternative approaches to the management of a problem pregnancy, as well as short and long term risks to women as published in the peer reviewed medical literature are discussed. Maintaining a position of "pro-choice" requires that practitioners also be given a right to exercise Hippocratic principles in accordance with their conscience.