The Safety and Effectiveness of Medication Abortion: Research and Public Perspectives

A growing body of research highlights the safety and effectiveness of self-managed medication abortion. Mifepristone, used alongside misoprostol to terminate pregnancies, has been approved as a safe and effective drug by the Food and Drug Administration (FDA) since 2000. Regarding clinical outcomes, the FDA prescribing information notes that 10 clinical trials with collectively more than 30,000 patients found that serious adverse effects occur in fewer than 0.5% of patients. Other studies have found similar rates, and an analysis of more than 100 studies found that, in the vast majority, more than 99% of patients had no serious complications.

Scientific Studies and Self-Managed Abortion

Research continues to explore the nuances of this medical practice. Key reports from scientific studies include:

• Results from the SAFE study published in the Lancet Global Health journal
• Self-managed medication abortion outcomes: results from prospective pilot study
• Misoprostol-alone medication abortion is safe and effective
• Effectiveness of self-managed medication abortion between 13 and 24 weeks gestation

Additionally, Medication abortion regimens studied in the SAFE study provide essential data on what to expect from a self-managed abortion.

Controversies and Methodological Criticism

An April report from the Ethics and Public Policy Center (EPPC), which has been met with criticism over its methodological rigor and lack of data transparency, has led to renewed calls for the FDA to restrict access to mifepristone. The group, which describes itself as working to “push back against the extreme progressive agenda,” analyzed an undisclosed source of insurance claims and reported that almost 11% of patients who took mifepristone experienced a serious adverse event, contradicting the well-established safety profile of the drug.

Although the new report is framed as research-based analysis, the president of the American College of Obstetricians and Gynecologists and other reproductive health specialists say it lacks transparency and overstates risk by relying on broad and undisclosed diagnosis codes, including events not clearly tied to the drug, like ectopic pregnancies. Despite being widely criticized for methodological flaws, lack of transparency, and distortion, findings from the report have been used to amplify false claims that mifepristone is unsafe. Many of the social media posts cited the report’s false claims that “serious complications from abortion pill are 22x higher than FDA reports.”

Public Perception and Polling Data

According to research into public sentiment, a March 2024 KFF Health Tracking Poll found that most of the public oppose banning mifepristone. Overall, two-thirds of U.S. adults say they oppose banning the use of mifepristone, or medication abortion, nationwide with about a third (32%) saying they would support such a ban. In addition, KFF’s May 2023 Health Tracking Poll found that most U.S. adults (55%) say medication abortion pills are either “very safe” (30%) or “somewhat safe” (25%) when taken as directed by a doctor. Partisans remain divided on the question, with majorities of Democrats (72%) and independents (58%) saying medication abortion pills are safe compared to less than half of Republicans (40%).

Summary of Medication Abortion Safety Data