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Insights: Part Two: Misoprostol-only Medication Abortion

Written by Brandy Bautista

This article was published in April 2024, before the Supreme Court released its ruling in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration on June 13th. In its ruling, the Supreme Court unanimously rejected the challenge to mifepristone access.

While we celebrate this decision, we know this will not be the end of attempts to ban mifepristone across the U.S. As such, it is still important to emphasize that medication abortion with misoprostol only is a safe and effective option.

This is part two of our February 2023 Insights written by Angeline Ti. You can read February 2023’s Insights on our website.


On March 26th, 2024, the Supreme Court heard oral arguments in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. This case directly challenges access to mifepristone across the United States by aiming to roll back changes the FDA made to the mifepristone Risk Evaluation and Mitigation Strategy (REMS) in 2016 and 2021. Encouragingly, throughout the oral arguments, the Justices seemed skeptical that the plaintiffs had standing to bring this case. A decision from the Supreme Court on the future of mifepristone is expected at the end of June 2024. It is important to remember that mifepristone has been available in the U.S. for 24 years, and scientific and medical evidence has repeatedly shown that mifepristone is a highly safe and effective medication.

Uncertainty surrounding mifepristone’s future access in the U.S. has led to more attention toward the misoprostol-only regimen: for people up to 12 weeks gestational age, take three to four doses of 800 mcg of misoprostol every three hours. In fact, in March 2024, How To Use Misoprostol-Only for a Medication Abortion was RHAP’s fourth most-visited resource. Most clinical recommendations only suggest the misoprostol-only regimen if mifepristone is inaccessible or unavailable. However, they still acknowledge that the misoprostol-only regimen is extremely safe and that complications are rare.1-3 Additionally, the Society of Family Planning (SFP) concludes the safety of the misoprostol-only regimen is similar to the combined regimen.¹

Other recent evidence from a prospective cohort study offers further support for the safety and effectiveness of the misoprostol-only regimen. It suggests effectiveness may also align more closely with the combined mifepristone and misoprostol regimen than previously thought.2 The study found that in a self-managed setting following the misoprostol-only regimen from the World Health Organization, 91.6% of participants reported no warning signs for follow-up care, and only 0.9% experienced signs of a potential adverse event.2,4 The effectiveness of the misoprostol-only regimen from this study was estimated to be between 88-100%, which is slightly higher than SFP’s estimate of 80-100%.1-2

Even in settings where mifepristone is available, counseling those seeking care on both regimens can be worthwhile as it allows patients the opportunity to make decisions about their own reproductive health care freely. Mifepristone has fewer nuisance side effects than misoprostol, which can cause fever, chills, cramps, and diarrhea. However, misoprostol is inexpensive and accessible.1-2 One can also begin the medication abortion process immediately with misoprostol (compared to waiting 24-48 hours after taking mifepristone with the combined regimen).2 Those seeking abortion care should be able to decide the route that best works for their needs, resources, and goals. This is especially true now, as abortion bans and restrictions are increasingly being enacted across the U.S. Overall, the misoprostol-only route is a valid option for those seeking a safe, effective, and accessible option that can also be used in a self-managed setting.


RHAP Resources:

How To Use Misoprostol-Only for a Medication Abortion

How To Use Abortion Pills Fact Sheet

Abortion Pills Comparison


Non-RHAP Resources:

Ibis Reproductive Health: Misoprostol-only resource hub

Considerations when counseling patients on misoprostol-only

How Effective Is Misoprostol Alone for Medication Abortion?


Sources:

1. Baum, Sarah, et al. “Science Says Misoprostol Only Is Safe and Effective.” Society of Family Planning, 21 Aug. 2023.

2. Jayaweera R, Egwuatu I, Nmezi S, et al. Medication Abortion Safety and Effectiveness With Misoprostol Alone. JAMA Netw Open. 2023;6(10):e2340042. doi:10.1001/jamanetworkopen.2023.40042

3. Prager S, Chaiten L, Diedrich JT, et al. 2024 Clinical Policy Guidelines for Abortion Care. National Abortion Federation. Published February 2024. Accessed April 16, 2024. https://prochoice.org/providers/quality-standards/

4. Abortion care guideline. Geneva: World Health Organization; 2022. License: CC BY-NC-SA 3.0 IGO


Pharma-free: The Reproductive Health Access Project does not accept funding from pharmaceutical companies. We do not promote specific brands of medication or products. The information in the Insights is unbiased, based on science alone.


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