Expert Commentary

Abortion pill mifepristone: An explainer and research roundup about its history, safety and future

With abortion-related measures on the ballot in several states, journalistic coverage of the topic has never been more crucial. This piece aims to help inform the narrative on medication abortion with scientific evidence.

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This piece was updated on June 13, 2024 to reflect the recent Supreme Court decision about access to mifepristone, and to highlight new research on medication abortion. It was originally published in November 2023, shortly after the interviews with Ruvani Jayaweera and Carrie Baker took place.

On June 13, the Supreme Court justices in a unanimous decision preserved access to mifepristone, a medication that’s used for the safe termination of early pregnancy, writing that “federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”

The legal future of mifepristone had hung in the balance for several months.

In August 2023, the 5th U.S. Circuit Court of Appeals ruled that mifepristone should not be prescribed past the seventh week of pregnancy, prescribed via telemedicine, or shipped to patients through the mail. In September, the Justice Department asked the Supreme Court to consider a challenge to that ruling.

On Dec. 13, 2023, the Supreme Court justices announced that they would take up the case on the availability of mifepristone. The American College of Obstetricians and Gynecologists issued a statement on the same day urging the court to rule in favor of keeping the pill on the market and available to patients. The justices heard oral arguments on March 26, 2024 before issuing the June 13 ruling.

Meanwhile, abortion is on the ballot in four states this year so far. Measures have also been proposed in several other states, with initiatives that aim to ban, restrict, or expand abortion rights. (State laws that ban abortion apply to both abortion medications and surgical procedures.)

It’s important for journalists covering abortion to have a good understanding of medication abortion so that they can better inform their audiences. Below, we explain what medication abortion is, how individuals access it, and what research shows about its safety and effectiveness.

Medication abortion

Medication abortion is also known as abortion with pills or medical abortion. The Food and Drug Administration has approved medication abortion for up to 10 weeks of pregnancy and the World Health Organization authorizes its use for up to 12 weeks. It is endorsed by several organizations, including the American College of Obstetricians & Gynecologists and the American Medical Association. Medication abortion can also be used beyond 12 weeks of pregnancy, according to several organizations including the World Health Organization and the International Federation of Gynecology and Obstetrics.

Medication abortions accounted for 51% of all abortions in the U.S. in 2020, according to a 2022 CDC report. Use of medication abortion has been on the rise in recent years, increasing by 154% from 2011 to 2020, and by 22% from 2019 to 2020.

In many parts of the world, including the U.S., a two-medication protocol is used for medication abortion: mifepristone followed by misoprostol. Mifepristone blocks the hormone that is required for the continuation of pregnancy, and misoprostol causes the uterus to cramp and expel the pregnancy tissue.

The current approved regimen for medication abortion is 200 mg of mifepristone, followed by 800 mcg of misoprostol within 24 to 48 hours. Individuals are advised to follow up with a health care provider seven to 14 days after taking mifepristone, according to the FDA.

Studies have shown that both drugs are safe and effective. In consultation with medical experts, The New York Times has curated and reviewed a collection of 101 studies on medication abortion, all of which conclude that the pills are safe.

History of mifepristone

Mifepristone, or RU-486, is a drug that blocks progesterone, a hormone that’s needed for a pregnancy to continue.

Developed by the now-defunct French pharmaceutical firm Roussel-Uclaf, the pill was first approved in France and China in 1988. As of May this year, 96 countries have approved it for medication abortion, according to the Guttmacher Institute, a sexual and reproductive health research and policy organization that supports abortion rights.

The FDA approved mifepristone for medical termination of pregnancy in September 2000. Some 5.9 million women in the U.S. used mifepristone between September 2000 and December 2022, 32 of whom died, according to the FDA, which notes in its report that “the fatal cases are included regardless of causal attribution to mifepristone.” Causes of death included infection, homicide, ruptured ectopic pregnancy, drug overdose, and suicide.

Danco Laboratories manufactures Mifeprex, the brand name for mifepristone. In 2019, the FDA approved a generic version of the drug, which is manufactured by GenBioPro. The drug is also manufactured by other companies around the globe.

When the FDA first approved the pill in 2000, the recommended dosage of mifepristone was higher, 600 mg, compared with the current 200 mg. Studies over time showed the lower dose is effective.

Initially, the FDA also required three doctor office visits, on days one, three, and 14 after taking the pill. Prescribers had to be licensed physicians and the drug had to be dispensed in person at a medical facility. The pill was approved to be prescribed within 49 days of gestation, or seven weeks.

By 2016, after evaluating safety data, the FDA modified prescribing requirements, extending the prescription period to up to 70 days of pregnancy, or 10 weeks. It reduced the number of required office visits to one, between seven and 14 days of taking the pill, and the prescriber no longer had to be a physician. Still, mifepristone was not available at brick-and-mortar pharmacies for patients who had a prescription, nor was it available via telemedicine.

But the onset of the COVID-19 pandemic in 2020, which closed many practices and limited in-office doctor visits, changed that.

Mifepristone prescription after COVID-19 and overturn of Roe v. Wade

In December 2021, the FDA reviewed mifepristone’s long-standing safety data and decided to remove the in-person dispensing requirements, expanding access to telehealth visits in states where abortion isn’t banned. The pill can also be mailed to patients since providers no longer have to dispense the pills in person.

It also allowed brick-and-mortar pharmacies that obtain certification from manufacturers to dispense the drug to people in person or through mail with a prescription.

So far, 18 independent brick-and-mortar pharmacies are dispensing mifepristone, and larger drugstore chains may soon join their ranks.

It’s important to note that since approving mifepristone, the FDA has required prescribers to be certified — which means they have to register with the drugmaker. Pharmacies too need to be certified. Advocates say this requirement further limits who can distribute the drug.

In June 2022, the U.S. Supreme Court overturned Roe v. Wade, striking down the constitutional right to abortion and allowing individual states to decide on access to abortion. Since the decision, 14 states have banned abortion altogether. Those bans apply to both surgical and medication abortions.

Misoprostol and misoprostol-only abortions

The second pill used in the two-pill regimen for medication abortion is misoprostol. The pill is approved by the FDA to prevent stomach ulcers in people at high risk of developing them. It was first approved in 1988.

Even though the FDA hasn’t approved it for medication abortion, misoprostol is used off-label as part of the approved two-pill regimen for medication abortion.

Off-label use means health care providers prescribe a drug for diseases or conditions for which it’s not approved by regulatory bodies such as the FDA. They do so when they deem its use is medically appropriate for the patient.

It is also used worldwide for medication abortion, medical management of miscarriage, induction of labor, and treatment of postpartum bleeding. The drug causes the uterus to cramp and expel pregnancy tissue.

The pill can be used alone for medication abortion.

The World Health Organization has endorsed the use of misoprostol-only for ending a pregnancy in parts of the world where mifepristone is not available. Studies have shown the regimen is safe and effective, although it may have more side effects compared with the two-medication regimen.

A study published in JAMA Network Open in October 2023 finds that misoprostol alone is highly effective in self-managed medication abortions.

Abortion with misoprostol alone is rare in the U.S. but the a legal ban on mifepristone could have made it it the only option for some individuals, she says.

“What our study adds is that under the worst-case scenario in which mifepristone is removed, it doesn’t mean that there’s a ban on medication abortion,” says Ruvani Jayaweera, an epidemiologist and research scientist at Ibis Reproductive Health, a nonprofit organization that conducts social science research primarily on access to abortion and contraception around the world. “Our hope is that this study provides assurance to providers and people who are using misoprostol alone, whether it’s in a clinic-based setting or a telehealth setting or a self-managed setting, about the effectiveness of this method.”

Accessing abortion pills

Abortion pills are prescription medications in the U.S. Individuals in states where abortion is still legal can obtain them from licensed providers in person or via telehealth.

Abortion is currently banned in 14 states. Eleven states have laws limiting abortion between six and 22 weeks. Twelve of the 36 states where abortion is available have restrictions on prescribing medication abortion via telehealth, according to the Kaiser Family Foundation.

In response, activists have created networks of support to help individuals access abortion pills, explains Carrie N. Baker, a contributing editor to Ms. Magazine and professor at Smith College who studies and teaches courses on gender, law and public policy.

“The mainstream press is not adequately paying attention to what’s happening in the United States with regard to the underground network of abortion pill access,” says Baker, who has a forthcoming book on the history and politics of abortion pills in the United States.

These networks have also existed to help individuals around the world.

Europe-based Aid Access mails the medication abortion regimen — mifepristone and misoprostol — to all 50 states, regardless of abortion restrictions. There are other U.S.-based services, including Plan C, which provides people with available options to get abortion pills based on the state they live in.

In a November 2022 research letter published in JAMA, Aid Access reported that after the U.S. Supreme Court overturned Roe v. Wade, the average daily requests for telemedicine services for medication abortion increased from 82.6 to 231.7.

In the U.S., prescribing abortion medications via telehealth is nuanced based on state abortion laws.

For instance, U.S.-based virtual reproductive and sexual health clinic Hey Jane and online pharmacies like Honeybee can provide care and ship the pills to people in states where abortion is not banned. In all states, people may obtain medication abortion from alternative telemedicine services, online websites, or community networks, though the legal risk of each of these options may differ depending on the state. Services like ReproLegal Helpline help guide individuals on laws in their state, Jayaweera says.

Also, physicians in states that have passed shield laws can also prescribe medications via telemedicine to people in states where abortion is banned. So far, several states including Washington, Colorado, Massachusetts, Vermont, New York and California have passed telemedicine shield laws for health providers.

Abortion shield laws “seek to protect abortion providers, helpers, and seekers in states where abortion remains legal from legal attacks taken by antiabortion state actors,” according to a review article published in The New England Journal of Medicine in March 2023. Seven states so far have enacted a shield law since the overturn of Roe v. Wade.

But it’s important to know and note that those laws don’t protect individuals, Jayaweera says.

“One of the things to be especially sensitive to is with telemedicine or online models is that even if the risk is very much minimized for the provider, the legal risk falls on the individual in restricted states,” she says, underscoring the importance of educating individuals about those risks during counseling.

Self-managed abortion

Self-managed abortion is when individuals use medication abortion without medical supervision, ordering pills via telehealth, online pharmacies, mail or in-person.

Worldwide, most medication abortions are self-managed, Jayaweera says.

As a reminder, although the drugs are shown to be safe and effective, the individuals who use self-managed abortion may face legal risks, explain Drs. Daniel Grossman and Nisha Verma in a viewpoint published in JAMA in November 2022.

“Resources like the If/When/How legal helpline may be useful for patients and clinicians who are trying to understand their legal risks related to self-managed abortion. Patients requesting emotional support could be connected with resources that provide free confidential talk lines,” the authors write.

Worldwide, 22 countries ban abortion altogether, according to the Center for Reproductive Health, a global advocacy organization, and many others restrict it. This has given rise to safe abortion hotlines and “accompaniment groups” of people who have training in abortion counseling for individuals who are using medication abortion.

They also “provide a lot of empathetic counseling throughout the process and provide people with additional assurance and support and to help them understand if what they are experiencing is normal, or if they need to seek care,’” says Jayaweera.

She was part of a research team that found the outcomes of self-managed abortions were comparable to the ones performed under clinical supervision. The study, among others, contributed to the World Health Organization revising its guidelines last year to add self-managed abortion in early pregnancy to its abortion guidelines.

National organizations including the American Medical Association and the American College of Obstetricians and Gynecologists oppose the criminalization of self-managed abortion because it deters patients from seeking care when complications occur, write Dr. Lisa H. Harris and Daniel Grossman in a review article published in the New England Journal of Medicine in March 2020.

“Given the safety of the combination of mifepristone and misoprostol for self-managed abortion, the biggest danger to patients may be legal prosecution,” the study authors add. “Doctors and health care institutions must develop strategies that favor effective, compassionate clinical care over legal investigation of patients.”

A note on abortion ‘reversal’ pills

On Oct. 30, a judge in Kansas blocked a state law that requires health care providers to tell patients that medication abortion can be reversed, despite a lack of scientific evidence. A few days earlier, in Colorado, a federal judge ruled that a Catholic medical center can’t be stopped from offering medication abortion “reversal” treatment.

So-called abortion medication “reversal” treatment involves taking a dose of the hormone progesterone in an attempt to stop the effects of mifepristone, but it’s important for journalists to inform their audiences that “reversal” of medication abortion is not supported by science. (The Associated Press recommends using quotation marks in order to stress the lack of scientific evidence.) The American College of Obstetricians and Gynecologists has publicly stated that it does not support the treatment.

“Despite this, in states across the country, politicians are advancing legislation to require physicians to recite a script that a medication abortion can be ‘reversed’ with doses of progesterone, to cause confusion and perpetuate stigma, and to steer women to this unproven medical approach,” reads a statement on ACOG’s website. “Unfounded legislative mandates like this one represent dangerous political interference and compromise patient care and safety.”

Between 2012 and 2021, 14 states had enacted abortion “reversal” laws, according to a February article in the American Journal of Public Health.

“States largely use explicit language to describe reversal, require patients receive information during preabortion counseling, require physicians or physicians’ agents to inform patients, instruct patients to contact a health care provider or visit abortion pill reversal resources for more information, and require reversal information be posted on state-managed Web sites,” the authors write. “Reversal laws continue a dangerous precedent of using unsound science to justify laws regulating abortion access, intrude upon the patient‒provider relationship, and may negatively affect the emotional and physical health of patients seeking [a medication abortion].”

A 2020 randomized controlled study of medication abortion reversal, involving 40 patients, ended early because of safety concerns for 12 participants. Some of the women in the study received 400 mg of progesterone after taking mifepristone to “reverse” the abortion. Others were given a placebo after taking mifepristone. Three patients – one had taken progesterone and two had received placebo – had severe hemorrhage and required ambulance transport to the hospital, the authors write.

“We could not estimate the efficacy of progesterone for mifepristone antagonization due to safety concerns when mifepristone is administered without subsequent prostaglandin analogue treatment. Patients in early pregnancy who use only mifepristone may be at high risk of significant hemorrhage,” they write in the study.

A March 2023 systematic review of four studies finds, “based mostly on poor-quality data, it appears the ongoing pregnancy rate in individuals treated with progesterone after mifepristone is not significantly higher compared to that of individuals receiving mifepristone alone.”

A 2015 systematic review of 11 studies on medication abortion reversal during the first trimester of pregnancy finds “evidence is insufficient to determine whether treatment with progesterone after mifepristone results in a higher proportion of continuing pregnancies compared to expectant management.”

Research roundup

The following roundup of systematic reviews examines the safety and effectiveness of medication abortion. They are listed by publication date. The list is followed by additional research and reporting resources.

Effectiveness and Safety of Misoprostol-Only for First-Trimester Medication Abortion: An Updated Systematic Review and Meta-Analysis
Elizabeth G. Raymond, Mark A. Weaver, and Tara Shochet. Contraception, November 2023.

A review of 49 published studies, including a total of 16,354 patients, finds misoprostol-only is effective and safe for the termination of first-trimester pregnancy, especially when mifepristone is not available.

“Technically An Abortion”: Understanding Perceptions and Definitions of Abortion in the United States
Alicia J. VandeVusse, et al. Social Science & Medicine, October 2023.

The study is based on in-depth interviews of 64 cisgender women and 2009 participants in an online survey. Individuals were asked about their understanding of pregnancy outcomes including abortion and miscarriage. “The blurred boundaries between different types of pregnancies and their outcomes emphasize the differences in people’s notions of what constitutes an abortion,” the authors write. “It shapes how abortion stigma can arise across different pregnancy outcomes, as well as people’s own perceptions of the care they have sought, the legality of this care, and their experience in accessing it. Understanding how people construct boundaries around abortion allows for more effective healthcare messaging and advocacy, which is increasingly relevant as legal restrictions on abortion mount while telemedicine and medication abortion become more widely available to some.”

Requests for Self-managed Medication Abortion Provided Using Online Telemedicine in 30 US States Before and After the Dobbs v Jackson Women’s Health Organization Decision
Abigail R. A. Aiken, et al. JAMA, November 2022.

The authors analyze anonymized requests for abortion pills to Aid Access, a Europe-based abortion pill provider. They analyzed the requests before Roe v. Wade was overturned, after the decision was leaked, and after the decision was announced. They find that each of the 30 states from which requests came, regardless of abortion policy, showed a higher request rate after the leak and announcement compared to before. The largest increases were in states that enacted total bans on abortion.

Systematic Review of the Effectiveness, Safety, and Acceptability of Mifepristone and Misoprostol for Medical Abortion in Low- and Middle-Income Countries
Ian Ferguson and Heather Scott. Journal of Obstetrics and Gynaecology Canada. April 2020.

A review of 36 studies, including a total of 25,385 medical abortions, finds the combination of mifepristone and misoprostol is “highly effective, safe, and acceptable to women in low- and middle-income countries, making it a feasible option for reducing maternal morbidity and mortality worldwide.” Among a group of 17,381 women, 0.8% required hospitalization.

Telemedicine for Medical Abortion: A Systematic Review
M. Endler, et al. British Journal of Obstetrics and Gynaecology, March 2019.

A review of 13 studies, mostly based on self-reported data, finds the rates of complete abortion, hospitalization, and blood transfusion after abortion through 10 weeks of pregnancy were at similar levels to those reported after in-person abortion care in the published studies.

First-Trimester Medical Abortion with Mifepristone 200 mg and Misoprostol: A Systematic Review
Elizabeth G. Raymond, Caitlin Shannon, Mark Weaver, and Beverly Winikoff. Contraception, January 2013.

A review of 87 studies, including a total of 47,283 women, finds medical abortion in early pregnancy with 200 mg mifepristone followed by misoprostol is highly effective and safe.

Additional research

Mail-Order Pharmacy Dispensing of Mifepristone for Medication Abortion After In-Person Screening
Daniel Grossman, et al. JAMA Internal Medicine, May 2024.

Pharmacists’ Experiences Dispensing Misoprostol and Readiness to Dispense Mifepristone
Meron Ferketa, et al. Journal of the American Pharmacists Association, October 2023.

Medication Abortion Safety and Effectiveness With Misoprostol Alone
Ruvani Jayaweera, et al. JAMA Network Open, October 2023.

Prior Cesarean Birth and Risk of Uterine Rupture in Second-Trimester Medication Abortions Using Mifepristone and Misoprostol: A Systematic Review and Meta-analysis
Andrea Henkel, et al. Obstetrics & Gynecology, October 2023.

Changes in Induced Medical and Procedural Abortion Rates in a Commercially Insured Population, 2018 to 2022
Catherine S. Hwang, et al. Annals of Internal Medicine, October 2023.

Explaining the Fifth Circuit Court of Appeals Ruling on Mifepristone Access
Molly A. Meegan, JAMA, October 2023.

Effectiveness of Self-Managed Medication Abortion Between 9 and 16 Weeks of Gestation
Heidi Moseson, et al. Obstetrics & Gynecology, August 2023.

Comparison of Mifepristone Plus Misoprostol with Misoprostol Alone for First Trimester Medical Abortion: A Systematic Review and Meta-Analysis
Tariku Shimels, Melsew Getnet, Mensur Shafie, and Lemi Belay. Frontiers in Global Women’s Health, March 2023.

Experiences Seeking, Sourcing, and Using Abortion Pills at Home in the United States Through an Online Telemedicine Service
Melissa Madera, et al. Social Science & Medicine: Qualitative Research in Health. December 2022.

Abortion Surveillance — United States, 2020
Katherine Kortsmith, et al. Morbidity and Mortality Weekly Report, November 2022.

Mifepristone: A Safe Method of Medical Abortion and Self-Medical Abortion in the Post-Roe Era
Elizabeth O. Schmidt, Adi Katz, and Richard A. Stein. American Journal of Therapeutics, October 2022.

Effectiveness of Self-Managed Abortion During the COVID-19 Pandemic: Results From a Pooled Analysis of Two Prospective, Observational Cohort Studies in Nigeria
Ijeoma Egwuatu, et al. PLOS Global Public Health, October 2022.

Increasing Access to Abortion
American College of Obstetricians & Gynecologists, December 2020.

Abortion Pill “Reversal”: Where’s the Evidence
Advancing New Standards In Reproductive Health, July 2020.

A Qualitative Exploration of How the COVID-19 Pandemic Shaped Experiences of Self-Managed Medication Abortion with Accompaniment Group Support in Argentina, Indonesia, Nigeria, and Venezuela
Chiara Bercu, et al. Sexual and Reproductive Health Matters, June 2022.

Medical Abortion in the Late First Trimester: A Systematic Review
Nathalie Kapp, Elisabeth Eckersberger, Antonella Lavelanet, Maria Isabel Rodriguez. Contraception, February 2019.

Continuing Pregnancy After Mifepristone and “Reversal” of First-Trimester Medical Abortion: A Systematic Review
Daniel Grossman, et al. Contraception, September 2015.

Medical Compared With Surgical Abortion for Effective Pregnancy Termination in the First Trimester
Luu Doan Ireland, Mary Gatter, Angela Y. Chen. Obstetrics & Gynecology, July 2015.


What to Know About Fetal Viability — And Why Some Advocates Want It Out of Abortion Law
Mary Chris Jaklevic. Association of Health Care Journalists’ Covering Health blog, October 2023.

#WeCount: A series of reports by the Society of Family Planning aiming to capture the shifts in abortion volume by state and month following the Supreme Court decision to overturn Roe.

History and Politics of Medication Abortion in the United States and the Rise of Telemedicine and Self-Managed Abortion
Carrie N. Baker. Journal of Health Politics, Policy and Law, August 2023.

Mifepristone U.S. Post-Marketing Adverse Events Summary through 12/31/2022
Food and Drug Administration

Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation
Food and Drug Administration

Key Facts on Abortion in the United States
Usha Ranji, Karen Diep and Alina Salganicoff. Kaiser Family Foundation, August 2023.

The Availability and Use of Medication Abortion
Kaiser Family Foundation, June 2023.

A Review of Exceptions in State Abortions Bans: Implications for the Provision of Abortion Services
Kaiser Family Foundation, May 2023.

State Requirements for the Provision of Medication Abortion
Kaiser Family Foundation, April 2023.

Are Abortion Pills Safe? Here’s the Evidence.
Amy Schoenfeld Walker, Jonathan Corum, Malika Khurana, and Ashley Wu. The New York Times, April 2023.

Abortion Care Guideline
World Health Organization, March 2022.

Center for Reproductive Rights provides a global view of abortion.

Abortion Facility Database by Advancing New Standards in Reproductive Health, based at the University of California San Francisco, is a research program that informs the most pressing debates on abortion and reproductive health.

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