Access to Mifepristone
Frequently Asked Questions
Ongoing legal challenges to the U.S. Food and Drug Administration’s (FDA’s) approval of mifepristone (200 mg) have created confusion nationwide about the status of the drug and access to medication management of abortion and early pregnancy loss. As ACOG members continue providing patient care during this time, we understand that both they and their patients have questions. These FAQs have been developed to address questions as they arise in this evolving legal and political landscape. They are based on evidence-informed practice and expert opinion and are intended to supplement the following ACOG documents: Practice Bulletin No. 225, Medication Abortion Up to 70 Days of Gestation, originally published in October 2020; Practice Bulletin No. 200, Early Pregnancy Loss, originally published in November 2018; Committee Opinion No. 815, Increasing Access to Abortion, originally published in December 2020; and Practice Advisory: Updated Mifepristone REMS Requirements, originally published online in January 2023.
This is a rapidly changing landscape, and FAQs will be added or modified on a regular basis as additional information becomes available.
Frequently Asked Questions
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Last updated April 26, 2023 at 9:35 a.m. EST.
Two conflicting legal challenges to the FDA’s approval of mifepristone (200 mg) for medication abortion and its subsequent regulation of the medication have left the nationwide status of the drug uncertain. In response to one of these lawsuits (Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration), on April 21, 2023, the Supreme Court took action to maintain temporary access to mifepristone in states where medication abortion is permitted by law, and current FDA rules for prescribing and dispensing of mifepristone remain in effect for now. The Supreme Court’s April 21 order is not final and just maintains the status quo for mifepristone access for the time being.
If access to mifepristone is blocked or restricted as the litigation proceeds through the courts, clinicians will need to counsel patients about alternatives to mifepristone for abortion care and management of early pregnancy loss (see If mifepristone is unavailable, what are alternative management options for abortion care and early pregnancy loss?).
The legal activity in these cases is proceeding and changing rapidly. For the most current information on the status of these cases, see ACOG’s Mifepristone in the Courts and ACOG News.
Alliance for Hippocratic Medicine v. U.S. Food and Drug AdministrationThis case, filed in Texas by a group of antiabortion medical organizations and physicians, seeks to overturn the FDA’s approval of mifepristone nationwide, disregarding more than 20 years of data that support mifepristone’s safety and efficacy for the medication management of abortion and early pregnancy loss (ACOG Northern Texas District Court Amicus Brief, PB 225, PB 200, FDA Mifepristone Information, 2016 FDA Mifepristone Medical Review). The plaintiffs are challenging the FDA’s initial approval of mifepristone in 2000 and the agency’s subsequent changes to the medication’s Risk and Mitigation Evaluation Strategy (REMS) (ACOG Updated Mifepristone REMS PA).
If the Texas lawsuit is successful, it will have devastating effects nationwide, even in states where abortion remains legally protected (ACOG Northern Texas District Court Amicus Brief). The ban on mifepristone will deny patients access to the most effective medication regimen for abortion care and management of early pregnancy loss and will impose the greatest harm on those who already face significant barriers to obtaining reproductive health care, including people of color, individuals with low incomes, and those living long distances from a health care professional (ACOG Northern Texas District Court Amicus Brief, Fuentes 2023).
State of Washington et al. v. U.S. Food and Drug Administration et al.
This lawsuit, which was filed by the Attorney General of Washington State and joined by the attorneys general of 16 other states and the District of Columbia, seeks to protect access to mifepristone and medication abortion. The plaintiffs are challenging the FDA’s January 2023 REMS restrictions on the use of mifepristone, arguing that there is no scientific or medical basis for these regulations, and they create a barrier to access of essential health care (KFF Sobel 2023, ACOG Updated Mifepristone REMS PA).
Resources
(These links are for informational purposes only and should not be considered developed or endorsed by the American College of Obstetricians and Gynecologists.)
- KFF: Update on the Status of Medication Abortion and the Courts
- KFF: Legal Challenges to the FDA Approval of Medication Abortion Pills
- KFF Q & A: Implications of Two Conflicting Federal Court Rulings on the Availability of Medication Abortion and the FDA’s Authority to Regulate Drugs
- Society for Maternal-Fetal Medicine. Medication Abortion. Case Timeline and Updates
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Last updated April 26, 2023 at 9:35 a.m. EST.
No. An abundance of evidence clearly indicates that mifepristone is exceedingly safe and effective. Since 2000, mifepristone (200 mg) has been approved by the FDA for use in combination with misoprostol for medication abortion (PB 225, FDA Mifepristone Information, FDA Mifepristone Q&A). Mifepristone in combination with misoprostol also is a recommended, evidence-based treatment for early pregnancy loss (PB 200). The Texas lawsuit to reverse FDA approval of mifepristone (Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration) was filed by a group of antiabortion medical organizations and physicians and is based on ideology not science. It disregards more than 20 years of data that support mifepristone’s safety and efficacy for the medication management of abortion and early pregnancy loss (PB 225, PB 200, FDA Mifepristone Information, 2016 FDA Mifepristone Medical Review). Because of mifepristone’s extensive safety record, the FDA recently removed the in-person dispensing requirement, helping to facilitate patient access to essential reproductive health care and reduce the burden on the health care delivery system (ACOG Updated Mifepristone REMS PA, FDA Mifepristone Information, FDA Mifepristone Q&A).
Mifepristone for Medication Abortion
Medication abortion efficacy rates with the combined regimen (200 mg of mifepristone, 800 micrograms of misoprostol vaginally or buccally) range from approximately 92% to 99% up to 70 days of gestation, with higher rates of efficacy at earlier gestational ages (PB 225). Although mifepristone is FDA approved to be used with misoprostol for medication abortion through 70 days of gestation, evidence and expert guidelines support use with more advanced gestations (Kapp 2018, PB 135, Dzuba 2020, NAF 2022, WHO 2022). Adverse effects can occur after mifepristone administration but are more typically experienced after misoprostol administration. Minor short-term adverse effects associated with misoprostol use include nausea (43–66%), vomiting (23–40%), diarrhea (23–35%), headache (13–40%), dizziness (28–39%), and thermoregulatory effects such as fever, warmth, hot flushes, or chills (32–69%) (PB 225, Creinin 2007, Creinin 2004, Winikoff 2008, Schaff 1999). Serious adverse events with the combined mifepristone–misoprostol regimen are uncommon. In patients who receive mifepristone and vaginal misoprostol, the need for intervention within the first 24 hours of treatment is rare, occurring only in 0.2% of patients (Allen 2001). Overall, less than 1% of patients will obtain an emergency intervention for excessive bleeding (Creinin 2000, Henshaw 1993, Rørbye 2005, Aubény 1995), and the need for blood transfusion is rare (0.1% of patients or less) (Cleland 2013, Grossman 2017).
Mifepristone for Management of Early Pregnancy Loss
In a randomized controlled trial of 300 participants undergoing medication management for early pregnancy loss, those who received mifepristone (200 mg orally) followed by misoprostol (800 micrograms vaginally) 24 hours later had increased rates of complete expulsion (relative risk [RR], 1.25; 95% CI, 1.09–1.43) compared with those who received misoprostol alone (800 micrograms vaginally) (Schreiber 2018, PB 200). The mifepristone–misoprostol regimen also was associated with a decreased risk of surgical intervention with uterine aspiration to complete treatment (RR, 0.37; 95% CI, 0.21–0.68). Reports of bleeding intensity and pain as well as other adverse effects were generally similar for the two treatment groups, and the occurrence of serious adverse events was rare among all participants. These results are consistent with the demonstrated efficacy and safety of the mifepristone–misoprostol combined regimen for medication abortion (PB 225).
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Last updated April 26, 2023 at 9:35 a.m. EST.
When a combined mifepristone–misoprostol regimen is not available or desirable to a patient, alternative management options can be used. Clinicians should reassure patients that misoprostol-only medication management (Raymond 2023) and uterine aspiration are safe and effective alternative options for abortion care and management of early pregnancy loss (PB 225, PB 200). Expectant management is another option that can be discussed with patients with early pregnancy loss who do not have medical complications or symptoms that require urgent uterine evacuation (PB 200). Patient–physician shared decision-making is recommended to help patients decide on a management option and should include discussion of the advantages, disadvantages, and different features of all available methods (PB 225, PB 200, CO 819).
Misoprostol-only regimens for medication abortion have been commonly used for decades worldwide and, based on robust safety and efficacy data, are recommended as safe and effective alternatives to a combined mifepristone–misoprostol regimen by ACOG and many other national and international medical organizations (Raymond 2023, PB 225, NAF 2022, WHO 2022, RCOG 2022). A 2019 systematic review of 38 studies found that of the 5,338 patients who received three or more doses of misoprostol, 87% had complete abortions (Raymond 2019). Across all studies (N=12,829 patients), which used a variety of misoprostol-only regimens, only 0.7% of patients required hospitalization or received a transfusion, suggesting similar rates of major complications as those seen with combined mifepristone–misoprostol regimens (Raymond 2019).
Misoprostol-based regimens also have been extensively studied and used for the management of early pregnancy loss (PB 200, Lemmers 2019). A large U.S. randomized trial (N=652) demonstrated complete expulsion by day 3 in 71% of women with first-trimester pregnancy loss after one dose of 800 micrograms of vaginal misoprostol (Zhang 2005). The success rate was increased to 84% after a second dose of 800 micrograms of vaginal misoprostol was administered if needed.
For more information on alternatives to mifepristone for medication abortion and the management of early pregnancy loss, please see the following ACOG clinical guidance and educational resources:
- Practice Bulletin No. 225, Medication Abortion Up to 70 Days of Gestation
- Practice Bulletin No. 200, Early Pregnancy Loss
- Webinar: Medication Abortion Up to 70 Days Gestation
- Simulation: First-Trimester Uterine Aspiration
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Last updated April 26, 2023 at 9:35 a.m. EST.
ACOG has developed a patient resource that addresses the current threats to mifepristone access and reviews alternative options for abortion care and management of early pregnancy loss: ACOG Expert View: What to Know About Abortion and Miscarriages With or Without Mifepristone.
The following ACOG patient education resources provide more information on abortion care and can help guide counseling and shared decision-making:
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Last updated April 26, 2023 at 9:35 a.m. EST.
Medication abortion (with mifepristone–misoprostol or misoprostol-only regimens) can be provided safely and effectively by telemedicine with a high level of patient satisfaction, and telemedicine improves access to early abortion care, particularly in areas that lack a health care practitioner (PB 225, Hyland 2018, Grossman 2013). Medication abortion through telemedicine has been evaluated in observational studies and found to be equally effective as an in-person visit (Grossman 2017, Grossman 2011, Kohn 2019, Endler 2019). In an analysis of nearly 20,000 medication abortions, adverse events were rare (0.3% overall) and did not differ between those who choose telemedicine or in-person services (Grossman 2017, Kohn 2019). Telemedicine also may help reduce the rate of delays to care because of barriers in access to abortion care in remote areas (Grossman 2013).
Despite this evidence, some states have passed legislation that bans the use of telemedicine to provide medication abortion, including through the use of misoprostol-only regimens (Guttmacher 2023). ACOG encourages clinicians to seek out and obtain guidance specific to their state laws and regulations as well as institutional policies before making any changes to their clinical practice.
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Last updated April 26, 2023 at 9:35 a.m. EST.
It is understandable that states want to make sure that there are supplies available for their residents. However, it is unclear whether states could use this stockpiled medication if the FDA is ordered to take mifepristone off the market. Moreover, stockpiling medications like mifepristone and misoprostol for certain states to use brings to light an equity issue. Patients’ health care should not depend on whether their state stockpiled the medication, and stockpiling could contribute to unnecessary shortages of these medications in other states. Misoprostol has important uses not just in abortion and early pregnancy loss care, but also for labor induction and postpartum hemorrhage. Shortages of this medication in some states would have devastating consequences for patients.
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Last updated April 26, 2023 at 9:35 a.m. EST.
Members with specific legal questions about mifepristone or abortion should consult their institution’s lawyers and can also reach out to the Abortion Defense Network, a program that connects people who have legal questions related to abortion care with attorneys who provide legal advice and representation in civil and criminal proceedings. ACOG continues to monitor this rapidly evolving situation. We will continue to update our members in response to any additional changes regarding mifepristone.
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Last updated April 26, 2023 at 9:35 a.m. EST.
ACOG remains undeterred in its advocacy efforts to keep mifepristone available for the provision of safe, effective, evidence-based reproductive health care. Most recently, ACOG and the Society for Maternal-Fetal Medicine called on the U.S. Supreme Court to reverse the lower court’s decision in its entirety. ACOG also led a coalition of medical societies in submitting amicus briefs to the Supreme Court, the Fifth Circuit Court of Appeals, and the Northern Texas District Court. We will continue to make clear to the courts that mifepristone is safe, effective, critical health care. And ACOG will continue to update our members in response to any additional changes regarding mifepristone.
See the following resources for more information about ACOG’s work to support access to reproductive health care:
The American College of Obstetricians and Gynecologists recognizes and supports the gender diversity of all patients who seek obstetric and gynecologic care. In original portions of this document, authors seek to use gender-inclusive language or gender-neutral language. When describing research findings, this document uses gender terminology reported by investigators. To review ACOG’s policy on inclusive language, see https://www.acog.org/clinical-information/policy-and-position-statements/statements-of-policy/2022/inclusive-language.
This information is designed as an educational resource to aid clinicians in providing obstetric and gynecologic care, and use of this information is voluntary. It does not constitute legal advice; clinicians should be familiar with and comply with federal, state, and local restrictions on abortion, including medication abortion, and are encouraged to consult with a lawyer when navigating local abortion laws and regulations. This information should not be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. It is not intended to substitute for the independent professional judgment of the treating clinician. Variations in practice may be warranted when, in the reasonable judgment of the treating clinician, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology. The American College of Obstetricians and Gynecologists reviews its publications regularly; however, its publications may not reflect the most recent evidence. Any updates to this document can be found on acog.org/clinical.
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The American College of Obstetricians and Gynecologists (ACOG) is the nation’s leading group of physicians providing evidence-based obstetric and gynecologic care. As a private, voluntary, nonprofit membership organization of more than 60,000 members, ACOG strongly advocates for equitable, exceptional, and respectful care for all women and people in need of obstetric and gynecologic care; maintains the highest standards of clinical practice and continuing education of its members; promotes patient education; and increases awareness among its members and the public of the changing issues facing patients and their families and communities. acog.org