In 2023, medication abortions comprised 63% of all abortions nationwide, according to the Институт Гутмахера. Despite its widespread use, and despite assurances that the drug is “as safe as Tylenol,” the abortion pill is not without risk of complications. In fact, a new исследование from the Ethics and Public Policy Center (EPPC) suggests that the rate of serious complications after taking the abortion pill mifepristone (brand name Mifeprex) may be twenty-two times higher than is currently reflected on the FDA drug label.
What is the abortion pill?
The abortion pill refers to the medication mifepristone, which works by antagonizing the effects of the pregnancy-sustaining hormone progesterone. Without proper progesterone levels, a pregnancy cannot continue. Mifepristone is given orally to end a pregnancy up to 10 weeks gestation, and usually the medication misoprostol is then ingested 24-48 hours later to cause uterine contractions to expel the fetal remains.
Mifepristone is manufactured by Danco Laboratories and was originally approved by the FDA in 2000 with multiple safety restrictions in place. Those restrictions were significantly relaxed under the Obama administration in 2016 and again by the Biden administration in 2023. Abortion advocates have celebrated the loosening of regulations, consistently emphasizing that medication abortion is “safe and effective.”
New study tracked abortion pill complications in 692,873 women
A 2025 исследование examining the rate of serious complications from mifepristone was conducted by researchers for the Ethics and Public Policy Center (EPPC), a Washington, DC-based think tank and advocacy organization. EPPC’s President, Ryan T. Anderson, and Director of Data Analysis, Jamie Hall, co-authored the report. According to the study report, “[EPPC’s] real-world post-market observational study of mifepristone is, to our knowledge, the most comprehensive study of chemical abortion safety ever conducted in the U.S.”
Methodology
The EPPC team purchased access to de-identified data from an all-payer health insurance claims database. The study included data from 692,873 women undergoing 865,727 mifepristone abortions between the years 2017 and 2023. (Notably, the population dataset used by the EPPC is 28 times larger than the number of participants included in now decades-old clinical trials cited by the FDA on the mifepristone product label.)
The EPPC researchers analyzed serious complications that took place up to 45 days (that is, 6 weeks and 3 days) after ingesting the abortion pill(s). (They also noted that the decision to use 45 days post-ingestion was a conservative choice, given that some FDA-cited trials studied complications up to 72 days later.) Of the 692,873 women studied, 566,446 women had one medication abortion and 126,427 women had more than one medication abortion.
What abortion pill complications were studied?
Studied complications included: hemorrhage, sepsis, need for blood transfusion, abortion-related ER visit, abortion-related hospitalization, ectopic pregnancy, surgical abortion (to complete a failed medication abortion), other life-threatening adverse events (cardiac, surgery, pulmonary, blood clot, or anaphylactic reactions), and other abortion-related complications (complications with an abortion or miscarriage-specific diagnosis code, plus life-threatening mental health diagnoses).
How did researchers know that the complications were due to the abortion pill and not something else?
The researchers filtered data to identify medication abortions through three different means. Specifically, they searched for “1) procedure code S0199: medically induced abortion by oral ingestion of medication including all associated services and supplies, 2) a prescription for mifepristone (with or without misoprostol within the next 3 days), or 3) a diagnosis code for elective termination or unwanted pregnancy, along with other billing coding consistent with manufacturer instructions for reimbursement for a mifepristone abortion for a given state and insurer combination.”
Why were complication rates so much higher in the EPPC study compared to complication rates from clinical trials?
Remarkably, the complication rate of 10.93% (adjusted to represent the fact that some women experience more than one serious complication) represents a 22-fold increase over the <0.5% rate reported by the clinical trials submitted as part of the original application for the 2000 FDA approval.
According to bioethicist and psychiatrist Dr. Aaron Kheriaty, MD (also an EPPC fellow) in his Substack commentary on the EPPC study, “Real world data can sometimes differ from the findings of highly controlled and selective clinical trials, for example, if the patient selection criteria in clinical practice is less stringent than the controlled experimental conditions of a clinical trial.”
What were abortion pill restrictions like before and what are they like now?
Сайт Этикетка FDA for mifepristone (first approved in 2000 and last revised in 2004) reads: “Adverse events, such as hospitalization, blood transfusion, ongoing pregnancy, or other major complications following the use of Mifeprex and misoprostol must be reported to Danco Laboratories.” Since the 2016 changes made under the Obama Administration, mandatory reporting only applies to deaths attributable to the abortion pill regimen.
Notably, the abortion pill regimen was only originally FDA approved through seven weeks gestation, however, the gestational age limit was increased to 10 weeks in 2016. Importantly, these changes were made without research-based updates to the FDA label to justify this change.
Until 2023, abortion pills had to be dispensed in-office after a consultation with a healthcare clinician (the original 2000 FDA label calls for physician prescription only). Now, abortion pills are available via telemedicine after a single virtual ‘visit’ with a nurse practitioner (or other mid-level healthcare professional) or pharmacist, and the prescription does not require any in-office follow up (again, contrary to the requirements listed on the FDA label).
Some sources call the EPPC study ‘flawed,’ say findings are “overstated”
In the wake of the EPPC study’s debut, AFP USA (the American branch of a French fact-checking agency) wrote an article critiquing the study, which quoted multiple sources, including the president of the American College of Obstetricians and Gynecologists (ACOG), Stella Dantas, reiterating the abortion pill regimen’s safety and efficacy, and calling the study’s methodology and results into question.
Inclusion of ectopic pregnancies
Dr. Jennifer Lincoln, an OB/GYN from Oregon, took particular issue with the study’s listing of ectopic pregnancies as an abortion pill complication, telling AFP USA, “Pills can’t move a pregnancy out of your uterus and into your fallopian tubes.”
Lincoln’s statement is, of course, correct. In the EPPC study’s FAQ document, however, the authors note:
“We do not claim or suggest that mifepristone causes ectopic pregnancies. The warning on the first page of the FDA-approved drug label requires that ectopic pregnancy be ruled out as a condition prior to using mifepristone, precisely because the use of mifepristone by a woman with an ectopic pregnancy poses extraordinary, heightened risk to her health. As noted on page 5 of our report, only events occurring within 45 days following the abortion are included. The study reports 3,062 cases of ectopic pregnancy. These are cases in which a woman was diagnosed with this condition only after she had already taken mifepristone. This failure to properly diagnose the ectopic pregnancy before the abortion attempt placed each of these women’s life [sic] at risk.”
Lack of peer-review
The AFP USA critique also noted that the EPPC study is not peer-reviewed. The EPPC justified their decision to forego the peer-review process, stating in their FAQ:
“We stand behind our analysis of healthcare claims data which is why we are asking the FDA to conduct its own review of this data. Real world data in which money changed hands based on the treatment of patients and coding by doctors brings a higher level of confidence. The dataset is available for purchase and our methodology is public. This study is fully replicable, and we encourage others to replicate it.”
Confounding miscarriage care
Another point of contention raised by ACOG President Stella Dantas (and as quoted in the AFP USA critique) is the potential inclusion of miscarriage care in the EPPC’s data set: “ACOG’s Dantas said the methodology could be overestimating the number of people seeking abortion care by including patients who were prescribed mifepristone to deal with complications associated with miscarriages.”
To this critique, the EPPC’s FAQ replies: “We were very careful to exclude miscarriage care in our report by requiring any mifepristone only prescription was accompanied by a Z332 code (encounter for elective termination of pregnancy) or Z640 (problems related to unwanted pregnancy).”
Lack of patient compliance with two-part regimen
A final critique of the study was its inclusion of mifepristone use without confirmed follow-up with the second part of the abortion pill regimen: misoprostol. According to AFP USA: “Lincoln pointed to flaws with this strategy, including that it counted ‘people who got mifepristone and may have taken that alone, without misoprostol — which is not the evidence-based regimen.'”
However, potential lack of patient compliance with the two-part regimen was likely one of the reasons behind the original Clinton Administration-era approval requirements that abortion drugs only be ingested in a clinical office setting, over three separate in-person visits. “During the Obama and Biden administrations,” the EPPC study reads, “the FDA chipped away at these initial safeguards, risking women’s health in order to increase access to abortion.” The EPPC report therefore recommends reinstating these original safety requirements, also known as Risk Evaluation and Mitigation Strategies (REMS).
What are the next steps for reducing abortion pill complications?
After reviewing the EPPC report, other individuals and organizations are likewise calling for the reinstatement of the FDA’s original REMS for the prescription of mifepristone.
At a minimum, study authors called for robust safety precautions to be added back to the abortion pill prescribing and procurement process. Among them, abortion pill prescriptions should take place in-office (no more telemedicine prescriptions or mail-order abortion pills), after an in-person consultation with a physician and an ultrasound to both date the pregnancy (to confirm the fetus is less than 10 weeks gestation) and to confirm that the pregnancy is intrauterine (i.e., not ectopic, a life-threatening medical emergency for which the abortion pill regimen is contraindicated).
Furthermore, while healthcare professionals as well as abortion pill manufacturer Danco Laboratories are только required to report pill-caused deaths to the FDA, the study authors insisted that все serious adverse events be reported so that abortion-minded women can be given fully informed consent.
The EPPC authors concluded: “The abortion industry tells women that the abortion pill is as safe as Tylenol. That is fundamentally false, and women deserve the truth. Because most women are denied the truth about the abortion drugs, they are terribly unprepared for subsequent complications.”
