More than one in 10 women may experience serious complications, such as hemorrhaging or severe infection, from medication abortions, according to a large-scale study published Monday.
The new study, published by the anti-abortion Ethics and Public Policy Center, examined insurance claims data from over 865,000 mifepristone prescriptions from 2017 to 2023 and found that nearly 11% of women experience a potentially life-threatening complication within 45 days of a mifepristone abortion.
That’s about 22 times higher than the less than 0.5% complication rate from clinical trials cited by the Food and Drug Administration and Danco Laboratories, the manufacturers of the abortion medication Mifeprex.
In one of the largest real-world studies on mifepristone to date, researchers analyzed insurance codes for nearly 700,000 women across the country over six years, some of whom had multiple medication abortions during the study period.
Researchers identified “serious adverse events” using several different insurance and diagnostic codes reported within 45 days of a patient receiving a mifepristone prescription. They chose the 45-day mark to ensure that the complication was related to an abortion rather than a subsequent pregnancy.
Overall, researchers found nearly 95,000 reports of complications following mifepristone abortions, including more than 11,000 cases of infection and almost 29,000 cases of hemorrhaging.
According to the data, more than 800 women experienced sepsis, a life-threatening infection due to an incomplete expulsion of pregnancy tissue.
Nearly 41,000 women visited the emergency room for abortion-related complications, and almost 5,700 women were hospitalized, according to the report.
Danco Laboratories did not respond to the Washington Examiner’s request for comment on the EPPC’s research.
Mifepristone approval history
Abortion-rights advocates argue that there is sufficient evidence that mifepristone is safe, based on post-market data since the FDA first approved the pill in September 2000.
The medication was initially approved for up to seven weeks of pregnancy. Under the original protocol, patients had to undergo three in-person physician visits to determine the age of the pregnancy and rule out dangerous conditions, such as ectopic pregnancy, before the physician could administer the medication.
In 2016, the FDA increased the gestational age limit to 10 weeks and removed the requirement for physicians to report adverse complications, other than death.
Mifepristone opponents, however, say there is insufficient evidence to support the FDA’s 2021 decision to allow the pill to be prescribed without any in-person screening, since the agency only used data collected since 2016, without non-fatal complication reports, to justify the decision.
The FDA did not respond to the Washington Examiner’s request for comment on the EPPC study.
Other studies on mifepristone complications
The EPPC advances policies at the federal and state levels to restrict access to abortion.
But other recent research on mifepristone indicates that women are at a high risk of experiencing complications that are not life-threatening, such as severe pain, during a medication abortion.
A study published in December from the British National Health Service found that nearly half of women undergoing medication abortion experienced more pain than they were told to expect by their healthcare providers. About four in 10 women ranked their pain as “severe.”
Another study published by the University of Pennsylvania in February found that women undergoing medication abortion are at a significantly higher risk of experiencing severe pain and heavy bleeding than those undergoing surgical abortions.
University of Pennsylvania researchers modeled that medication abortion puts a patient at five times the risk of experiencing severe pain and more than nine times at risk of developing serious bleeding complications compared to surgical abortions.
Medication abortions accounted for nearly two-thirds of all abortions in the United States in 2023. Data from 2024 indicate that medication abortion accounts for the rising level of abortions across the country since the Supreme Court overturned Roe v. Wade in 2022.
Pressure on the FDA
New FDA Commissioner Dr. Marty Makary said last week that he had “no plans to take action” to change mifepristone’s current administration protocols, a point he made multiple times during his Senate confirmation this spring. But, he did indicate that data will be the driving force behind any proposed changes.
“If the data suggests something or tells us that there’s a real signal, we can’t promise we’re not going to act on that data,” Makary said last week at the Semafor World Economy Summit.
HAWLEY CRITICIZES FDA’S MAKARY OVER HAVING ‘NO PLANS’ FOR ABORTION PILLS
Sen. Josh Hawley (R-MO), who has sharply criticized Makary for not restricting the abortion drug more swiftly, called the EPPC report “explosive,” saying its findings show “stunning health risks of chemical abortion drugs.”
“The FDA needs to reinstate in-person dispensing immediately, at a minimum,” Hawley posted on X Monday morning.
