Since the FDA initially approved the abortion drug mifepristone over 20 years ago, the abortion industry has been working overtime to convince the public that it is safe for women. Danco Laboratories, a mifepristone manufacturer, calls it “the safe and effective abortion pill.”
A host of media outlets have repeated dubious (and sometimes downright false) claims about the safety of mifepristone too, especially after the U.S. Supreme Court overturned Roe v. Wade in 2022. But a new study from the Ethics and Public Policy Center turns the “safe and effective” narrative on its head.
The FDA’s removal of safety standards
In 2000, the FDA approved the drug mifepristone for chemical abortions. Mifepristone is used in tandem with another drug, misoprostol, to complete a chemical abortion. At the time, the FDA only allowed the drugs to be prescribed up to seven weeks’ gestation, required a licensed doctor who could diagnose ectopic pregnancies and accurately determine gestational age to be the one to prescribe the drug, and required the doctor to see a woman at three in-person office visits before, during, and after the chemical abortion to ensure she did not have any life-threatening conditions or serious complications.
In addition, the FDA required doctors who prescribed these drugs to report all serious complications. While all these requirements were basic, commonsense protections, the FDA soon began to weaken and even eliminate some of them.
In 2016, upon request from Danco Laboratories, the FDA increased the gestational age limit from seven to ten weeks, reduced the number of in-person visits from three to one, and no longer required the drugs to be prescribed by a physician. It also eliminated the requirement for prescribers to report all serious, non-fatal complications to the FDA, making it nearly impossible to determine whether these changes increased harm to women.
Then, in 2021, during the COVID-19 pandemic, the FDA further undercut its safety standards by allowing mifepristone to be dispensed by mail, concluding any in-person visits were “no longer necessary.” Now, the FDA no longer requires a prescriber, let alone a doctor, to have any in-person contact with a woman before giving her these dangerous abortion drugs.
Currently, mifepristone includes an FDA-approved drug label touting a study that found “less than 0.5 percent” of women who take the drug experience serious complications. But the Ethics and Public Policy Center study tells a much different story.
Abortion drugs harm women
The EPPC conducted what it called the “largest-ever study of the abortion pill” by reviewing 865,727 prescriptions for mifepristone abortions from 2017 to 2023. It gathered data for the study from a health insurance claim database.
The study found that 10.93 percent of women who took mifepristone experienced serious complications—approximately 22 times more than the findings of the FDA-cited study.
According to the study, 3.31 percent of women suffered hemorrhaging, 1.34 percent suffered serious infections, and 0.1 percent suffered sepsis. Nearly 5 percent of women who used mifepristone for abortion needed ER visits, and 2.84 percent needed surgery to complete the abortion they had started chemically.
The EPPC argued that its study was likely more accurate because it analyzed over 800,000 mifepristone abortions, whereas the FDA-cited study included only 30,966 participants from 10 clinical trials. In addition, the EPPC study is much more recent than those clinical trials, some of which were conducted as long as 42 years ago and included the very safeguards that the FDA recklessly removed.
“This study is the statistical equivalent of a category 5 hurricane hitting the prevailing narrative of the abortion industry,” said EPPC President Ryan T. Anderson. “It reveals, based on real-world data, the shocking number of women who suffer serious medical consequences because of the abortion pill.”
The FDA should take action
While the number of women suffering complications from mifepristone is staggering, the fact that it harms women is not a new revelation. The FDA has been recklessly ignoring the dangers of chemical abortion drugs for decades, and its recent actions have only made things worse.
The FDA admitted when it abandoned in-person doctor requirements that “there may be more frequent ED/urgent care visits related to the use of mifepristone when dispensed by mail.” It has also cited data showing that hospitalizations increased by 300 percent without an in-person doctor visit.
But rather than ensuring women’s health and safety, it has allowed the abortion industry to place profits over people.
As the EPPC study clearly demonstrates, it is far past time for the FDA to restore the safeguards it once had for chemical abortion drugs. This is an important first step toward providing women the protection they deserve.
