A new study has exposed "serious adverse events" linked to mifepristone, also known as the "abortion pill."
Mifepristone is a "pregnancy blocker" that is used in combination with another medication, misoprostol, to terminate pregnancies, according to Mayo Clinic.
It is also used to manage early miscarriages, as it helps prepare the body to empty the uterus.
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Research by the Ethics & Public Policy Center in Washington, D.C., has revealed that the rate of serious side effects is 22 times higher than what is indicated on the FDA-approved drug label.
After going through an abortion assisted by mifepristone, nearly 11% of women — more than one in 10 — reported experiencing "infection, hemorrhaging, or another serious or life-threatening adverse event," according to the study summary.
The study used insurance claims data that includes more than 865,000 medication abortions prescribed between 2017 and 2023, resulting in what is described as the largest-ever dataset on chemical abortion.
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"By contrast, the current FDA-approved drug label is based on the results of 10 clinical trials with a total of 30,966 women, less than 0.5 percent of whom reportedly experienced severe adverse reactions," the study states.
"Some of these trials were conducted as long as 42 years ago."
The study authors — Jamie Bryan Hall, EPPC’s director of data analysis, and Ryan T. Anderson, EPPC’s president — called the results a "truly shocking and sad reality."
"We weren't exactly surprised by these findings, as other studies of smaller datasets have found significant safety problems with chemical abortion drugs — particularly after the Obama and Biden administrations removed important FDA safety protections that were required when the chemical abortion drug was first approved," the authors said in a statement sent to Fox News Digital.
"The largest limitation, which we're working to address, is that there is no insurance code for death — and sadly, we know that women die from complications resulting from the abortion pill."
Based on the study, the researchers are calling on the FDA to reinstate the original safety protections that they required when they approved mifepristone, stating that "women deserve the truth."
Christina Francis, M.D., CEO of the American Association of Pro Life OBGYNs, who is based in Ft. Wayne, Indiana, was not involved in the research but commented on the significance of the outcome.
"The findings of this study, which analyzes nearly 900,000 drug-induced abortions, align with what I have seen in my two decades of practice as an OB-GYN, during which I have cared for many women who have been lied to about the safety of abortion drugs and suffered significant complications from them," she told Fox News Digital.
Francis concluded that nearly 71,000 women likely suffered these types of severe complications in 2023, based on numbers from the Guttmacher Institute.
"This should serve as a wake-up call for the FDA that the complication rate is over 20 times higher than what has previously stated — and is a public health crisis that should be investigated immediately," she said.
"Women deserve informed consent about the potentially life-threatening dangers of these drugs."
Professor Jessie Hill, a health law expert at Case Western Reserve University in Cleveland, Ohio, also reviewed the study findings.
She stated that mifepristone has been one of the most-studied medications ever since its approval in the U.S. 25 years ago, claiming it is also "one of the safest."
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Hill pointed out that the EPPC’s study is not peer-reviewed and questioned its "potential bias."
"The study uses insurance claims data, but insurance claims are an imperfect proxy for causal medical outcomes," she told Fox News Digital. "They often lack context — a claim for hemorrhage, for instance, may not even be causally linked to mifepristone itself."
Hill also objected to the comparison of modern claims data to the FDA’s clinical trial data.
"Clinical trials have rigorous standards for defining and reporting adverse events. Claims data are generated for billing purposes, not scientific analysis, and often overcount or misclassify events."
Hill also noted that the legal standard for FDA drug regulation is not "no risk," and that all medications have adverse event rates.
"Overstating risks without weighing benefits distorts the regulatory framework," she said.
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Approximately 63% of all abortions in the U.S. in 2023 were medication abortions, according to the Guttmacher Institute. This was an increase from 53% in 2020.
Fox News Digital reached out to the FDA and to the manufacturer of mifepristone for comment.