(Oregon Right to Life) — Recently published research has provided striking new data on the risks of the abortion pill mifepristone, finding a severe complication rate more than twenty times the one listed on the drug’s official label.
On Monday, the Ethics and Public Policy Center (EPPC) released a comprehensive report based on an analysis of public and private insurance claims submitted by 330 million U.S. patients over a span of seven years, from 2017 to 2023.
According to the study, 10.93% of the 865,727 women prescribed chemical abortions using the drug mifepristone suffered a serious adverse event like sepsis or hemorrhaging within 45 days after taking the drug.
That number is significantly higher than the rate currently reported on the drug’s label.
While the FDA warning label for the two-drug mifepristone and misoprostol regimen acknowledges that roughly 85% of women who consume mifepristone and misoprostol report at least one adverse reaction, most commonly “nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness,” it states that less than 0.5% of women experience severe adverse events.
However, the rate of serious events reported by the EPPC study is twenty-two times as high as the FDA’s label.
In their report, the researchers urged federal officials to take the data seriously and restore regulations.
“Our research shows unequivocally that mifepristone abortion, as currently practiced in the U.S., is considerably more dangerous to women than is represented on the FDA-approved drug label,” the researchers said, arguing that the FDA “should immediately reinstate its earlier, stronger patient safety protocols to ensure physician responsibility for women who take mifepristone under their care, as well as mandate full reporting of its side effects.”
The EPCC report adds to a growing body of evidence suggesting that chemical abortions present serious dangers for women in addition to their lethality for the unborn.
A 2009 study from Finland found that chemical abortions were associated with an adverse reaction rate four times that of surgical abortions, including an increased risk of hemorrhage and incomplete abortion. In 2022, two Georgia women died after taking the abortion pill when they suffered incomplete abortions (a known risk) and contracted sepsis.
Despite the risks, chemical abortions have become increasingly common, especially as a workaround in states with laws protecting unborn lives, jeopardizing the effectiveness of pro-life legislation. In 2023, chemical abortions accounted for 63% of all abortions nationwide – up from 53% in 2020.
RELATED: Guttmacher Institute Estimates Over 1 Million Abortions in 2024 in Annual Nationwide Abortion Report
The increase in chemical abortions coincides with the removal of regulations on the prescription and distribution of the abortion pill over the past decade.
In 2016, the FDA implemented a new policy that widened the timeframe in which mifepristone could be prescribed during pregnancy. It also removed the requirement to report complications that do not result in death. In 2021, during the COVID-19 pandemic, the FDA permitted mifepristone to be prescribed online and distributed via mail. Local pharmacies were also authorized to dispense the drugs, and in January 2023, that permission was extended to retail pharmacies like Walgreens and CVS.
The increased availability of the drugs – together with an underreporting of complications – puts women at increased risk.
“Women are told that the complication rate for chemical abortions is minimal but hemorrhage, infection, and failure to identify rupturing ectopic pregnancies are the realities,” Randall K. O’Bannon, Ph.D., director of Education and Research at National Right to Life, said in a statement shared with Oregon Right to Life.
“Tracking these complications became more difficult in 2016 when the FDA decided that medical personnel and facilities only need to report deaths—not the complications arising from the use of the abortion pill mifepristone,” O’Bannon said.
And in light of the severity and frequency of the adverse reports, the EPCC researchers aren’t limiting their suggestions to restoring regulatory guardrails.
In their summary, they urged the FDA to “further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether.”
On Wednesday, more than 30 pro-life organizations signed onto a letter urging the Trump administration to reevaluate the abortion pill.
“The lives of women and unborn children and the rights of states depend upon it,” the signers said.
RELATED: Trump Admin’s Funding Freeze Triggers Permanent Closures of Planned Parenthood Facilities
Meanwhile, more research on the risks of mifepristone is forthcoming.
The EPCC stated that its April 28 report is “the first in a series investigating women’s health and abortion using real-world data.”
Oregon Right to Life believes in the sanctity of all human life from the moment of conception to natural death. Abortion ends the life of a genetically distinct, growing human being. We oppose abortion at any point of gestation. In rare cases, a mother may have a life threatening condition in which medical procedures intended to treat the condition of the mother may result in the unintended death of her preborn baby. At the same time, ORTL recognizes that modern medical practice has and will continue to increase the ability to save both the life of the mother and the baby. Read this and all our position statements here.
