New Research Shows Abortion Pills' Real Risk | Opinion

Taking abortion pills is "safer than taking Tylenol."

So claimed ANSIRH, an abortion advocacy and research organization based at University of California San Francisco, in an X post on April 14. "Anti-abortion misinformation has exploded since the end of [Roe v. Wade]," the group wrote. "Anti-abortion activists want you to believe that abortion pills are dangerous, but in reality, they're safer than taking Tylenol."

But a report on new data released this week by my colleagues Ryan Anderson and Jamie Bryan Hall at the Ethics and Public Policy Center proves otherwise. Their analysis of insurance data from an all-payer insurance claims database indicates that more than 10 percent of women who chose medication abortion experienced an adverse effect—including sepsis, infection, and severe hemorrhaging—requiring a visit to an emergency room. The new data track closely with similar figures in England and Wales that showed much the same results.

"Medication abortion" refers to the abortion drug combination of mifepristone and misoprostol. Mifepristone is a synthetic steroid that prevents the nutrients necessary for fetal growth from reaching the unborn child, resulting in death. The second drug in the regimen, misoprostol, induces intense uterine cramping to expel the fetal remains.

Mifepristone was developed by the French pharmaceutical company Roussel Uclaf in the 1980s. Also known as RU-486, mifepristone is marketed in the U.S. under the brand name Mifeprex.

When it approved mifepristone, the FDA used an accelerated approval process known as "Subpart H," a category designated specifically for medications that "treat serious or life-threatening illnesses." Conditions that had previously qualified for the "H" designation included HIV/AIDS, cancer, and multiple myeloma—yet inexplicably pregnancy (which indicates that a woman's reproductive system is healthy and functioning) somehow also qualified.

At the same time, the FDA's 2000 approval of mifepristone implicitly acknowledged the drug's risks by placing safety requirements on its use. These restrictions included mandating that only physicians could prescribe the mifepristone, imposing a seven-week gestational limit, and mandating that the pregnant woman participate in three separate in-person physician office visits—the first, so the doctor could personally administer the drug; the second, three days later, to personally administer misoprostol to induce the uterine cramping; and the third, at approximately two weeks post-abortion, to confirm that no fetal body parts or pregnancy tissue remained in the uterus and that bleeding had subsided. Finally, the FDA required providers of the abortion pill to report all adverse health events, like infection or excessive bleeding—not just deaths.

In 2016, under the Obama administration, the FDA announced it had approved "major changes" to the dispensing of mifepristone that removed the initial protocols. The FDA eliminated the requirement for both follow-up appointments. It also changed the dosage directives and lifted the prohibition on non-doctors prescribing and administering mifepristone. The FDA also increased the gestational age limit of the unborn child being aborted from seven to ten weeks, and completely eliminated the previously required "non-fatal adverse event reporting," meaning that only deaths from mifepristone would be reported, not injuries to the woman—even serious ones.

During the COVID pandemic, the FDA did not enforce the sole remaining in-person appointment required to dispense mifepristone; following the election of President Biden, the agency permanently dropped the in-person appointment requirement altogether, permitting women to receive the abortion drug through the mail.

The new EPPC analysis shows a frightening pattern of harm caused to women by mifepristone. Women who undergo a medication abortion are more likely to present in an emergency room after taking the pills than a woman who has had a surgical abortion. Adverse outcomes range from sepsis caused by the retention of fetal tissue to fallopian tube rupture in women who have an ectopic pregnancy (a pregnancy that implants outside the uterus). It is because of those very risks that the FDA required medical oversight of mifepristone in the first place—to minimize the threat of serious side effects for pregnant women.

By restoring the seven-week gestational age limit for chemical abortions and reinstating the mandatory doctor visits—along with the requirement to report complications and not just deaths—the FDA will better fulfill its mandate to protect Americans from harm. Mifepristone should be treated as the potentially dangerous drug that it is—not a political football.

Mary FioRito is an attorney and the Cardinal Francis George Fellow at the Ethics and Public Policy Center. She resides in Chicago with her husband and three daughters.

The views expressed in this article are the writer's own.