Robert F. Kennedy Jr., the Director of the Department of Health and Human Services (HHS), announced on Wednesday that he has tasked the U.S. Food and Drug Administration (FDA) with performing a “full review” of abortion drugs. This decision follows a study released last month that indicated concerning complication rates associated with these medications.
Research conducted by the Ethics and Public Policy Center (EPPC) revealed that 10.93% of women who underwent a mifepristone abortion—often the first in a two-drug regimen—faced severe complications such as sepsis, infections, or significant bleeding within 45 days post-abortion. This figure stands in stark contrast to the less than 0.5% complication rate noted in clinical trials documented on FDA-approved drug labels. The analysis was based on data from the All-Wage Claims Database, which included 865,727 prescriptions for mifepristone from 2017 to 2023.
“That’s quite striking,” Kennedy Jr. remarked during a Senate Health, Labor, Education and Pension Committee hearing when asked about the study’s findings by Senator Josh Hawley (R-MO).
He added, “We have requested FDA Director Marty McCurry to provide a comprehensive review and report.”
“The findings clearly indicate a need to amend drug labels,” Kennedy Jr. informed the Senator.
During his confirmation hearing, Kennedy Jr. made commitments to evaluate the safety of abortion medications. Senator James Lankford (R-OK) noted that since 2016, the FDA has not included reports of complications related to abortion medications, casting doubt on their thoroughness. He expressed concerns about the current regulations allowing abortion medications to be prescribed through telehealth and sent via mail, which could pose risks in case of undiagnosed conditions like ectopic pregnancies.
Lankford inquired, “Isn’t it the responsibility of the FDA to ensure transparency for Americans regarding mifepristone, just as with any other medication? People should be aware of the drug’s side effects.”
“It fundamentally contradicts our principles if patients and doctors aren’t reporting adverse events,” Kennedy Jr. responded. “Understanding the safety profiles of all drugs is crucial, including mifepristone.” He mentioned that President Trump has emphasized the importance of safety evaluations in drug approvals.
Before the study’s release, Dr. Marty Makary mentioned that the FDA had taken “no action” to restrict mifepristone’s availability but indicated a possible reassessment if future data suggests risks.
Calls for action following the EPPC study urge the FDA to reinstate earlier safeguards for mifepristone, which was marketed under the brand name Mifeprex. The drug gained approval quickly in 2000, at a time when it had to prove greater effectiveness than surgical abortion, classified as a serious medical condition.
Initially, the FDA’s labeling for Mifeprex, issued in September 2000, indicated that the drug should be administered within seven weeks of pregnancy and included various safeguards for women’s health. These included stipulations for three office visits, prescriptions by informed doctors, and protocols for potential complications. However, these precautions have been relaxed over the past two decades.
Changes enacted by the Obama and Biden administrations mean that as of 2023, women can obtain mifepristone through a single telehealth appointment without necessarily seeing a physician in person. Additionally, the 2016 requirement for prescribers to report significant adverse events, other than death, was lifted.
Organizations advocating for abortion have defended these revised regulations, arguing that they promote access to abortion amidst changing legal landscapes, especially after the Dobbs v. Jackson decision, which shifted abortion regulations back to state control.
The American Association of Pro-Life Obstetricians and Gynecologists has raised alarms regarding loosened regulations around mifepristone, asserting that they could endanger women’s health. They emphasized that inadequate evaluations could lead to serious misdiagnoses, such as undetected ectopic pregnancies.
“Abortion medications can trigger dangerous situations like ruptured ectopic pregnancies, jeopardizing women’s lives,” a study author mentioned, noting that around one in 300 women using these drugs might unknowingly have an ectopic pregnancy. Strengthening access requirements and ensuring accurate gestational assessments before prescriptions could mitigate such risks.
This study represents the first installment in an ongoing examination of women’s health and abortion through real-world data. The EPPC plans to issue additional reports, with one upcoming release indicating a potential failure rate for mifepristone abortion at no less than 5.26%.
In 2023, medication abortions constituted 63% of all abortions recorded within formal U.S. healthcare, translating to approximately 642,700 pregnancies ending through these methods, a rise from past years as reported by the Guttmacher Institute.
In medication abortion, mifepristone blocks progesterone, which is essential for maintaining pregnancy. Following this, another medication, misoprostol, initiates contractions to expel the pregnancy. While the side effects of bleeding and cramping are expected, serious complications can arise, and patients are advised to seek medical attention promptly if they experience severe issues.
