The federal government is taking a closer look at the most widely used abortion medication in the country after new research suggests its risks may be more significant than previously reported.

According to CBN, Health and Human Services Secretary Robert F. Kennedy, Jr., has directed the Food and Drug Administration to conduct a comprehensive review of the abortion pill mifepristone, following a study that claims serious side effects are far more common than what the current label states.

The study, led by the Ethics and Public Policy Center, reports that nearly 11% of women using mifepristone suffer major health complications, a figure much higher than the 0.5% risk outlined on the FDA’s label. The drug is currently used in over 60% of abortions performed in the United States.

CBN News reported earlier in the week that more than 1 in 10 individuals who use mifepristone face severe or even deadly health reactions. These findings have prompted calls for action from federal leaders and lawmakers. Secretary Kennedy addressed the matter during a recent Senate hearing, where he was pressed by Missouri Senator Josh Hawley about the implications of the new data.

Senate Testimony Reveals Concerns Over Drug Safety

In his testimony, Kennedy called the findings presented in the report “alarming” and emphasized that the current labeling on mifepristone may no longer be accurate. He stated that the newly released information “indicates that, at the very least, the label should be changed.”

He has since formally requested a full reevaluation of mifepristone by the head of the FDA. This could lead to significant changes in how the drug is regulated and prescribed throughout the country. The process will include reviewing the safety data and potentially updating the warning label to reflect a more accurate risk profile.

The study at the center of this controversy was conducted by Jamie Bryan Hall and his team. Hall is a researcher at the Ethics and Public Policy Center, a think tank known for its work on health policy and ethics. His analysis has stirred debate across political and medical communities regarding the continued use of the pill under current labeling.

Lead Researcher Warns Against Self-Managed Use

Hall expressed grave concerns about the way mifepristone is being used, noting that in many cases, women may take the drug without sufficient medical supervision. He cautioned that adverse reactions often require intervention that cannot be handled without hospital-level care. “It’s very risky for her in these situations to be doing this without proper care from a physician throughout the process,” Hall said.

He also issued a stark warning against using mifepristone under any condition, saying, “Please don’t, don’t, don’t take this under any circumstances.” Hall’s comments reflect a strong belief that the risks associated with the medication outweigh the perceived benefits when appropriate medical oversight is lacking.

The data from the study shows that roughly half of the women who experience complications from the pill end up needing emergency treatment or overnight hospitalization. This statistic stands in sharp contrast to the original FDA data, which reported far fewer serious complications and had served as the foundation for the agency’s guidance on safe usage.

Lawmakers Push for Further Oversight

In the aftermath of the new report and Secretary Kennedy’s order, lawmakers have intensified calls for oversight. Many are urging the FDA to ensure that mifepristone’s label and approval status reflect the most up-to-date science. While the drug has been approved for medical use since 2000, its expanded distribution and increasing reliance have triggered both political and medical debates.

The review could open the door for changes, including stronger guidance for prescribers, new safety protocols, or limitations on how the drug is dispensed. Some elected officials say the federal government must revisit its regulatory decisions when credible new evidence emerges.

At present, mifepristone remains a central element of abortion access in the United States. Its ease of use and availability have made it a commonly chosen option, particularly following changes to abortion policies across various states. But critics argue that ease should not come at the cost of women’s health and safety.

Implications for Abortion Access Nationwide

Any changes to the FDA’s labeling or approval could have widespread impacts on abortion providers and patients alike. Medical professionals who prescribe the drug may be required to adjust their practices to meet new federal guidelines, should the review result in retraining, restricted usage, or updated risk advisories.

Advocates on both sides of the abortion debate are closely watching this review process. Supporters of access to mifepristone warn that overly strict rules could limit reproductive choices, while opponents argue that patient safety must be prioritized regardless of political sentiment.

For the FDA, the task now is to reexamine its past assessments and determine whether the current labeling adequately reflects the drug’s real-world risk. With Secretary Kennedy pushing for prompt action, a decision may be announced within the coming months.

Agency Begins Responding to Kennedy’s Request

As the FDA begins its formal inquiry, Kennedy has also indicated that the agency should consider revising existing policies about how adverse event data is tracked and reported. Some critics have argued that incomplete follow-up data may have contributed to underreporting past complications.

While the review is ongoing, supporters of the effort point out that Kennedy's move is part of a larger push to ensure all medications approved for public use are held to rigorous safety standards. If the agency finds that the estimated complication rates are indeed higher than previously known, it could set a precedent for more frequent post-market surveillance of high-impact pharmaceuticals.

Regardless of the outcome, the FDA’s decisions will likely have a ripple effect, reshaping both regulatory practices and the broader public conversation surrounding medical abortion and informed consent. More updates are expected from the agency as the review progresses.