We could see results of the long-awaited U.S. Food and Drug Administration (FDA) safety study on the abortion pill mifepristone as early as this month and the report cannot come soon enough.
The FDA study of the chemical abortion pill would come after years of requests from pregnancy help and pro-life organizations alon with Republicans in Congress for an FDA study, as well as thousands of women negatively impacted medically by the pill.
Chemical abortion makes up at least 63% of abortions in the U.S., according to data from the Guttmacher Institute. It is four times more dangerous than a surgical abortion.
Mifepristone is the first drug taken to cause a chemical, or medication, abortion. The drug causes progesterone to be depleted within the pregnancy, ultimately starving the baby in the womb. The second pill, misoprostol, is taken hours later, causing uterine contractions to dispel the pregnancy. Side effects of mifepristone may include hemorrhaging/heavy bleeding, fever, infection, incomplete abortion, and even death.
Safety concerns are the reason Mifepristone has a REMS classification, one of roughly 73 drugs to have the designation, only a fraction of the thousands of prescription medications approved by the FDA. Mifepristone also has an FDA Black Box Warning, the highest level of safety warning.
The Trump administration has been working for months on a study of mifepristone safety issues, as stated in a letter back in September of 2025 from Health and Human Services Secretary Robert F. Kennedy Jr. to Republican state attorneys general.
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Last year in June then FDA Commissioner Marty Makary said he was “committed” to an in-depth look at mifepristone following the release of the Ethics and Public Policy Center study in April 2025 showing that one in 10 women who ingest mifepristone will suffer some serious medical episode within 45 days – 22 times more often than its FDA label indicates, and 4.7 % needing an emergency room visit after taking mifepristone.
Mifepristone has been on the market since 2000. And thanks to the Obama and Biden administrations, there has been little oversight in recent years, making access easier than ever - with apparent disregard for the risks and complications to a woman’s health. More abortion pills have been sold since the Dobbs ruling overturned Roe v. Wade, at times contravening laws in life states. During the Biden administration FDA's REMS (Risk Evaluation Management Strategy) requiring an in-person doctor visit was eliminated for mifepristone, even though it had been in place since 2000.
The FDA has documented at least 4,000 instances of serious adverse events related to the abortion pill, including more than 1,000 women who required hospitalization. As of the end of 2018, there had been 24 reported deaths of women in the U. S. associated with abortion pills.
The FDA’s own data shows that between the drug’s approval in 2000 and 2022 at least 32 women have died following mifepristone use.
Still, the fight against the dangers of the pill push onward.
Heartbeat International, the largest network of pregnancy help organizations in the U.S. and globally, had weighed in on the FDA v. Alliance for Hippocratic Medicine case in 2024 by filing an amicus brief opposing the FDA’s for putting women’s lives at risk with the 2023 Biden FDA REMS. Despite the voices of medical professionals and their factual findings, the court ruled pro-life doctors had no say against the FDA’s decision. Heartbeat has also filed briefs in the State of Louisiana et al v. Food and Drug Administration supporting Louisiana’s bid to reinstate the safety standards for mifepristone.
U.S. Senator Josh Hawley (R-Mo.) introduced legislation this past spring to ban the abortion pill completely. The bill would withdraw the FDA’s approval of mifepristone for abortion, allowing distribution and labeling mifepristone for pregnancy termination violations of the Federal Food, Drug, and Cosmetic Act, and allow women harmed by the actions of the to sue manufacturers for damages. Hawley also opened an investigation earlier this year into the business practices of chemical abortion drug manufacturers Danco Laboratories and GenBioPro given the growing body of evidence showing that women are suffering alarming rates of adverse effects from the drug.
Despite the glaring safety concerns with mifepristone, Planned Parenthood’s website continues to tout the pill as safe as Tylenol, Viagra and penicillin. Additionally, in a January 2026 deposition in the People of the State of California v. Heartbeat International & Real Options case abortionist and Danco Laboratories paid consultant Mitchell Creinin oddly could not answer whether the abortion pill is indeed as safe as Tylenol. California is suing Heartbeat and its affiliate over sharing information about Abortion Pill Reversal.
In anticipation of the FDA findings driving possible tightening of regulations for mifepristone abortion advocates are pushing misoprostol-only abortion, a step further into danger for women. This, while abortionist Creinin stated in the deposition that misoprostol cannot be used by itself for abortions because it is not FDA approved for abortion.
When a scenario arises where a woman is harmed by taking the abortion pill, abortion advocates often dishonestly blame the laws regulating abortion that give women “no other choice” but to order the pill when they cannot easily obtain an abortion in certain states. It remains to be seen whether they will blame the FDA if the truth of mifepristone is further exposed by the FDA report.
Another atrocity surrounding mifepristone in its current largely unregulated state is that is being used for coerced or forced abortion, with increasing reports surfacing. This pill is being used against women, not for their benefit.
Tweet This: Abortion pill mifepristone is being used against women, not for their benefit.
Heartbeat International has released an abortion pill poisoning tracker, highlighting incidents across the country in which women were either forced into taking the abortion pill or poisoned by its contents. Heartbeat has also added a page to its Abortion Pill Rescue Network website to address coerced and forced abortion through the chemical abortion pill.
The FDA’s mission is “promoting and protecting public health.” Mounting evidence related to chemical abortion drug mifepristone demonstrates it is past time for the FDA uphold its mission and make it known what is happening to women because of this terrible drug.
Editor’s note: Heartbeat International manages the Abortion Pill Rescue® Network (APRN) and Pregnancy Help News. Heartbeat is currently the subject of two lawsuits concerning sharing information about Abortion Pill Reversal.
