FDA Data Reveals 151 Deaths Linked to Mifepristone—4 Times What FDA Claims
The drug is also tied to more than 4,000 reports of serious adverse side effects.
UPDATE 6/13: See below for email reply from the FDA. -Ed.
Mifepristone, the first of two drugs taken in the chemical abortion regimen, is associated with 151 death reports in a U.S. Food and Drug Administration (FDA) database, a review conducted by Restoration News revealed.
That total is more than four times the 36 mifepristone-related death reports the FDA acknowledges on its website.
The discovery comes on the heels of the Foundation for the Restoration of America's findings that about 11% of women who take mifepristone for abortions experience serious and potentially life-threatening side effects.
The FDA Adverse Event Reporting System (FAERS) database shows that mifepristone has been linked to more than 4,000 serious adverse events, including cases of sepsis, hemorrhage, uterine rupture, and ruptured ectopic pregnancy—and that's just what is publicly available.
(READ MORE: At-Home Abortion Pill is 22 Times More Dangerous Than FDA Admits: Report)
The Numbers
The FDA public dashboard is a searchable database of adverse event reports filed by drug manufacturers, health care providers, and consumers. While the system has its limitations, it is a key tool the FDA uses to monitor the safety and effectiveness of drugs and biological products.
In conducting its review, Restoration News queried the FAERS system for reports associated with mifepristone in all its forms: generic; the Mifeprex abortion pill; and Korlym, which treats symptoms of Cushing's syndrome.
The search returned 7,671 adverse event reports linked to mifepristone since the FDA first approved Mifeprex in September 2000.
Excluding fetal and infant deaths, 151 deaths were associated with the use of mifepristone.
Of that group, Restoration News identified 20 deaths linked to chemical abortions and another two associated with off-label use of Mifeprex. The remaining 129 deaths were associated with Korlym, though due to significant holes in the data, some deaths might have been inadvertently misattributed to the wrong group or excluded from the overall count.
The FDA does not specify on its website how many Cushing's-related death reports it has received for mifepristone since it approved Korlym in 2012. The 36 reports it acknowledges are all related to the drug's use for abortion.
This raises questions about the FDA's transparency concerning mifepristone. Where are the remaining 16 abortion-related reports, and why is there no acknowledgement of the numerous serious reports linked to the drug's other uses? As the debate over mifepristone's safety continues, shouldn't those adverse events be considered?
The FDA did not respond to Restoration News' request for comment by publication time, though a disclaimer on the FAERS website admits that "the potential underreporting of events" is one of the system's limitations.
Transparency Concerns
One abortion-related death report that was noticeably absent from the FAERS database was that of 41-year-old Georgia mother Candi Miller.
Miller, according to a ProPublica report, died on Nov. 12, 2022, after experiencing an incomplete chemical abortion. She reportedly obtained the pills online, took them at home, and then suffered for days until her family eventually found her unresponsive in bed.
An obituary for a Candi Shavon Miller of the same age and in the same state corroborates Miller's reported death date. FAERS, however, does not include a report for an adverse event on that date or any other that matches the details of Miller's case.
On the chance that she only took misoprostol, the second chemical abortion drug, Restoration News checked for matching reports associated with that drug as well. Again, there were none.
Given the well-publicized nature of Miller's death—the September 2024 report won the Pulitzer Prize—one would hope the FDA would have received a report by now.
Restoration News, however, is not the first organization to identify missing abortion-related reports in the FAERS system.
A 2021 study by the Charlotte Lozier Institute—the research arm of Susan B. Anthony List Pro-Life America—found that Planned Parenthood independently reported more than twice as many abortion drug complications as the FDA did for 2009 to 2010.
The same group also found that six states reported a total of 1,004 chemical abortion complications from 2020 to 2022, yet only 17 unduplicated reports were included in the FAERS database for the same period.
Katie Daniel, director of legal affairs and policy council for Susan B. Anthony Pro-Life America, said such major discrepancies underscore the unreliability of the FDA's current reporting standards.
"Over and over, we see studies that show that the real-world impact of these rules on actual women and girls is nothing like the rosy picture painted by the abortion industry—or even the drug label, which suggests that your risk is not zero, but it's low. That doesn't align with reality," Daniel told Restoration News.
FDA's Lax Standards
Where abortion is concerned, the general underreporting of data is a known issue. But the FDA compounded that problem in 2016 when it stopped requiring prescribers to report all serious adverse events to the drug manufacturer.
Since then, prescribers have only been required to inform the manufacturer of deaths. They also have no obligation to report those deaths directly to the FDA. That responsibility lies solely with the drugmaker.
Additionally, the FDA's current rules fail to consider that most patients will go to a hospital when experiencing a medical emergency, not the person who prescribed them the suspect drug. Although hospital staff may voluntarily report adverse events to the FDA, it is not mandatory for them to do so.
Meanwhile, the FDA's more recent removal of its in-person dispensation requirement for mifepristone allows patients such as Miller to obtain abortion pills online, take them unsupervised, and potentially die before ever stepping foot inside a medical office or hospital.
"The conditions that women are subject to today are night-and-day different from the neatly tailored studies that the abortion industry presented to [the FDA] 25 years ago, and we have to be honest about that," Daniel said.
She expressed optimism for the new leadership of Health and Human Services Secretary Robert F. Kennedy and FDA Commissioner Marty Makary, who pledged to review mifepristone's safety and effectiveness.
"There are a lot of people making a lot of money on the backs of American women, girls, and their babies, so we are hopeful that the disruptors who came to Washington with this administration will continue that pattern of actually speaking truth," she said. "And what they're going to find is horrifying."
(READ MORE: If Abortion Is Healthcare, Why Is Abortion Data Going Unreported?)
Email response from the FDA:
Hi Samantha,
On background:
The product-specific FDA webpage you reference provides information on Mifeprex and its approved generic, which are approved for medical termination of intrauterine pregnancy through 70 days gestation. This FDA webpage is not intended to include information on other reported uses of mifepristone that differ from the use of Mifeprex and its generic for medical termination of early pregnancy. For example, although Korlym (mifepristone) and its approved generic contain the same active ingredient as Mifeprex and its approved generic, they are approved for different uses, target different receptors, and have different strengths and use different dosing regimens. Korlym and the generic version of Korlym are approved for the treatment of Cushing’s syndrome.
Results from searching the FDA Adverse Event Reporting System (FAERS) Public Dashboard may vary depending on the parameters used to query the dashboard. In addition, the number of reports of deaths identified from the FAERS Public Dashboard differs from the number of cases referenced on FDA’s webpage regarding mifepristone for medical termination of pregnancy because during our review of adverse event reports regarding the use of mifepristone for this indication, we have eliminated duplicate reports (i.e., multiple reports for a single case or patient) and in some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details.
Further, the FAERS Public Dashboard includes only certain data fields and not all the data fields that are available to FDA staff. We note that adverse events that are reported with the use of mifepristone for medical termination of pregnancy cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient.
Emily G. Hilliard
Press Secretary
U.S. Department of Health and Human Services
