One of the researchers behind a recent study highlighting complications from abortion drugs claims the costs are far greater than what’s indicated on FDA-approved labels.
A study from the Ethics and Public Policy Center (EPPC) published at the end of April revealed that 10.93% of women using mifepristone for abortion experienced serious complications—like sepsis, infection, or excessive bleeding—within 45 days. This figure starkly contrasts with the <0.5% reported in clinical trials associated with FDA documentation.
The findings are based on a comprehensive analysis of data from the All-Wage Claims Database, encompassing over 865,000 mifepristone abortion cases from 2017 to 2023. Anderson, a key figure in this research, noted it as the largest study focused on the safety of abortion medications.
“You don’t have to take my word for it,” Anderson mentioned during a recent interview. “Our dataset covers Medicaid, Medicare, and various private insurers. The FDA has access to all public data and can acquire private records. Numerous insurance brokers provide these datasets. They could conduct their research, right?”
“We’ve sounded the alarm. Now, it’s up to you to investigate your own government health data and purchase private health information to understand the actual outcomes for real women,” he further remarked.
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The primary legal call to action resulting from the EPPC findings is for the FDA to reinstate former safety protocols concerning mifepristone, which is manufactured by Danco Laboratories under the brand name Mifeprex.
Mifepristone was fast-tracked for approval in 2000, classified under a process that allowed it to be labeled as a “serious or life-threatening condition” to account for unwanted pregnancies. The drug had to demonstrate higher effectiveness than surgical abortion.
The initial FDA-approved label for Mifeprex stated that it should only be used up to seven weeks of pregnancy. It mandated “several modest safeguards regarding women’s health.” These protections included:
- Three consultations by patients
- Prescriptions written only by doctors who understood the prescribing guidelines
- Administration of the drug in a facility that assesses pregnancy age and has a physician available to diagnose ectopic pregnancies
- A physician’s presence for surgical intervention in case of complications
- Patient access to medical facilities for necessary procedures, such as blood transfusions
However, these safeguards have been absent from drug approval for the past two decades.
Changes initiated during the Obama and Biden administrations have allowed women to acquire mifepristone through a single telehealth consultation since 2023, without the necessity of seeing a physician.
The FDA also necessitated that prescribers report serious adverse events other than death from 2016 onwards.
Some pro-abortion advocates argue that these regulations were essential for improving access to abortion services, specifically following the Supreme Court’s ruling that overturned Roe v. Wade.
The American Pro Life Association (Aaplog) warns that relaxed regulations around mifepristone may jeopardize women’s health, particularly due to the risk of undiagnosed ectopic pregnancies.
“Abortion medications can cause ectopic pregnancies and endanger women’s lives. Our study found that approximately one in 300 women diagnosed with an ectopic pregnancy had already taken the pill,” one of the researchers noted. “The FDA needs to restore stronger safety measures to prevent this.”
“The later a woman is in her pregnancy, the higher the risk of complications from abortion medications. By tightening restrictions based on pregnancy age and requiring accurate assessments before prescriptions, the FDA can mitigate risks to women’s health,” they concluded.
Anderson remarked on a recent program that it’s a straightforward request to reinstate regulations from the Clinton administration.
“This shouldn’t be a contentious issue. It’s about ensuring that if a woman is taking an abortion pill, the process is safe for her. And what about the safety of the baby? Returning to the standards of the Clinton era seems reasonable,” he stated.
Remarkably, what was considered standard practice during Clinton’s administration is now seen as a ‘radical’ policy in some circles.
Anderson also argued that reinstating mifepristone’s original safety protocols aligns with Trump’s agenda to “make America healthy again,” emphasizing that allowing states to set abortion laws shouldn’t enable pro-abortion states to influence policies nationwide.
The EPPC study is the first in a series examining women’s health and abortion through real-world data. A subsequent report is set to release soon, suggesting the failure rate for mifepristone abortion is at least 5.26%.
In 2023, medication abortions constituted 63% of all abortions in the US healthcare system, with an estimated 642,700 fetuses lost due to medication. This marks an increase from 53% in 2020 and 39% in 2017. The figures do not account for drugs accessed through unauthorized networks that bypass state law.
Mifepristone works by blocking the progesterone essential for sustaining a pregnancy, leading to the death of the fetus within the mother’s womb. Misoprostol is then used to induce contractions and expel the fetus.
According to Danco Research, “Cramping and bleeding are expected during pregnancy termination, but severe complications can occasionally arise.” They advise seeking immediate medical attention if serious symptoms occur.
