A recent study analysing over 800,000 medical abortion cases has raised questions on the protection profile of mifepristone, a drug commonly used to terminate early pregnancies.
The research, published by the US-based Ethics and Public Policy Center (EPPC), reports that 10.93% of users encountered severe uncomfortable side effects — a figure that significantly exceeds the US Food and Drug Administration’s (FDA) current estimate of lower than 0.5%.
Mifepristone, which was first approved by the FDA in 2000 to be used together with misoprostol, has been promoted as a “protected and effective” approach to medical abortion.
Over the past twenty years, various safety regulations surrounding the drug have been relaxed, including requirements for a prescriber, in-person physician visits and comprehensive complication reporting.
The EPPC study analysed 865,727 insurance claims related to mifepristone-induced abortions between 2017 and 2023.
According to the findings, 3.31% of patients experienced haemorrhaging, 1.34% had serious infections, and 0.1% developed sepsis. Almost 5% of users required emergency room care, and a couple of.84% underwent surgery to finalise the abortion.
These rates, researchers argue, stand in sharp contrast to the information often cited by the FDA, which is predicated on a limited pool of 30,966 subjects across 10 clinical trials – some dating back nearly half a century ago and conducted under more stringent safety conditions than those currently in place.
Following a proposal by Danco Laboratories, the FDA prolonged the approved use of mifepristone from seven to 10 weeks of pregnancy in 2016 and eliminated the requirement for 3 in-person visits.
During the COVID-19 pandemic in 2021, the agency further loosened regulations within the US, allowing mifepristone to be delivered by mail with none in-person examination.
Critics argue that such changes have compromised patient safety.
EPPC president Ryan T Anderson said: “This study is the statistical equivalent of a category 5 hurricane hitting the prevailing narrative of the abortion industry.
“It reveals, based on real-world data, the shocking number of girls that suffer serious medical consequences due to the abortion pill.”
The FDA has acknowledged up to now that reducing in-person medical oversight may lead to a rise in emergency care visits but maintains that mifepristone, when used as directed, stays “a protected and effective” option for many patients in search of an early abortion.
As mifepristone stays on the centre of ongoing legal and political debates following the Supreme Court’s 2022 decision to overturn Roe v. Wade, this latest study may influence future regulatory decisions and healthcare protocols related to abortion access within the US.
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