A new study analysing over 800,000 medical abortion cases has raised questions about the safety 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 side effects — a figure that significantly exceeds the US Food and Drug Administration’s (FDA) current estimate of less than 0.5%.
Mifepristone, which was first approved by the FDA in 2000 for use in combination with misoprostol, has been promoted as a “safe and effective” method of medical abortion.
Over the past two decades, 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 2.84% underwent surgery to finalise the abortion.
These rates, researchers argue, stand in sharp contrast to the data often cited by the FDA, which is based 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 extended the approved use of mifepristone from seven to 10 weeks of pregnancy in 2016 and eliminated the requirement for three in-person visits.
During the COVID-19 pandemic in 2021, the agency further loosened regulations in the US, allowing mifepristone to be delivered by mail without any 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 women who suffer serious medical consequences because of the abortion pill.”
The FDA has acknowledged in the past that reducing in-person medical oversight could lead to an increase in emergency care visits but maintains that mifepristone, when used as directed, remains “a safe and effective” option for most patients seeking an early abortion.
As mifepristone remains at 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 in the US.
