The publication of a new study analysing over 800 000 medical abortion cases that has raised questions about the safety profile of mifepristone, a drug commonly used to terminate early pregnancies, is very notable said Dr Albu van Eden CEO or Doctors For Life International.
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%.
The study highlights that over the past two decades, safety regulations around the drug have been relaxed and that during the Covid-19 pandemic in 2021 the FDA further loosened regulations in the US, allowing mifepristone to be delivered by mail without any in-person examination. The pandemic also spurred a surge in demand for telemedicine in South Africa, including for abortion services. Abortion provider Marie Stopes South Africa proclaims on its website: “We have safely assisted over 20 000 women across South Africa with our telemedicine services.” On the web page Marie Stopes advertises “safe and discrete pills delivered to your door” for women up to nine weeks pregnant after a “remote consultation with our nurses” which is “only 20 minutes long”. The pills delivered are mifepristone and misoprostol.
Responding to questions from Gateway News, Dr Van Eden said: “We’ve made an issue [about the use of mifepristone for abortions] for some time already. I must say that internationally there hasn’t been much reaction. We were just ignored and nobody bothered.
“But now, suddenly, the international attitude seems to be turning to more pro-conservative values and people are starting to look more critically at the drug.
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“Mifepristone is the old RU486 which was originally developed in France and for a long time it was considered a horrible tablet because it causes abortion late in pregnancies. Originally, when France developed it, everybody thought it was a horrible thing and we [in SA] wouldn’t consider taking it. Even overseas it was not taken.
“But then, once abortion on demand was legalised in South Africa [in 1997], suddenly people started using it and it’s being handed out,” he said.
Van Eden said he believes the EPPC study which raises serious questions about the safety profile of mifepristone, “is the beginning of more literature that will be coming out”.
“At least this is a very solid piece of work with a large cohort of people on which they did the experiment, which makes it very noteworthy.”
Asked whether DFL would draw the attention of SA health authorities to the study, he said: “We would like to. We’ve got to discuss it. I’m not sure whether we would not first wait for one more two more articles to appear. But we are keeping our finger on the pulse with this.”
In a report on the EPPC study, Christian Today writes:
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.
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