The FDA reports serious adverse events in “less than 0.5 percent” of cases involving mifepristone, according to its drug label.
The reality is that almost 11 percent – 10.93 percent of users – experienced sepsis, infection, hemorrhaging or another serious event within 45 days following a mifepristone abortion, according to a survey released Monday by the Ethics and Public Policy Center.
That painful and scary reaction from the abortion pill is roughly 22% higher than the FDA’s estimate.
The survey is the largest-known study of the abortion pill. It is based on analysis of date from an all-payer
insurance claims database that includes 865,727 prescribed mifepristone abortions from 2017-2023.
By comparison, FDA studies rely on the results of only 10 clinical trials with a total of 30,966 participants, according to the survey.
Using the reach of social media, women are sharing their traumatic experiences when they take the two-step abortion pills, mifepristone and misoprostol. The first pill ends the pregnancy by blocking progesterone to thin the uterine lining. The second pill causes contractions to expel the fetus.
Ryan Anderson, who is president of EPPC and a co-author of the study, told Washington Watch women are not dealing with minor side effects, like upset stomach, from the pills.
"These are serious adverse events, 22 times higher than what the FDA claims, and this is based on real-world data," he pointed out.
Safety was once a focus
Government oversight, or lack thereof, is directly responsible for the surge in negative outcomes, Anderson told show host Jody Hice.
“Both the Obama and the Biden administrations got rid of most all of the major safety protections that the FDA originally required when they approved of the pill. So, what we're calling on the Trump FDA to do is, for right now, just reinstate those original safety provisions,” Anderson said.
Guard rails could include required physician oversight – with in-office visits – while women take the pills, and no more mail-order pills and no telehealth visits.
“Women deserve to know the truth about the abortion pill, and women deserve to have safe, quality healthcare,” Anderson said.
Currently, the FDA Medication Guide tells women to expect cramping and bleeding as an expected part of abortion but that “life-threatening bleeding, infections, or other problems following a miscarriage, surgical abortion, medical abortion, or childbirth” are rare.
Women should contact their healthcare provider if they experience heavy bleeding, abdominal pain, “feeling sick” or fever after taking mifepristone, the FDA says.
In addition to the small sample size, FDA guidance misses major potential complications because of poor math, Anderson said.
“The original FDA studies, what they did was one study would look at ER visits. One study might look at hemorrhaging. One study might look at sepsis. Then they would add all of those things up together as if all of the studies had looked for all of the serious adverse events.
“So, there's a numerator-denominator problem here,” he continued. “The numerator was way too small, and then they inflated the denominator, ending up with a much smaller fraction.”
It’s possible the FDA testing for mifepristone was politically driven, Anderson said.
“Maybe this was politicized. Maybe this was just an honest statistical mistake. One way or the other, they got their math wrong. But then what we saw in the Obama years and now most recently from the Biden administration, it was clearly politicized medicine to get rid of these original safety provisions.”
When women’s health and safety was the focus – not facilitating abortion – use of mifepristone required three in-office doctor visits before the pills were prescribed then later follow-up visits to monitor the patient through the process, Anderson said.
“They’re now doing it with online telehealth and mail-order abortion pills across state lines. This isn't looking out for the best interests of women, certainly not looking out for the best interests of their unborn children,” he said.
Carol Tobias, president of National Right to Life, told AFN earlier this month that abortion industry leaders are encouraging women to take mifepristone by comparing the abortion pills to Tylenol.
“They want women to just swallow the pill and assume they can go on with their lives,” Tobias said. “It doesn't work that way. The pills are painful. The women are seeing sometimes the body of the unborn child that is expelled.”
Supporters of abortion and abortion providers have long claimed that the abortion pill is safe. Jamie Bryan Hall, EPPC’s director of analysis and co-author of the study along with Anderson, told AFN that absolutely is not true.
"Among those who experience one of these events, about half will end up or in the ER in the hospital as a result of that," said Hall. "So it's definitely not even remotely like taking a Tylenol."
Hill recommended pro-lifers pass this information on to women considering abortion. If they were aware, Hall said they'd think twice before taking the abortion pill.
"So, it's absolutely essential that that those working at crisis pregnancy centers or otherwise counseling these women know the risks, share the information, help them make good decisions for life," said Hall. "Women need to know this.”
Politicization of abortion
The most conservatively estimated studies here would be something like 1 in 10,000 patients taking Tylenol will end up with a serious adverse event. The study finds it’s actually closer to 1 in 11.
“That's not what we're seeing with Tylenol. This has been politicized. The Obama and Biden administrations didn't act on new data to get rid of safety provisions. They did this simply to make the abortion pill more accessible,” Anderson said.
Further evidence of politicization exists with increased availability of mail-in abortion pills, Anderson said.
“Many blue states, pro-choice states, are mailing the abortion pill across state lines,” he said.
If the Trump administration is to follow through on promises to "Make America Health Again," there’s only one course of action for abortion pills moving forward, Anderson said.
“[Trump] promised to undo the Biden- and Obama-era bad regulations and policies, and he promised to leave abortion to the states. Well, you can't leave it to the states if California is mailing abortion pills to the other 49 states.
“You can't make America healthy again if you have a 10.9% rate of serious adverse events, and you can't undo all the stupid things Biden and Obama did unless you also undo what they did to the abortion pill.”
