CAPITOL HILL – In Washington, lawmakers are pressuring the Food and Drug Administration to examine safety questions surrounding the so-called abortion pill. That’s because a new study reveals women taking mifepristone could face extreme danger.
Mifepristone is now used for more than 60% of U.S. abortions. New information shows the rate of serious health risks is 22 times greater than the numbers reflected on the drug’s FDA-approved label. These statistics have lawmakers calling for a full FDA review.
“I have no plans to take action against mifepristone,” said FDA Commissioner Marty Makary. During that same interview, Makary admitted new data is coming that he hasn’t studied.
“Please don’t, don’t, don’t take this (drug) under any circumstances,” said Jamie Bryan Hall, who led the Ethics and Public Policy Center study. Hall is issuing that strong warning because the study found more than one in 10 patients who take mifepristone risk severe and sometimes fatal side effects.
“Something like an infection that could lead to sepsis. It could be hemorrhaging that could require a blood transfusion,” said Hall.
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Hall, the center’s director of data analysis, added that about half of the women who experience what’s called an “adverse event” will likely end up in the ER or hospitalized overnight. “It’s very risky for her in these situations to be doing this without proper care from a physician throughout the process.”
The extra attention paid to this report could be due to its huge database of health insurance claims. It includes nearly 900,000 prescribed abortions from 2017 to 2023.
That’s a stark contrast to the FDA-approved label, which relies on data from about 31,000 claims and shows less than 0.5% severe reactions—compared to the nearly 11% reported by the EPPC.
“I didn’t expect that we were going to find 22 times as many serious adverse events as the FDA did.”
When asked if the FDA is failing to protect women from significant harm, Hall replied, “Yes, the FDA has failed miserably in its responsibility to protect women from the risks of this pill.”
READ ‘Not Safe’: Women Face Life-Threatening Dangers from Abortion Pills, Latest Study Reveals
“The FDA rules that have been in place over the past several years— they’ve literally said, ‘We don’t want to know side effects unless the woman actually dies.’ But if she ends up in the emergency room, it ends up … where they don’t even tell us,” Hall said.
Oklahoma Republican Senator James Lankford told CBN News that no other drug receives this kind of treatment. He and other lawmakers are joining in the call for action.
“We want to be able to make sure that the FDA is actually looking at this and treating it fairly, and not having a political perspective because it’s about abortion,” Lankford said. “We’re asking the FDA, at a minimum, to reinstate the protocols that were in place when mifepristone was approved in 2000 and to look at our data very closely.”
Mifepristone’s producer, Danco, points out that more than five million U.S. women have taken the drug since the Clinton administration approved it almost 25 years ago.
Back then, however, patients had to take the two-pill regimen in a doctor’s office, followed by three check-up appointments.
Those safeguards have been loosened, especially during the Obama and Biden administrations.
“Now it’s actually possible for a woman to go online—or someone to go online on her behalf—fill out a little questionnaire, basically claiming that she’s healthy and that her pregnancy is not too far along, and get the pills sent to her in the mail,” said Hall. He and other critics believe mifepristone should be removed from pharmacy shelves.
READ NY Abortionist Indicted for Mailing Abortion Pills to Mother of Pregnant Teen in Louisiana
CBN News reached out to FDA Director Marty Makary for a reaction. His spokesperson referred us to Makary’s previous statement, which reads in part:
“There is an ongoing set of data that is coming into the FDA on mifepristone. So, if the data suggests something or tells us that there’s a real signal, we can’t promise we’re not going to act on that data.”
ABORTION PILL REVERSAL:
