A recent study from the Ethics and Public Policy Center (EPPC) has revealed alarming data about the safety of the abortion pill, suggesting that the rate of complications is 22 times higher than previously reported.
The study, released on Monday, found that nearly 11% of women who underwent mifepristone abortions experienced severe complications such as sepsis, infection, hemorrhaging, or other serious adverse events within 45 days of the procedure. This is a stark contrast to the less than 0.5% complication rate reported in clinical trials on the FDA-approved drug label.
According to Breitbart, the study is the largest of its kind on the abortion pill. The authors, EPPC President Ryan T. Anderson and Director of Data Analysis and Fellow Jamie Bryan Hall, based their findings on an analysis of data from an all-payer insurance claims database.
This database includes 865,727 prescribed mifepristone abortions from 2017 to 2023, providing a real-world perspective on the drug's effects. The data was scrutinized by a team of data scientists, analysts, engineers, and a clinical team of board-certified obstetricians and gynecologists.
"The abortion pill is not like Tylenol. We find that one out of every ten women who takes the abortion pill will suffer from a serious adverse event, like hemorrhage or infection, soon afterward. A third to a half of these women will then go to the ER or even be hospitalized as a result," Anderson and Hall told Breitbart News. "This is unacceptable. We can be confident in our results because we're using insurance claims data from more than 865,000 cases to track the real-world experiences of the women who have been harmed by the abortion pill."
The current FDA-approved drug label for mifepristone is based on the results of ten clinical trials with a total of 30,966 participants, where less than 0.5 percent experienced serious adverse events. The current drug label also includes data from as early as 1983, according to the study.
The researchers identified a total of 865,727 mifepristone abortions for a total of 692,873 women, including 566,446 women who had one such abortion and 126,427 women who had multiple abortions. From these cases, they found a total of 94,605 adverse events related to medication abortions.
"Simply stated, mifepristone, as used in real-world conditions, is not 'safe and effective.' Our real-world post-market observational study of mifepristone is, to our knowledge, the most comprehensive study of chemical abortion safety ever conducted in the U.S.," the authors stated.
The study's findings are particularly significant given the political climate surrounding the abortion pill. Over the past decade, Democrat presidential administrations have progressively deregulated the drug since its initial approval by the Clinton administrations FDA in 2000.
In a medication abortion, mifepristone also called by the brand name Mifeprex created by Danco Laboratories blocks the action of progesterone, which the mothers body produces to nourish the pregnancy. When progesterone is blocked, the lining of the mothers uterus deteriorates, and blood and nourishment are cut off to the developing baby, who then dies inside the mothers womb. The drug misoprostol (also called Cytotec) then causes contractions and bleeding to expel the baby from the mothers uterus.
The original FDA-approved drug label for Mifeprex from September of 2000 said the drug should be used through approximately 7 weeks of pregnancy. Its use also required several modest safeguards for womens health, the study notes. However, these safeguards have been gradually eroded over the past two decades since the drugs approval.
The Obama and Biden administrations have made significant changes to the drugs current Risk Evaluation and Mitigation Strategy (REMS), which has been in effect since 2023. These changes include allowing women to obtain mifepristone with one telehealth visit with any approved healthcare provider, allowing women to self-administer the drugs obtained from a mail-order pharmacy, and allowing women to take the drugs up to ten weeks gestation instead of seven weeks. The FDA also stopped requiring prescribers to report serious adverse events other than deaths in 2016.
Pro-abortion groups like Planned Parenthood and The American College of Obstetricians and Gynecologists (ACOG) argue that these regulations need to be scrapped to increase access to abortions. However, the American Association of Pro-Life OBGYNs (AAPLOG) warns that relaxing regulations around mifepristone puts women at risk. They caution that a lack of in-person evaluation could lead to undiagnosed ectopic pregnancies or miscalculations of gestational age.
"The abortion pill can cause an ectopic pregnancy to burst and put the womans life in danger. Yet we find that roughly one in 300 women who takes the pill in the real world is diagnosed with an ectopic pregnancy after she has already taken the pill," the studys authors told Breitbart News. "The FDA must reinstate stronger safeguards to prevent this from happening."
The authors also noted that the further along a woman is in her pregnancy, the greater the risk of complications from the abortion pill, such as retained fetal parts. "By tightening gestational age limits and requiring the doctor to accurately assess gestational age before prescribing the pill, the FDA can reduce the risk of harm to the woman."
When asked how the number of serious adverse events they recorded for mifepristone compares to other FDA-approved drugs, the authors explained that "a lot depends on what underlying condition the drug is intended to treat."
"Drugs for moderate to severe conditions that do have higher serious adverse event rates are almost always prescribed because there are no alternatives. But even then, we also require stricter protocols and safety measures, and require that they be administered under a physicians care," they replied.
"We accept higher risks in cancer drugs than in Tylenol, for example. Advocates frequently claim that the abortion pill is just as safe as Tylenol. But 1 in 10 women taking the abortion pill experience a serious adverse event, whereas its in the range of 1 in 10,000, conservatively speaking, for Tylenol when taken as directed," they continued. "And unlike other drugs, we no longer require the safety protocols and a physicians carethat were originally requiredbecause the Obama and Biden FDAs removed them."
Despite the alarming findings of the study, Danco Laboratories maintains on its website that "although cramping and bleeding are an expected part of ending a pregnancy, rarely, serious and potentially life-threatening bleeding, infections, or other problems can occur following a miscarriage, surgical abortion, medical abortion, or childbirth.
The studys findings carry significant weight, given that medication abortions have become the most common method of abortion in the U.S. after the Supreme Court overturned . In 2023, medication abortions accounted for 63 percent of all abortions within the formal U.S. healthcare system meaning an estimated 642,700 unborn babies died in medication abortions, according to the pro-abortion Guttmacher Institute. The percentage was up from an estimated 53 percent in 2020 and 39 percent in 2017. The report did not account for abortion pills obtained through underground national and international networks, including those that send pills to women in states with abortion restrictions.
The studys authors ultimately call on the FDA to reinstate the original patient safety protocols required when mifepristone was first approved and contends that "doing so will likely reduce the harms to women and permit better monitoring to determine whether this drug should remain on the market.
"Our research shows unequivocally that mifepristone abortion, as currently practiced in the U.S., is considerably more dangerous to women than is represented on the FDA-approved drug label," they wrote.
"The FDA should immediately reinstate its earlier, stronger patient safety protocols to ensure physician responsibility for women who take mifepristone under their care, as well as mandate full reporting of its side effects," they continued. "The FDA should further investigate the harm this drug causes to women and, based on objective safety criteria, reconsider its approval altogether. Women deserve better than the abortion pill.
The authors wrote that the paper is the first in a series investigating womens health and abortion using real-world data.
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