In a recent development, Robert F. Kennedy Jr., the Secretary of the Department of Health and Human Services (HHS), has directed the U.S. Food and Drug Administration (FDA) to conduct a comprehensive review of the abortion pill.
This decision comes in the wake of a startling study released last month, which suggested a higher complication rate than previously reported.
According to Breitbart, the study, conducted by the Ethics and Public Policy Center (EPPC), found that 10.93 percent of women who underwent mifepristone abortions experienced severe complications. These complications included sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following the abortion.
This percentage is alarmingly higher than the less than 0.5 percent reported in clinical trials on the FDA-approved drug label. The study analyzed data from an all-payer insurance claims database that includes 865,727 prescribed mifepristone abortions from 2017 to 2023.
Kennedy Jr. expressed his concern over the study's findings during a Senate Health, Labor, Education, and Pensions (HELP) Committee hearing. He stated, "It's alarming," and added, "I have asked Marty Makary, who is the director at FDA, to do a complete review and report back." He further suggested that the study indicates a need for a change in the drug's label.
During his confirmation hearing, Kennedy Jr. had pledged to study the safety of the abortion pill. Senator James Lankford (R-OK) highlighted how the FDA stopped requiring the reporting of all complications related to abortion drugs in 2016, except for deaths. He also noted that the FDA under Biden allowed abortion pills to be prescribed over telehealth and sent via mail, potentially endangering women with undiagnosed ectopic pregnancies and other complications.
Lankford raised the question of transparency, asking, "My question to you is, will FDA move to be able to actually give transparency to the American people and to say [mifepristone] is no different than any other drug? [That] we are not going to protect it just because [abortion] is political for some folks? People should know side effects of this drug and there should be reporting."
Kennedy Jr. responded, "Its against everything we believe in this country that patients or doctors should not be reporting adverse events. We need to know what adverse events are. We need to understand the safety of every drug mifepristone and every other drug. President Trump has made it clear to me that this is one of the things he has not taken a position yet on, a detailed position, but hes made it clear to me that he wants me to look at safety issues, and Ill ask NIH and FDA to do that.
Before the release of the study, Makary stated that he had "no plans to take action" to restrict the availability of mifepristone. However, he did not rule out the possibility of the FDA taking action if future data reveals dangers of the drug. He said, "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 theres a real signal, we cant promise were not going to act on that data.
The EPPC, following the results of the study, has called for the FDA to reinstate its earlier safeguards around mifepristone, which is created by Danco Laboratories and goes by the brand name Mifeprex. The drug was fast-tracked for approval in 2000 during the Clinton administration under a process that required unwanted pregnancy to be classified as a serious or life-threatening illness and the drug had to be proved more effective than surgical abortion.
The original FDA-approved drug label for Mifeprex from September of 2000 stated that the drug should be used through approximately 7 weeks of pregnancy. It also required several safeguards for womens health. However, these safeguards have been gradually eroded over the past two decades since the drugs approval.
Following actions from the Obama and Biden administrations, the drugs current Risk Evaluation and Mitigation Strategy (REMS), which has been in effect since 2023, allows women to obtain mifepristone with one telehealth visit with any approved healthcare provider, allows women to self-administer the drugs obtained from a mail-order pharmacy, and allows 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) have argued that these regulations need to be scrapped to increase access to abortions. This argument has gained traction especially in the wake of the Supreme Courts decision overturning the constitutional right to abortion, sending the issue back to states and their elected representatives.
However, the American Association of Pro-Life OBGYNs (AAPLOG) counters that relaxing regulations around mifepristone puts women at risk. They warn that a lack of in-person evaluation could put women at risk of having undiagnosed ectopic pregnancies or miscalculating how far along they are.
The studys authors previously told Breitbart News, 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 FDA must reinstate stronger safeguards to prevent this from happening.
They continued, The further along the woman is in her pregnancy, the larger and more developed her unborn child is, 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.
The study is the first in a series investigating womens health and abortion using real-world data. EPPC released a second report on Monday using the same insurance claims data, suggesting the real-world failure rate of a mifepristone abortion is at least 5.26 percent, which is double the failure rate reported on the FDA-approved drug label.
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.
In a medication abortion, mifepristone 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.
Danco Laboratories states 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 company advises seeking medical attention as soon as possible in these circumstances and adds, There is no information that use of Mifeprex and misoprostol caused these deaths. If you have any questions, concerns, or problems, or if you are worried about any side effects or symptoms, you should contact your healthcare provider.
The ongoing debate around the safety and regulation of the abortion pill underscores the need for transparency and comprehensive data. As the FDA embarks on its review, the hope is that it will prioritize the safety and well-being of women, ensuring that they are fully informed about the potential risks and complications associated with mifepristone.
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