Charles Esther
The U.S. Food and Drug Administration (FDA) has confirmed it will conduct a review of the abortion drug mifepristone following new studies questioning its safety.
FDA Commissioner Marty Makary expressed his commitment to this review in a June 2 letter addressed to Missouri Senator Josh Hawley, who has called for stricter oversight of abortion pill safety regulations.
Makary emphasized that, like with all medications, the FDA continuously monitors post-marketing safety data for mifepristone, which is used for medical termination of early pregnancy.
He also highlighted that the review would involve collaboration with the FDA’s professional career scientists who analyze the drug’s safety data.
This announcement follows an earlier directive from U.S. Secretary of Health and Human Services Robert Kennedy Jr., who last month instructed Makary to perform a comprehensive review of the abortion pill after a report revealed concerning side effects linked to its use.
New Study Reveals Significant Adverse Effects
The report, published on April 28 by the Ethics and Public Policy Center, analyzed public health insurance records and found that approximately 11% of women experienced serious adverse events within 45 days of taking mifepristone.
The study reviewed 865,727 patients between 2017 and 2023 and found that over 4.7% required emergency room visits related to the abortion, more than 3.3% experienced hemorrhaging, and 1.3% suffered infections.
Thousands were hospitalized, over 1,000 needed blood transfusions, and hundreds faced sepsis, with nearly 2,000 encountering life-threatening complications.
Advocacy Groups Respond to FDA Review Announcement
Kristan Hawkins, president of Students for Life of America and Students for Life Action, welcomed the FDA’s review announcement, urging the reinstatement of safety protocols and removal of the drug from the market to protect women’s health.
Susan B. Anthony Pro-Life America’s Director of Legal Affairs, Katie Glenn Daniel, praised Senator Hawley for his leadership in securing the FDA’s commitment to reexamine abortion drug safety under new agency leadership.
Daniel highlighted a recent peer-reviewed study from the Charlotte Lozier Institute, which challenged claims that medication abortion is safer than common over-the-counter drugs like Tylenol.
She stressed that evidence increasingly shows abortion drugs carry more risks than the abortion industry admits.
Reports of Fatal Complications Highlight Risks
The Charlotte Lozier Institute’s peer-reviewed article published in the journal BioTech disputed the widespread claim that abortion pills are safer than Tylenol.
There have been media reports of at least three women dying in recent years following drug-induced abortions.
One tragic case involved Amber Thurman, a 28-year-old woman from Georgia who died in 2022 from an infection caused by retained fetal tissue after taking abortion pills.
Despite her emergency room visit, doctors failed to promptly perform surgery, leading to her death.
While some blamed state abortion laws, pro-life medical experts cited abortion pill side effects and medical malpractice as primary factors.
How Chemical Abortions Work and Their Prevalence
Chemical abortions use a two-pill regimen.
The first pill, mifepristone, blocks progesterone, a hormone essential for sustaining pregnancy, effectively starving the unborn child of oxygen and nutrients.
The second pill, misoprostol, is taken 24 to 48 hours later to induce uterine contractions and expel the fetus.
Chemical abortions account for roughly half of all abortions in the United States annually.
Progesterone can reverse the effects of mifepristone if administered shortly after the first pill.
Calls for Greater Safety Measures and Regulation
Live Action, a pro-life advocacy group, emphasized that mifepristone starves unborn babies and causes complications in about 11% of women who use it.
They questioned how the drug remains on the market despite these risks.
As the FDA review moves forward, the decision could impact regulations around the abortion pill and potentially lead to changes in how it is dispensed and monitored.
The review underscores growing scrutiny over abortion drug safety amid increasing reports of adverse effects and fatalities.
