The future of the most common method for ending pregnancies hangs in the balance as legal arguments play out (pdf) over whether the U.S. Food and Drug Administration (FDA) ignored safety concerns when it approved mifepristone more than two decades ago and exceeded its authority by loosening safeguards with subsequent amendments.
Mifepristone, or “Mifeprex,” is a synthetic steroid that blocks progesterone, a hormone needed for a pregnancy to develop. It is combined with a second drug, misoprostol (marketed as Cytotek)—to end intrauterine pregnancy through 10 weeks of gestation.
Some argue drugs that induce medical abortions are as safe as low-risk prescription drugs such as penicillin and Viagra—and should be available over-the-counter. Others argue the drug was never proven safe, and women face severe complications from its use, requiring them to obtain medical care or undergo a complete abortion.
“Mifepristone is a potentially dangerous drug and should not be used indiscriminately, nor should it be used as an over-the-counter abortifacient,” Dr. James Thorp, a maternal-fetal medicine specialist, told The Epoch Times in an email. “Mifepristone is brutal in termination, whether used for an elective abortion or a missed abortion, and it is extremely painful.”
Abortion Pill Side Effects and Complications
A 2021 study published in Cureus found that most pregnant women who took mifepristone and misoprostol to terminate their pregnancies without medical consultation experienced severe complications.
Severe complications reported (out of 100 cases):
- Excessive bleeding (78 percent).
- Incomplete abortion (66 percent).
- Missed abortion (6 percent).
- Unaffected pregnancy (6 percent).
- Ectopic pregnancy requiring surgical intervention (12 percent).
- Anemia in half of the cases, with 44 percent requiring a blood transfusion.
A 2015 study published in the Journal of Clinical and Diagnostic Research examining self-administered abortion pills found similar results and concluded that unsupervised medical abortions could lead to increased maternal morbidity and mortality.
Among 40 patients, 27 percent used abortion pills after the approved period, 77 percent experienced excessive bleeding, and 62 percent had an incomplete abortion—including 7 percent experiencing sepsis, a life-threatening medical emergency. Surgical intervention was needed for 67 percent of patients, with 12 percent requiring a blood transfusion.
According to a paper published in StatPearls and updated in May 2022, significant adverse reactions to mifepristone include bacterial infections and prolonged, heavy menstrual bleeding, fetal death, anaphylactic reactions, toxic epidermal necrolysis (a potentially life-threatening skin condition), angioedema, and teratogenesis.
Moderate reactions include low potassium, peripheral edema, high blood pressure, dyspnea (difficulty breathing), constipation, hypoglycemia, vaginal bleeding, stomatitis (inflammation of the mouth and lips), hot flashes, endometrial hyperplasia, anemia, low cortisol, heart palpations, and low blood pressure.
Mild reactions associated with mifepristone include nausea, abdominal pain, fever, vomiting, fatigue, headache, diarrhea, dizziness, sinusitis, pharyngitis, gastroesophageal reflux disease, malaise, insomnia, maculopapular rash, pruritus (itchy skin), pelvic pain, chills, menstrual irregularity, emotional lability, and syncope (fainting).
FDA Relaxed Requirements Despite Safety Concerns
According to the court documents challenging the FDA’s approval of regulatory standards for mifepristone, the Population Council, a non-profit entity with patent rights to mifepristone, asked the FDA in 1996 to approve the drug as part of a two-drug regimen designed to cause abortion. (pdf)
First, a pregnant woman takes mifepristone, suppressing the production of progesterone required to maintain the uterine lining and provide nutrients to the baby. After taking mifepristone, the patient takes misoprostol, which causes uterine cramps and expels any contents of the uterus.
As part of the new drug application, the Population Council relied on only three clinical studies—one from the United States and two from France. The studies claimed mifepristone was effective in most cases under the conditions imposed in each study.
Conditions required women to undergo an ultrasound to verify gestational age and to rule out potentially life-threatening ectopic pregnancies, prescribing physicians needed to have surgical abortion experience with admitting privileges at a nearby hospital, testing facilities needed to be located near hospitals, and women were to be monitored during four-hour window after taking the second drug, misoprostol.
Although mifepristone was reportedly effective for most patients, the studies showed that some women experienced serious adverse events requiring surgical intervention for heavy bleeding, infection, and incomplete abortion.
Despite these concerns, the FDA in 2000 approved mifepristone under the brand name Mifeprex for termination of pregnancy with a black-box warning that provided “restrictions to assure safe use.” The regimen required at least three visits to a healthcare provider over several days and was only labeled for use through 49 days of gestation.
A group of obstetrician-gynecologists, along with several organizations, in 2002 filed a citizen’s petition (pdf) and asked the agency to revoke mifepristone approval, arguing it was unsafe under the approved conditions.
The FDA reviewed the petition over the next 14 years, ultimately denying it in 2016, and instead relaxed safeguards for the product, the court documents state. (pdf) The FDA increased the maximum gestational age from 49 to 70 days, allowed non-physicians to prescribe mifepristone, removed the requirement that the administration of misoprostol include a follow-up appointment in person, changed the dosage of each drug used, and eliminated the requirement that prescribers report non-fatal events.
In 2019, the agency approved an “abbreviated new drug application” by GenBioPro, Inc. for a generic version of mifepristone. To assess whether the drug was safe, the agency used the same data relied upon for the 2000 approval and 2016 amendments regarding mifepristone.
In 2021, the FDA said it would no longer enforce the in-person dispensing requirement due to the COVID-19 pandemic—allowing mifepristone to be prescribed remotely and delivered by mail. Later that year, the FDA made the change permanent, resulting in a lawsuit poised to go to the U.S. Supreme Court. The agency claims the requirement was “no longer necessary to ensure that the benefits of the drug outweigh the risks.” (pdf)
Although drugs that induce medical abortions aren’t currently available over-the-counter, a woman can obtain these drugs in several states through the mail without an in-person clinic visit in states where abortion is legal.
According to statements made to Politico, the Biden administration and Danco Laboratories—the distributor of mifepristone—are defending how the FDA regulates the drug and claim it has a decades-long safety record. They fear that a win would inspire “copycat lawsuits” targeting other drugs like COVID-19 vaccines and contraceptive pills. Furthermore, they say performing a complete abortion due to a drug’s side effects is part of a physician’s job. The Department of Justice has said it remains committed to defending the FDA’s scientific judgment.
The Epoch Times contacted the FDA for comment and has not yet received a response.