Supreme Court Hears Landmark Abortion Pill Case. How Safe Is the Disputed Drug Mifepristone?

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If it rules in favor of the Alliance of Hippocratic Medicine, pregnant women’s access to mifepristone could be limited.

On Tuesday, the U.S. Supreme Court heard the U.S. Food and Drug Administration (FDA) v. Alliance of Hippocratic Medicine (AHM), a case affecting access to mifepristone, an abortion drug. The ruling is expected in June.

Mifepristone is often said to be safer than Tylenol, and currently, women can access it without medical supervision. This begs the question: How safe is the drug?

How Does Mifepristone Work

The FDA approved mifepristone in 2000. The drug is usually prescribed in conjunction with misoprostol to terminate a pregnancy, though medical abortion can also be achieved with only misoprostol.

In 2023, around 60 percent of abortions in the United States were medical, meaning they were performed with medication, an increase from 53 percent in 2020. The alternative to medical abortion is surgical abortion, which must be performed in a clinic.

Mifepristone is a synthetic hormone that works by blocking the hormone progesterone. The body needs progesterone to maintain a pregnancy.

A patient first takes mifepristone and then misoprostol within 48 hours. Misoprostol causes cramping and bleeding, which abort the fetus from the uterus.

Medical abortion is not recommended for longer gestation periods as it may not fully terminate the pregnancy and can cause excess bleeding.

Is Mifepristone Safe?

Few deaths have been reported with mifepristone. The FDA reported that since the drug’s approval, 5.9 million women have taken the drug, and only 32 have died. However, these deaths were not officially causally linked to mifepristone.

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At the time of approval, mifepristone was only available for women with a gestation period of 49 days, or seven weeks. Women also needed medical supervision, ultrasound to confirm their gestation period and follow-up sessions post-abortion.

However, since 2016, mifepristone has been approved for pregnant women with 70 days gestation period. By 2021, women no longer needed medical supervision and could receive the drug through the mail of a certified prescriber or mail-order pharmacy.

Regarding death from drug use, mifepristone is often said to be safer than Tylenol.

However, there appears to be a greater risk of emergency room visits after taking the drug. Around 3 percent to 5 percent of women undergoing medical abortion will need additional surgeries to terminate the pregnancy or to resolve complications such as excessive bleeding.

A study led by professor Ushma Upadhyay at the University of California–San Francisco comparing abortion complication rates found that medication abortion had an even higher rate of complications of 5.2 percent compared to surgical abortion, though most of which “were minor and expected.”
According to a paper published in StatPearls, severe adverse events of mifepristone include bacterial infections, excessive bleeding, anaphylactic reactions, life-threatening exfoliation of the skin, and swelling.

Moderate reactions may present as peripheral swelling, high or low blood pressure, shortness of breath, low blood sugar, uterine contractions, stomatitis, hot flashes, thickening of the uterine lining, anemia, adrenocortical insufficiency, and palpitations.

The Epoch Times reporter visited major websites offering advice or providing access to mifepristone. Some online pharmacies would sell mifepristone to anyone as long as the user could make the payment.

In their written arguments, doctors of AHM stated that increasing the gestational period increases a woman’s risk of complications when using the drug. Women are at a greater risk of excessive bleeding and having an incomplete abortion as their gestation period increases.

Additionally, medical abortions without medical supervision remove “the best opportunity to diagnose dangerous ectopic pregnancies and accurately assess gestational age.” Medical abortions cannot terminate an ectopic pregnancy, and the symptoms a patient experiences may mask this kind of pregnancy.

Medical abortions can also lead to other severe adverse events.

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.

Seventy-eight percent of women experienced excessive bleeding and 66 percent reported incomplete abortion. Half of the cases also experienced anemia, with 44 percent requiring a blood transfusion.

A 2015 study examining self-administered abortion pills found similar results, concluding that unsupervised medical abortions could lead to increased maternal morbidity and mortality.

Among 40 patients, one-third used abortion pills after the approved period, 77 percent experienced excessive bleeding, and 62 percent had an incomplete abortion. Additionally, 7 percent experienced sepsis, a life-threatening medical emergency.

Surgical intervention was needed for two-thirds of the patients, with 12 percent requiring a blood transfusion.

Women and families who have been harmed by mifepristone also filed a statement to the Supreme Court.

One of the testimonies came from a woman named Leslie Wolbert, who claimed abortion clinics misled her into thinking the medical abortion with mifepristone would be akin to having a “heavy period.”

Some clinics say most women will not experience symptoms from mifepristone. However, Ms. Wolbert said that on the second day, she experienced “the worst pain I’ve ever felt in my life. The experience wasn’t just a heavy period. I was bleeding like I never knew possible.”

The pain was more than she could handle, and she was “begging to die,” she said. The blood and matter from her medical abortion “clogged the drain [of the shower].”

Her testimony was echoed by two other women who reported seeing their baby rather than the clump of tissues they were told to expect. They went on to say that they no longer feel safe in their homes due to the traumatic experience.

Will Access to the Abortion Pill Change After the Ruling?

Some politicians and abortion advocates have exaggerated the effects of the case, claiming it will cause broad restrictions on the drug across all states.

However, women in states where abortion is legal would still be able to get access to medical abortion regardless of the Supreme Court ruling.

“The Supreme Court is not considering a challenge to mifepristone’s initial FDA approval. So if it rules for AHM, mifepristone would go back to pre-2016 restrictions—at least until FDA considered the evidence again and potentially made the same changes to the conditions for access again,” Holly Fernandez Lynch, assistant professor of medical ethics and health policy at the University of Pennsylvania, told The Epoch Times.

In other words, pregnant women over 49 days of gestation may no longer be able to access the drug without medical supervision.

Megan Redshaw contributed to this report.

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