What the FDA Hasn’t Told You About Mifepristone

When the U.S. Food and Drug Administration approved the high-risk abortion drugs mifepristone and misoprostol for use by women and girls, the agency included crucial safety standards it deemed necessary when using these drugs. Since then, the FDA has increased the risks to women by removing these important safety standards.

Because of the FDA’s lawless decision to recklessly remove these safety standards, more women have suffered severe and even life-threatening consequences. Now, it’s time for the agency to prioritize women’s health and safety by reinstating the critical safety standards it has abandoned.

ADF is challenging the agency’s reckless and illegal actions in court, and the U.S. Supreme Court has agreed to hear the case. (You can read more about that lawsuit here.)

But just what are these drugs? What makes them high-risk? And how has the FDA eroded their safety standards?

Mifepristone and misoprostol

In 2000, the FDA approved two drugs that are used together to complete a chemical abortion—mifepristone and misoprostol.

Here’s how the drugs work: first, mifepristone kills the unborn child by cutting off the supply of necessary hormones to the uterus so that it can no longer support life.

Second, between 24 and 48 hours after taking mifepristone, a woman is instructed to take misoprostol to induce labor and delivery of her baby.

Originally, the FDA only approved the use of these abortion drugs for women whose babies were at seven weeks’ gestation or less. But in 2016, the FDA extended the use to up to 10 weeks’ gestation.

These drugs can cause significant and serious complications. Unfortunately, the FDA has ignored this fact and spent the last few years removing the few remaining safety standards for these drugs.

How has the FDA disregarded women and girls’ health?

In 2016, the FDA didn’t just extend the use of abortion drugs; it also eliminated safeguards in three significant ways:

• by reducing the number of required office visits for women taking abortion drugs from three to one
• by no longer requiring that a doctor prescribe the drugs
• by eliminating the requirement that prescribers report non-lethal adverse events from the drugs

That means that unless a patient dies, abortion providers do not have to report the serious complications these high-risk drugs can cause, further obscuring the truth about their safety. And emergency room doctors are under no obligation to report these adverse events, nor are they often aware that they can even submit such reports, let alone have the time to do so.

In 2021, the FDA went even further and removed the requirement for women seeking abortion drugs to have any in-person appointments.

This meant that doctors could prescribe the drugs via telehealth appointments—without the ability to perform an in-person examination or an ultrasound to confirm the baby’s gestational age or to identify life-threatening ectopic pregnancies.

The FDA said this was a temporary change due to the COVID-19 pandemic. But by the end of that year, it made the change permanent.

By removing many important safety standards for abortion drugs, the FDA has demonstrated a callous disregard for the health and safety of women and girls.

The FDA’s lawless actions have caused women and girls to suffer

Women who have taken abortion drugs have experienced a myriad of complications. Some of these complications have been serious and even life-threatening, which makes the FDA’s insistence that these drugs are safe even more dubious.

One of the most common complications from abortion drugs is bleeding. Many women experience significant pain and bleeding during the initial hours after taking mifepristone and misoprostol. But women can expect the bleeding to continue for about two weeks after taking the abortion drugs. And 8 percent of women will bleed for longer than a month.

And, as ADF’s clients have seen firsthand, an alarming number of women end up in emergency rooms across the country after taking abortion drugs. The FDA’s own label for these drugs says that roughly one in 25 women who take them will end up in the emergency room, and research has suggested the number could be even higher.

The American College of Obstetricians and Gynecologists (ACOG) has identified low hemoglobin; severe liver, renal, or respiratory disease; uncontrolled hypertension; and cardiovascular disease as conditions that can cause abortion drugs to be particularly high-risk. Since the FDA removed the requirement for women to visit a doctor in person before taking abortion drugs, doctors may not be able to properly diagnose these conditions before prescribing mifepristone and misoprostol.

Even for women without any of these conditions, abortion drugs are risky. Serious complications reported to the FDA in connection to the drugs include ruptured ectopic pregnancies resulting in death, sepsis that has resulted in death, and significant blood loss that has required blood transfusions.

The FDA must protect women and girls

For 16 years, the FDA maintained critical safety standards for abortion drugs. But in 2016, it suddenly abandoned its duty to women and girls by removing these safeguards without sufficiently evaluating the effect it would have on women’s health.

Women taking high-risk abortion drugs should have the ongoing care of a doctor. But thanks to the FDA, women and girls end up taking these drugs all alone in their homes or dorm rooms, often unaware of what they will experience or when emergency care is necessary.

Our clients have witnessed the effects of the FDA’s reckless decisions firsthand. They have treated significantly more women suffering injuries and complications from taking these drugs alone, unsupervised, and without ever having seen a medical professional.

The FDA has a duty to prioritize people’s health and safety, which is why it must restore the critical safety standards for abortion drugs.