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What the FDA Hasn’t Told You About Mifepristone

The FDA illegally approved chemical abortion drugs with dangerous and life-threatening side effects.
Erik Baptist
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The FDA illegally approved chemical abortion drugs with dangerous and life-threatening side effects

More than two decades ago, the U.S. Food and Drug Administration approved dangerous chemical abortion drugs for use by women and girls.

Even though the FDA failed to study the safety of the drug regimen used in chemical abortions and ignored evidence that chemical abortions cause even more complications than surgical ones, it has never reversed course.

In fact, the FDA has only doubled down on its approval and made it even more dangerous to take these drugs in recent years.

Everyone should know the shocking story of how the FDA recklessly approved these drugs and understand the risks they present to women and girls today.

What are mifepristone and misoprostol?

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

The FDA approved these drugs illegally because it failed to evaluate the risks to minors even though it approved the drugs’ use for young girls. It also misused its authority to expedite approval of these two drugs.

Here’s how the drug regimen works: 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 chemical abortion drugs for women whose babies were at seven weeks’ gestation or less. But in 2016, the FDA extended the use for up to 10 weeks’ gestation.

While the FDA says this drug regimen is safe, the truth is that it can cause much more than just the typical side effects of prescription drugs, and indeed the known complications of chemical abortion drugs are significant and dangerous.

Sadly, the FDA has ignored this fact and spent the last few years removing the few remaining safeguards for these drugs.

The history of chemical abortion drugs

A French pharmaceutical company called Roussel Uclaf S.A. was the first to develop mifepristone, commonly known then as “RU-486.” The drug was widely available in France by 1990, but Roussel Uclaf’s German parent company, Hoechst AG, prevented the drug manufacturer from bringing it to the United States.

That changed between 1993 and 1994. President Bill Clinton’s administration started to pressure Roussel Uclaf to make mifepristone available in America. Eventually, the drug manufacturer “donated” for free the U.S. patent rights for mifepristone to the Population Council, an organization dedicated to fighting “world overpopulation.”

The Population Council filed a drug application with the FDA in 1996, and it took just six months for the Clinton FDA to give initial approval for mifepristone. The FDA did request more information from the Population Council, but by 2000, the agency had approved the two-drug abortion regimen using mifepristone and misoprostol with minimal protections.

Exploiting its fast-track approval authority, the FDA approved these drugs by classifying pregnancy as an “illness” and arguing that the drugs provide a “meaningful therapeutic benefit.” To add to this problem, the FDA did not have any evidence or studies on the potential harms of the drug regimen before approving it.

But instead of admitting its errors, the FDA has only made things worse.

Alliance Defending Freedom’s clients first submitted a petition challenging the FDA’s approval of these chemical abortion drugs in 2002. After 14 years, the FDA finally denied the petition in 2016.

On the same day, the FDA extended the use of chemical abortion drugs from 7 weeks’ gestation up to 10 weeks’ gestation.

It also eliminated additional safeguards in three significant ways:

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

That means that unless a patient dies, abortionists do not have to report the complications and side effects these dangerous 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.

In 2021, the FDA removed the requirement for women seeking chemical abortion drugs to have 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, the FDA made this change permanent.

In a first-of-its-kind lawsuit, ADF is challenging the FDA’s unlawful approval of these chemical abortion drugs and its subsequent elimination of many safeguards intended to protect women and girls.

You can read more about that lawsuit here.

The complications of chemical abortion drugs

Women who have taken chemical abortion drugs have experienced a myriad of complications. In fact, as many as 20 percent of women who have a chemical abortion will suffer a complication.

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 side effects from chemical abortion drugs is bleeding. Many women experience significant pain and bleeding during the initial hours after completing the drug regimen. But women can expect the bleeding to continue for about two weeks after taking the chemical abortion drugs. And 8 percent of women will bleed for longer than a month.

For some women, however, the bleeding can be severe. In fact, one review of 42,000 first-trimester chemical abortions found that more than 1 in 6 women suffered from severe bleeding after taking these drugs.

Another review of 18,000 chemical abortions found that nearly 8 percent of first-trimester chemical abortions failed to kill the baby—meaning that a woman would need surgery if she wanted to complete the abortion.

And, as ADF’s clients have seen firsthand, an alarming number of women end up in the emergency rooms across the country after taking chemical abortion drugs. One study found that more than 35 percent of women who had a chemical abortion visited the ER within 30 days after taking these drugs.

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.

Chemical abortion vs. surgical abortion

No abortion is safe. But research has shown that chemical abortions have an even higher likelihood of complications for women and girls than surgical abortions.

One 2009 study found that women who underwent chemical abortions were about four times more likely to suffer adverse effects. Hemorrhage and incomplete abortions were both significantly higher in chemical abortions than surgical abortions, and six percent of women who attempted chemical abortions needed surgery to complete them.

The FDA and its friends in the abortion industry often claim that mifepristone and misoprostol have “safely terminated” 99.6 percent of pregnancies. Even if that number were true, that means about one in every 250 women who take chemical abortion drugs experience major side effects.

Given that these complications can be life-threatening, that is a significant number of women to put at risk.

Furthermore, the claim that 99.6 percent of women who take chemical abortion drugs within the first 10 weeks “safely terminate” their pregnancies is dubious at best.

Planned Parenthood’s own website says chemical abortion is only 91-93 percent effective for women who are 9-10 weeks pregnant and 87 percent effective for women who are 10-11 weeks pregnant.

This means that 7-13 percent of women who take chemical abortion pills in this timeframe are at risk of health complications, likely requiring surgical intervention and follow-up medical care.

In an interview with “PBS NewsHour,” Whole Woman’s Health CEO Amy Hagstrom Miller said that if ADF is successful in challenging the FDA’s approval of mifepristone, abortion clinics will then advocate for women to use only misoprostol for abortion.

Studies have shown that this drug has a failure rate ranging from 24 percent to 39 percent, meaning that as many as 2 in 5 women would likely suffer complications requiring the need for surgery and additional medical intervention.

Hagstrom Miller tried to blame ADF for these side effects, but the truth is that ADF advocates against all chemical abortion drugs, including both mifepristone and misoprostol. Both drugs can cause life-threatening health concerns for women and girls.

The inescapable conclusion: chemical abortion drugs are dangerous

The FDA should never have approved these chemical abortion drugs. Mifepristone and misoprostol both have dangerous, potentially life-threatening consequences, and the FDA failed to properly study these risks.

Instead of correcting its wrongs, the FDA has only made this drug regimen more dangerous and taken away important safeguards. ADF will continue to fight to protect women and girls by challenging the approval of these harmful drugs.

Portrait of Erik Baptist
Erik Baptist
Senior Counsel
Erik Baptist serves as senior counsel at Alliance Defending Freedom, focusing on administrative litigation and regulatory advocacy.