4 Myths About the Abortion Pill Mifepristone, Debunked

A recent lightning rod for abortion opponents, the drug mifepristone—the first of two in the standard medication abortion regimen—surfaced several times during Robert F. Kennedy Jr.’s first Senate confirmation hearing as President Trump’s pick for Health and Human Services Secretary. The question of whether Kennedy, if confirmed, will seek to curb access to it or at least raise the scrutiny around it looms large, given recent (unsuccessful) legal efforts by anti-abortion advocates to reverse its FDA approval. (To be clear, that would have a catastrophic impact on abortion access writ large, as medication accounts for more than 60% of US abortions, according to 2023 data from the Guttmacher Institute.)

In questioning Kennedy, both Montana Rep. Senator Steve Daines and Oklahoma Rep. Senator James Lankford brought up often-cited concerns among anti-abortion advocates about the safety of mifepristone and criticized its widespread accessibility. Kennedy’s response was simply that he’d implement whatever policies around the drug Trump decides are best, noting that the president “hasn’t taken a stand on how to regulate it” yet and has asked him to “study the safety” of the drug in order to do so.

But make no mistake: Mifepristone has been thoroughly studied over several decades and the results of that research clearly demonstrate its safety and efficacy for folks who want to end a pregnancy in the first trimester. Read on to learn more about the claims that suggest otherwise—and why you shouldn’t believe these myths.

First, let’s break down how we ended up here.

The FDA approved mifepristone for medication abortion in September 2000, but people who were prescribed the drug could only get it by going to an authorized clinic, medical office, or hospital, thanks to an “in-person dispensing requirement.” (Remember this part—it will come up a lot.) The FDA first eased some of its restrictions on the drug in 2016, which included expanding the gestational age limit to end a pregnancy from seven weeks to 10.

In April 2021, the FDA officially stopped enforcing the in-person dispensing requirement while COVID-19 remained a public health emergency—meaning, people who were prescribed mifepristone could use mail-order pharmacies to get it, a major win because a lot of reproductive health clinics had temporarily shuttered, leaving people who needed abortion care with few options. Removing the in-person dispensing requirement became official later that year, with the caveat that pharmacies needed to be certified to offer the medication.

Then Roe v. Wade, the landmark case that guaranteed the right to an abortion, was overturned in June 2022. Several states have since imposed tight restrictions on abortion care access, some have banned it completely, and others have become safe havens (including via telemedicine) for people who need this form of health care.

Though Conservative judges and lawmakers have claimed that Roe’s reversal would just “send abortion back to the states,” a case challenging access to mifepristone reached the Supreme Court in March 2024. (The lawsuit was filed by a group of anti-abortion doctors who relied on retracted research for the basis of it; they claimed that the FDA failed to account for all the potential dangers of the drug when approving and expanding access to it.) Ultimately, the court dismissed the case, citing a lack of legal standing—in other words, the plaintiffs weren’t experiencing any real harm from the FDA’s actions, so they couldn’t sue. But just this month, a Texas federal judge ruled that three states (Missouri, Idaho, and Kansas) can pick the lawsuit back up in a lower court. (Loosened FDA regulations on the drug, they claim, undermine their state laws that heavily restrict abortion access.)

Should the reupped case make headway, it threatens once again to limit mifepristone access nationwide. And so long as its fate hangs in the balance, and both Trump and Kennedy hesitate to take a stance, misconceptions about the drug will continue to circulate.

Myth #1: The FDA rushed the decision to make mifepristone more accessible.

Mifepristone has been FDA-approved for more than 20 years, and that approval is based on decades of robust, peer-reviewed medical data. Clinical trials began in 1983, and the FDA continues to conduct periodic reviews of data on mifepristone use for medication abortion—no new safety concerns have come to light.

“The abortion pill remains unnecessarily over-regulated,” Ashley Jeanlus, MD, ob-gyn and assistant professor at the University of California, San Francisco’s Bixby Center for Global Reproductive Health, tells SELF. She says the initial label changes made by the FDA in 2016, including the increase of the gestational age limit to 10 weeks, were “consistent with medical evidence.”

And the agency’s decision to ease in-person dispensing restrictions during the height of the pandemic was fueled by the advocacy of top medical organizations: The American College of Obstetricians and Gynecologists (ACOG), with support from the Society for Maternal–Fetal Medicine, legally challenged the FDA to stop enforcing its in-person dispensing requirement so that people who needed abortion care did not have to risk “avoidable COVID exposure to themselves and their clinicians.”

More broadly, reproductive health specialists have long argued that an in-person requirement prevents patients from accessing the medication during early pregnancy loss and disproportionately impacts marginalized communities, including people of color and folks living in health care deserts. Not to mention, research suggests there is no safety or efficacy benefit to getting the drug prescribed by a doctor in person (with testing, like an ultrasound) versus receiving it in the mail without any prior testing.

All to say, the updates to mifepristone access weren’t just a quick check of a box—they reflected careful (and necessary) consideration of ongoing safety data and the overarching consensus of the medical community.

Myth #2: Mifepristone is seriously unsafe.

As noted above, a large body of research has found repeatedly that mifepristone is indeed safe (including when it’s prescribed via telehealth). Verda J. Hicks, MD, the president of ACOG, shared a statement following last year’s Supreme Court case on mifepristone—and she didn’t mince words: “Decades of data have consistently demonstrated that mifepristone is safe and effective for both medication abortion and management of early pregnancy loss. In fact, over time, additional clinical study of mifepristone has led to an improved regimen with an even better safety and efficacy profile,” she said. “The supposed harms of mifepristone have not been substantiated or have been intentionally misrepresented by opponents of abortion in an effort to limit access to a safe and effective drug.”

The statement also pointed out that the case was based on bogus research, and that “the overwhelming majority” of mifepristone’s potential side effects—like bleeding, cramps, and pelvic pain—are “easily treatable or require no additional intervention at all.”

To be transparent, the FDA has received 32 reports of deaths associated with mifepristone since the drug was first approved more than two decades ago. But the medication itself was not attributed as the cause of these deaths; the use of other drugs and medical treatments, coexisting conditions, and gaps in understanding patients’ health statuses were all variables that could have played a role.

“We know that this medication is extremely safe,” Ushma Upadhyay, PhD, MPH, a researcher and core faculty member at Advancing New Standards in Reproductive Health, tells SELF.

Myth #3: The FDA prevents doctors and patients from reporting bad side effects of the drug.

In his hearing, Kennedy’s response to one of the questions he fielded on mifepristone seemed to suggest that people were restricted from reporting a negative side effect of mifepristone by the FDA. He said, “It’s immoral to have a policy where patients are not allowed to report adverse events or doctors are discouraged from doing that.”

But there’s no such policy in place. What he was likely referencing is the FDA’s decision in 2016 to remove the requirement for health care providers to report any adverse event of mifepristone and just mandate them to report deaths. (For context, that means mifepristone started to be treated like most other drugs—for which there is no legal obligation for doctors to report all side effects—instead of being more heavily scrutinized.) But in no way does this shift in regulation limit anyone’s ability to voluntarily report negative effects of the drug—which you or your doctor can do via the FDA’s MedWatch program.

Myth #4: Mifepristone complications send a lot of people to the hospital.

An oft-cited statistic reupped again in Kennedy’s confirmation hearing: 3 to 5% of people who take mifepristone will visit the emergency room (rounded up from the FDA’s prescribing label for the drug, which puts it at 2.9 to 4.6%). But that wrongly implies a high potential for serious side effects—when in reality, a study of nearly 55,000 abortions found that major complications occur in only 0.31% of medication abortions.

So why might people go to the hospital after they take abortion pills? “Many people go through the medication abortion by themselves, and they don’t know whether the amount of bleeding they’re experiencing is normal,” says Dr. Upadhyay, who conducted the above study. “But bleeding is part of the process—these medications cause cramping and bleeding so the contents of the uterus are expelled.” (Mifepristone blocks a hormone called progesterone, which the body needs to continue a pregnancy. The second drug in the regimen, misoprostol, causes the cervix to soften and dilate to help the body expel the pregnancy.)

Some people may also go to the hospital for reassurance that the abortion was effective, she says. That’s because a pregnancy test “won’t give accurate results for four to five weeks after the abortion,” thanks to lingering hormones in the body, Dr. Upadhyay says.

And if you live in an area where there aren’t a ton of clinics, the closest major hospital might be your only option to see a doctor. Hospital visits associated with mifepristone don’t boil down to an inherent lack of safety—which all comes back to stigma: “The reality is people need more information and support when it comes to self-managing their care,” Nancy Cárdenas Peña, campaign director of the Abortion On Our Own Terms campaign, tells SELF. “With accurate information, people can safely self-manage their abortions completely at home.”

Related:

• The Extraordinary Abortion Care I Received Should Be Ordinary
• Experts Say Abortion Bans May Have Devastating Effects on Miscarriage Care
• How to Make an Abortion Emergency Plan Right Now

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