Mifepristone 'safer than Tylenol,' experts say amid court battle over major abortion pill

At the center of a court battle over medication abortion now headed to the Supreme Court is the safety record of the major abortion pill mifepristone.

The plaintiffs in the case, which targets FDA approval of the drug, claim it comes with medical risks and should be pulled from the market.

But leading medical associations and health experts say otherwise, pointing to mifepristone's decades-long safety record and studies showing it to be safer than common drugs such as Tylenol and Viagra. Instead, experts say a ruling in Texas that called for the FDA to halt mifepristone's approval relied on debunked claims that exaggerate the harms of the drug.

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"This medication has been used safely and effectively in the United States by over 5 million pregnant people for the past 23 years and today accounts for more than half of all abortions in the United States," said Ushma Upadhyay, a professor of obstetrics and gynecology at the University of California, San Francisco, who studies contraception and abortion care. "Study after study demonstrates the strong safety rating of over 99%."

"Instead of relying on the mountain of evidence demonstrating safety, the court turned to anecdotes from anti-abortion advocates and blog posts," she added. "That's not how scientific research works."

Last week, the U.S. Supreme Court temporarily paused the lower court's ruling that put limits on access to mifepristone so that justices have more time to review the case. Mifepristone remains available as the case moves through the federal court system.

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Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on March 16, 2022.
Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on March 16, 2022.

Is mifepristone safe?

The U.S. Department of Health and Human Services, the American Medical Association and the American College of Obstetricians and Gynecologists call mifepristone safe and effective for abortion and miscarriage care.

Studies show major adverse reactions to the drug are "exceedingly rare," occurring in about 0.3% of cases, according to the AMA. The risk of patient death from medication abortion is near zero, according to the association.

Mifepristone has been discussed in more than 780 medical reviews and used in more than 630 published clinical trials, the AMA said. It has also long been approved for use in 19 countries. In France and China, mifepristone was approved for abortion care in 1988, years before the FDA approved the drug in 2000.

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Experts: Mifepristone is 'safer than Tylenol,' Viagra

Mifepristone is among "the most studied medications" prescribed in the United States, according to an amicus brief filed in support of the FDA by the AMA, the American College of Obstetricians and Gynecologists, American Academy of Family Physicians and several other organizations. The evidence supporting the drug's safety and efficacy is "overwhelming" and "on par with common painkillers like ibuprofen and acetaminophen," according to the brief.

Demonstrators rally in support of abortion rights at the Supreme Court on April 15, 2023.
Demonstrators rally in support of abortion rights at the Supreme Court on April 15, 2023.

There were five deaths associated with mifepristone for every 1 million people in the United States who've taken the drug since its approval, according to 2022 FDA data.

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Meanwhile, acetaminophen, or Tylenol, is responsible for 56,000 emergency department visits, 2,600 hospitalizations and 500 deaths per year in the United States, according to the National Center for Biotechnology Information. Risk of death by taking Viagra is nearly 10 times greater than that of mifepristone, according to a study cited in an amicus brief filed by the FDA.

"Mifepristone is an incredibly safe and effective medication," said Dr. Gopika Krishna, an OB/GYN in New York and a fellow at Physicians for Reproductive Health. "It's a medication that's safer than Tylenol, safer than medications like Ibuprofen or Viagra...When we see people trying to limit access to this drug, it's not about safety. It's ultimately about limiting access to abortion."

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Contact Christine Fernando at cfernando@usatoday.com or follow her on Twitter at @christinetfern.

This article originally appeared on USA TODAY: Is mifepristone safe? Abortion pill widely backed by medical experts