Scrutinizing the warning label

Earlier this month, attorneys general from New York, California, Massachusetts, and New Jersey filed a petition asking the U.S. Food and Drug Administration to remove what they called “outdated” and “unnecessary” restrictions on the abortion drug mifepristone. They argued the agency should no longer subject the pills to the Risk Evaluation and Mitigation Strategy it reserves for dangerous drugs.

Under the policy, prescribers of mifepristone must appear on national and local abortion provider lists, pharmacies must get certification to carry the drug, and patients must sign agreement forms confirming their intent to kill their unborn child. But the attorneys general argue the regulations “impede access” to mifepristone and dissuade physicians from prescribing the drug. “Given mifepristone’s 25-year safety record, there is simply no scientific or medical reason to subject it to such extraordinary restrictions,” said New York Attorney General Letitia James.

The Democrat-led states submitted their complaint after Health and Human Services Secretary Robert F. Kennedy Jr. said he would direct the FDA to review the drug’s safety in light of recent data. Earlier this month, FDA Commissioner Marty Makary agreed to conduct a full review of mifepristone. While abortion advocates have long claimed mifepristone is safe for women and rarely has adverse effects, a new data analysis backs up researchers’ warnings that the pill is far more dangerous than its supporters admit.

In 2000, the FDA approved mifepristone for use alongside misoprostol to perform abortions after 10 clinical trials appeared to show the drug was safe for women. Out of more than 30,000 patients, the trials found that serious adverse events occurred in fewer than 0.5% of women who took the abortion regimen. Since then, more than 7.5 million women in the United States have taken mifepristone in an abortion, and the pills now account for more than 60% of all abortions.

But since that initial approval, the dispensing requirements for the drug have changed dramatically. When it first became available, the FDA only permitted certified medical professionals during in-person visits to prescribe mifepristone to women who were up to seven weeks pregnant. The agency required patients to have three in-office visits—one to determine the gestational age of their unborn child and to rule out ectopic pregnancy, another to take the pill, and a follow-up appointment to check for complications. It also required abortionists to report any adverse effects to the FDA, as is standard practice with many drugs and vaccines.

In 2016, during the final year of the Obama administration, the FDA relaxed its guidelines by requiring only two in-office visits with a medical professional and allowing women to take mifepristone up to 10 weeks of pregnancy. It further reduced protections in 2021 by completely removing the requirement to attend any in-person visits with a medical professional. In 2023, the Biden administration also allowed retail pharmacies to dispense mifepristone directly to patients.

Three states—Missouri, Kansas, and Idaho—have challenged that removal of protections in an ongoing lawsuit. In January, a federal judge ruled that the states have standing to pursue the legal challenge, an important step after the U.S. Supreme Court unanimously ruled last year that the pro-life doctors who first brought the suit did not have standing.

As officials gradually chipped away regulations surrounding the drug, Ryan Anderson, president of the Ethics and Public Policy Center, said he and other pro-life advocates became increasingly concerned that the current warning label for the pill was no longer accurate. “We had been hearing stories from pro-life doctors in the ER and OB-GYNs saying the abortion pill is much more dangerous to women,” he said. “We know that when the abortion pill works, it’s deadly for children, but the concern here is that it’s also much more dangerous for women than the FDA has ever admitted.”

In April, Anderson and Jamie Bryan Hall, the center’s director of data analysis, published an analysis of data from an all-payer insurance claims database. The data, which they obtained from both private and public insurers, includes 865,727 mifepristone abortions prescribed to 692,873 women from 2017 to 2023. According to their analysis, 10.93% of women experienced a serious adverse event within 45 days of taking the drug.

The team of medical doctors reviewing the data excluded emergency room visits that were unrelated to the abortion attempt or that they determined were not serious, Anderson said. Though the insurance providers made the claims information anonymous, Anderson said the researchers were careful to count each pregnancy only once, even if a woman experienced more than one adverse event.

The team only included instances when the woman required significant medical intervention. Nearly half of the 94,605 instances of an adverse event connected to mifepristone resulted in a woman visiting the emergency room. Across all of the prescribed abortions that resulted in a serious adverse event, 1.34% were connected to infections, 2.84% ended in a surgical abortion, and 3.31% resulted in hemorrhage, which insurance codes differently than typical levels of abortion-related bleeding. Another 5.68% resulted in other abortion-related complications, including damage to a woman’s internal organs from the abortion or life-threatening mental health diagnoses that occurred later.

Though the report did not involve any clinical trials, Anderson said the analysis gives a clear picture of how mifepristone affects women. “Real world insurance data shows you how this drug is being used in reality, not under ideal circumstances,” he said.

The stories of two Georgia women who died in 2022 gained national attention after abortion advocates claimed their deaths were related to the state’s pro-life laws. Pro-life doctors clarified that both women experienced complications after taking abortion drugs.

Pro-abortion groups, including the American College of Obstetricians and Gynecologists, have claimed Anderson and Hall manipulated the data to support their position. The drugmaker Danco says cramping and bleeding are known side effects, and abortion advocates say there have not been any new studies to show the drug is not safe. An FDA investigation into the deaths of 36 patients who took mifepristone between 2000 and 2024 found their deaths could not be conclusively attributed to the drug.

But Anderson said he believes their findings will hold up to scrutiny and called on federal officials to do their own review. “This should make the FDA think twice about whether the current regime of mail order telehealth is really in the best interests of the safety and the protection of these women,” he said.

Dr. Donna Harrison, director of research at the American Association of Pro-Life Obstetricians and Gynecologists, said that abortionists dispensing mifepristone without listing real-world complications could amount to medical malpractice. “Women are … actually not able to give informed consent,” she said.

Because women do not have to receive an ultrasound before being prescribed mifepristone, Harrison said the chances of a patient taking the drug farther along in her pregnancy or experiencing an ectopic pregnancy are much higher. “You can’t tell a woman what her rate of complications will be unless you know exactly how far along she is in her pregnancy,” she said.

The warning label on the name brand version of the drug specifically indicates that women who are more than 10 weeks pregnant, have an ectopic pregnancy, or have other preexisting conditions should not take mifepristone.

Regardless of clear risks, abortion advocates maintain that it is safe. Planned Parenthood has long claimed the regimen is safer than the anti-inflammatory medication Tylenol, though no study has compared the two drugs and such a study would not be valid, since the drugs have very different purposes.

In a May 24 peer-reviewed article, the pro-life Charlotte Lozier Institute disputed the claim as unfounded and misleading. Abortion supporters often point to Tylenol-related deaths as evidence of its risks, but those deaths typically result from misuse across a much larger number of users. Meanwhile, even women who take mifepristone as prescribed face heightened risks.

While Harrison and Anderson advocate for pulling the pill from the market entirely, both recognize that convincing federal officials to do so is unlikely. At the very least, they say that the FDA should reinstate the regulations it put in place in 2000. “It’s not real medical care. What it is is an attempt at a chemical solution to a social problem … that involves actually killing the human being in the womb,” Harrison said.

Other pro-life doctors agree that the study should push regulators to hold mifepristone up to the same scrutiny as other medications. Dr. Eric Hussar pointed to the FDA’s decision in 2020 to pull the acid-blocking drug Zantac from the market over concerns the medication could contain elevated levels of a carcinogen.

“Essentially they said, ‘We’re pulling this off the shelves because of the possibility that it might hurt someone, even though we don’t have real data to show that it does,’” said Hussar, who is the Pennsylvania state director for the American Academy of Medical Ethics.

Hussar said it is critical that patients know the truth about the risks of any medication they take. But while mifepristone poses significant risks to women, mifepristone is almost always fatal for unborn babies. “If the solution to that is just finding a quote, unquote, safer abortion pill, then we’ve also still neglected the baby in the process,” he said. “It’s the enemy that’s behind it all … and he’s going to do whatever he can to try to destroy life.”