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Alliance Defending Freedom, the legal group suing the Food and Drug Administration over its 2000 approval of the abortion pill mifepristone, falsely claimed in a video that 1 in 5 women who undergo medication abortion will experience a complication.
The claim appears to be based on a 2009 study that experts said misclassified complications and didn’t use standard definitions of adverse events, researchers said. The study’s lead author said this claim distorts their findings.
The video also ignores more than 100 studies spanning over four decades that have found medication abortion to be a safe and effective way to terminate a pregnancy.
After two judges, one in Texas, the other in Washington, issued dueling rulings on access to the abortion pill mifepristone, it stirred social media discussion about the medication’s safety.
A Facebook video shared in March by Alliance Defending Freedom, the Christian legal group representing anti-abortion groups and doctors in the Texas lawsuit, received renewed attention and thousands of views.
"This case is about protecting women and girls from the dangers of chemical abortion drugs,"Alliance Defending Freedom attorney Erica Steinmiller-Perdomo said in the March 27 video. "The fact is these drugs are dangerous — 1 in 5 women will suffer a complication."
Medication abortion, which involves a combination of two medicines — mifepristone and misoprostol — typically taken around 24 hours apart, accounts for more than half of all U.S. abortions and has been used by more than 5 million women, according to the Guttmacher Institute, an abortion-rights research organization. It has become the only method available to many women living in states where abortion has been banned.
The U.S. Food and Drug Administration has repeatedly reaffirmed mifepristone’s safety since it was first approved in 2000. (Misoprostol has been on the market longer and has different uses, including preventing stomach ulcers).
PolitiFact reached out to Alliance Defending Freedom for evidence supporting its "1 in 5" claim. We did not receive a response by publication. But the alliance’s lawsuit cites a 2009 study from Finland.
We found the same statistic on the website for the anti-abortion Charlotte Lozier Institute, which also cited the Finland-based research. That study evaluated national registries for women in the country who had abortions between 2000 and 2006 and found that about 20% who took medication abortion said they experienced adverse events.
The study’s lead author said the claim distorts her research, and experts told us the research is flawed. The paper didn't use a standardized definition for adverse events. It included cases where women took mifepristone alone or misoprostol with another drug. And it included complications that required no medical intervention.
In a comprehensive analysis of research on the topic, The New York Times showed that more than 100 studies reviewing 124,000 abortions over 30 years have found medication abortion to be safe and effective for women.
"I think (mifepristone) is one of the best studied medications that’s currently on the market," Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, told PolitiFact. "There’s been a lot of research done on this treatment, and study after study shows that medication abortions are very safe and very effective."
On April 7, U.S. District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, ruled in Texas that the FDA lacked the authority to approve mifepristone more than two decades before. The decision would suspend the agency’s approval, which could trigger its removal from the market. Kacsmaryk wrote that his decision would go into effect after seven days, giving the Justice Department time to appeal.
That same day in Washington state, U.S. District Judge Thomas Rice, whom former President Barack Obama appointed, found the opposite in a separate case, and issued an order prohibiting the FDA from pulling access to mifepristone in 17 Democratic-led states that sued over the issue.
The rival rulings add legal confusion to a growing tangle of abortion-litigation across the country following the Supreme Court’s June 24, 2022, decision to overturn Roe v. Wade.
On April 10, the federal government asked the 5th Circuit Court of Appeals to block the Texas order pending its appeal. The court ruled April 12 that mifepristone could remain available, but imposed temporary restrictions that rolled back more recent changes the FDA made to improve access to the drug, including patients getting the pills by mail.
More than 400 drug company leaders — none of which make mifepristone — condemned the Texas ruling in a signed statement that said the decision ignored decades of scientific evidence and legal precedent and called for its reversal.
"If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone," the statement said.
In an April 8 post announcing its appeal of Kacsmaryk’s decision, the FDA said it "stands behind its determination" that mifepristone is safe and effective under its approved conditions of use for medication abortion, and added that patients should have access to FDA-approved medications.
In 2009, researchers in Finland published a paper in the Obstetrics & Gynecology medical journal. The study consulted three of the country’s national health registries for 42,619 women who, from 2000 to 2006, had abortions through their eighth week of pregnancy. The patients were followed until about six weeks following their abortions.
About 22,000 had medication abortions; the other 20,000 underwent surgical abortions. Researchers reported that about 20% of the women who took medication for their abortions experienced what the paper described as adverse events or complications, with hemorrhage making up the lion’s share at 15.6%
But experts said there’s a glaring issue with hemorrhages it classified as "complications." These situations were defined in the study as excessive bleeding that involved clinician consultation, and the paper doesn’t say whether they required medical interventions or blood transfusions.
"We know that bleeding is an expected outcome with medication abortion and people are told about it in advance," Grossman said. "But this study doesn’t have a standardized definition of hemorrhage, and there was no reporting on transfusions."
Maarit Niinimäki, the study’s lead researcher and consultant gynecologist at the University Hospital of Oulu, Finland, also told PolitiFact in an email that the 1-in-5 claim distorts her research.
"We concluded that medical abortion is generally safe and serious adverse events were rare," Niinimäki said. "As this was a register-based study, we reported all visits in the hospital for various indications, many of them were for benign reasons and did not lead to intervention."
Niinimäki also said bleeding is a result of the abortion process and isn’t dangerous in the majority of cases.
"Sometimes a patient comes to a check-up visit if she’s worried. But you can not get detailed information of the visits when having a register-based study," Niinimäki said.
Niinimäki said that when her study was published, medication abortion was a new method in Finland and the routine for follow-up was not well established and likely caused additional visits.
"We are independent researchers aiming to publish the results honestly without (a) political agenda, and we never claimed that medical abortion with mifepristone/misoprostol protocol is a dangerous procedure and should be abandoned," Niinimäki said.
Grossman called the Finland study "very nonspecific" because it’s based on coding that providers entered following their clinical encounters.
Ushma Upadhyay, a professor and public health scientist at University of California, San Francisco and lead author of a 2015 study on emergency department visits and complications after abortion, said the Finland study "is simply not rigorous."
"It didn’t use standard definitions of adverse events, and the most notable weakness is its classification of hemorrhage without additional treatment," Upadhyay wrote in an email.
"The fact that these patients simply consulted with their clinician, but were not deemed to need additional treatments suggests that these were not adverse events," Upadhyay said. "They had bleeding, that is part of the expected effects."
The paper’s authors acknowledged this in their report, writing that "because medical abortion is associated with uterine bleeding lasting approximately 2 weeks, the high rate of consultation is not surprising."
Experts also noted that the study suggested that some women received mifepristone alone, which is known to be associated with increased adverse events, they said.
The more than 100 studies on the abortion pills concluding that the medication regimen is safe found that the rate of major complications requiring treatment, such as severe hemorrhages or infection, is very low.
Upadhyay’s study, which assessed around 11,000 medication abortion cases, found that these types of complications amount to about one-third of a percent.
Upadhyay said that anti-abortion activists have misrepresented her data about emergency department visits to try to support their claims that abortion is unsafe. (Her study is referenced on the same Charlotte Lozier Institute webpage as the Finnish study.)
But these visits do not signal complications, she said, and research has shown that patients who live farther away from where they received an abortion were more likely to go to the emergency room for reassurance or to confirm that the abortion was successful. Another study found that around 51% of abortion-related emergency department visits involve observational care only, with no diagnosis or treatment.
"This really shows that people go to the emergency department to have their questions answered. They aren’t getting any treatment. They are being observed and released," Upadhyay said. "They don’t have a nearby abortion provider for help, so they’re going to go to the closest safety net provider that they can that’s open 24/7."
Mifepristone is considered safer than many common drugs, including Tylenol and Viagra, and when used in the recommended protocol with misoprostol, successfully terminates pregnancy 99.6% of the time, with a 0.4% risk of major complications, the Kaiser Family Foundation reported.
The FDA’s latest data is comparable, with five deaths associated with mifepristone for every 1 million people in the U.S. who have used the drug since its approval in 2000. That’s a mortality rate of 0.0005%.
A video from Alliance Defending Freedom claimed abortion pills are dangerous and that "1 in 5 women will have a complication."
The statistic appears to be based on a flawed study that experts said misclassified complications. The study’s lead author said the claim misconstrues the research. More than 100 studies spanning multiple decades have found that medication abortion is safe and effective.
We rate this claim False.
Facebook, Alliance Defending Freedom video ad, March 27, 2023
Washington Post, Texas judge suspends FDA approval of abortion pill; second judge protects access, April 7, 2023
Associated Press, Judge in Washington orders feds to keep abortion pill access, April 7, 2023
Charlotte Lozier Institute, Fact Sheet: Risks and Complications of Chemical Abortion, July 19, 2022
National Library of Medicine, Immediate Complications After Medical Compared With Surgical Termination of Pregnancy, October 2009
Advancing New Standards in Reproductive Health, Incidence of Emergency Department Visits and Complications After Abortion, January 2015
ABC News, DOJ asks appeals court for emergency stay of abortion pill ruling, April 10, 2023
The New York Times, Court Says Abortion Pill Can Remain Available but Imposes Temporary Restrictions, April 13, 2023
PolitiFact, The top claims about abortion, fact-checked, March 2, 2023
The New York Times, Are Abortion Pills Safe? Here’s the Evidence, April 7, 2023
CNN, How safe is the abortion pill compared with other common drugs, April 10, 2023
Obstetrics & Gynecology, Distance Traveled for an Abortion and Source of Care After Abortion, September 2017
Advancing New Standards in Reproductive Health, Abortion-related emergency department (ED) visits in the United States, June 2018
Contraception, First-trimester medical abortion with mifepristone 200 mg and misoprostol: a systematic review, January 2013
Guttmacher Institute, Medication Abortion, Feb. 1, 2021
Guttmacher Institute, Medication Abortion Now Accounts for More Than Half of All US Abortions, Feb. 24, 2022
Twitter, FDA statement, April 8, 2023
Kaiser Family Foundation, The Availability and Use of Medication Abortion, Feb. 24, 2023
U.S. Food and Drug Administration, Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation, Updated March 23, 2023
Email interview, Tracy Weitz, professor at American University and senior fellow with the Women's Initiative at American Progress, April 10, 2023
Email interview, Dr. Daniel Grossman, professor of obstetrics, gynecology and reproductive sciences at the University of California-San Francisco, April 10, 2023
Phone and email interview, Ushma Upadhyay, professor and public health scientist at the University of California, San Francisco, April 10, 2023
Email interview, Maarit Niinimäki, lead researcher on 2009 Finland study and consultant gynecologist at the University Hospital of Oulu, Finland, April 11, 2023
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