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A U.S. Food and Drug Administration report showed 28 deaths out of 5.6 million women who have taken the drug since it was approved in 2000 through June 30, 2022. But the FDA did not attribute these deaths to mifepristone.
Some of the deaths, such as ones caused by sepsis and ectopic rupture, could be plausibly related to mifepristone, experts said. But the cases listed also included patients who died by homicide, suicide and various drug overdoses.
As litigation over the abortion pill mifepristone plays out in court, abortion opponents are using social media to raise questions about its safety.
Mifepristone remains on the market amid the court battle, and more than 100 scientific studies have shown the medication to be a safe and effective way to end a pregnancy. But one nonprofit anti-abortion organization, Live Action, is warning that the medication was lethal for 28 women.
In a April 12 Instagram post that showed a picture of a woman lying on a blood-spattered bathroom floor, the group wrote that medication abortion "has been linked to the deaths of at least 28 women in the U.S. alone." In another Instagram post April 20 that showed a coat hanger, the group wrote that "mifepristone has caused thousands of women to be hospitalized, others to experience hemorrhaging, severe infections, AND 28 cases of maternal death."
These posts — which were flagged as part of Meta’s efforts to combat false news and misinformation on its News Feed — mischaracterize the fatality data on medication abortion, which include cases of homicide and drug overdoses.
(Read more about our partnership with Meta, which owns Facebook and Instagram.)
PolitiFact reached out to Live Action for comment. We did not hear back in time of publication.
Our search for sources on the 28 deaths figure led us to the U.S. Food and Drug Administration’s latest report on adverse events associated with mifepristone from September 2000 through June 30, 2022.
That report showed that out of 5.6 million women who took the drug in that period, 28 later died. But the report does not attribute these fatalities to the drug.
It reads, "These events cannot with certainty be causally attributed to mifepristone because of information gaps about patient health status, clinical management of the patient, concurrent drug use, and other possible medical or surgical treatments and conditions."
Nine cases associated with sepsis were among the 28 reported deaths, the report said. Other cases included incidents of homicide, suspected homicide, suicide, drug intoxication, drug overdoses and a natural death.
"Pregnancy itself is associated with roughly 1,000 deaths per year in the U.S., many more than mifepristone," said Dr. Erika Werner, chair of obstetrics and gynecology at Tufts Medical Center in Boston. "By definition, a death associated with a drug does not mean (it was) caused by that drug. In this case, all deaths that occurred in close temporal proximity to the medication were likely included."
The remaining deaths detailed in the FDA report included single cases of delayed-onset toxic shocklike syndrome, bilateral pulmonary thromboemboli (typically associated with blood clotting issues), hemorrhage, probable anaphylactic medication reaction and two cases of ruptured ectopic pregnancy. A cause of death could not be established in one case.
The FDA noted in its report that the fatal cases are included "regardless of their causal attribution to mifepristone." It said on its website that review of the data identified no new "safety signals," which means it did not raise alarms about drug safety that would merit further investigation.
Dr. Caleb Alexander, an epidemiology and medicine professor at Johns Hopkins Bloomberg School of Public Health, and a co-director of the Center for Drug Safety and Effectiveness, told PolitiFact that the nature of the deaths detailed in the report suggests that many, if not most of the cases, may have little to nothing to do with mifepristone.
"Some of these causes are more plausibly related to mifepristone than others, but many clearly have nothing to do with exposure to the drug," Alexander said. "You have methadone overdose, you have homicide, suicide, unintentional overdose causing liver failure — that’s not mifepristone."
Even if we include all 28 deaths, these posts omit the context that these events occurred among more than 5.6 million women over a 22-year timespan. That works out to a mortality rate of 0.0005%, far lower than many prescription drugs and over-the-counter medications, such as Tylenol.
More than 100 studies on the abortion pills have concluded that the medication regimen — which involves taking mifepristone and another pill, misoprostol, about 24 hours later — is safe and found that the rate of major complications requiring treatment, such as severe hemorrhages or infection, is very low. For example, one 2015 study on emergency department visits and complications after abortion assessed around 11,000 medication abortion cases and found that these types of complications amount to about one-third of a percent.
"This product has been evaluated very carefully by many well-trained and well-qualified scientists. There's not any substantive scientific debate or controversy about its safety and effectiveness," Alexander said.
Some anti-abortion groups that make these types of claims about mifepristone use data that has been cherry-picked or misconstrued, he added, while the FDA looks at all the evidence to determine whether a medication or therapy is safe.
"The FDA isn’t looking at one study or one case report," he said. "They're looking at the totality of information that they require the manufacturer to assemble, appraise and then provide and deliver."
Live Action claimed that mifepristone has caused 28 cases of maternal death.
This is a misreading of the available data. The FDA reported 28 out of 5.6 million people died between 2000 and 2022 after taking mifepristone, but the agency did not attribute those deaths to the drug. The report showed that these deaths included cases of homicide, suicide and drug overdoses.
The statement contains an element of truth — 28 deaths are listed in the report — but it omits critical facts about the nature of the deaths and number of patients involved that would give a different impression. We rate it Mostly False.
Click here to read more about PolitiFact’s methodology for independent fact-checking
The Washington Post, Supreme Court preserves access to key abortion drug as appeal proceeds, April 21, 2023
Instagram Live Action post, April 12, 2023
Instagram Live Action post, April 20, 2023
U.S. Food and Drug Administration, Mifepristone U.S. post-marketing adverse events summary through 06/30/2022, Accessed April 24, 2023
U.S. Food and Drug Administration, Questions and answers on mifepristone for medical termination of pregnancy through 10 weeks gestation, Jan. 4, 2023
The New York Times, Are Abortion Pills Safe? Here’s the Evidence, April 7, 2023
ANSIRH, Incidence of emergency department visits and complications after abortion, January 2015
PolitiFact, Do 1 in 5 women suffer complications from abortion pills? No. Group suing FDA shares flawed data, April 13, 2023
Phone interview, Dr. Caleb Alexander professor of epidemiology and medicine at Johns Hopkins Bloomberg School of Public Health, co-director of the Center for Drug Safety and Effectiveness, April 24-25, 2023
Email interview, Dr. Erika Werner, chair of obstetrics and gynecology at Tufts Medical Center, April 24, 2023
Email interview, U.S. Food and Drug Administration office of media affairs, April 24, 2023
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