Vice President Kamala Harris is expected to speak on abortion on Friday in Georgia, where two women have died because of a state law banning abortions after six weeks of pregnancy.
Amber Thurman died after waiting 20 hours for a hospital to treat complications from taking abortion pills. The case, reported by ProPublica earlier this week, is the first officially reported case of a woman dying due to delayed treatment under a state abortion law.
The news agency also reported the death of Candy Miller, a woman with lupus, diabetes and high blood pressure who took an abortion pill she ordered online. ProPublica reported that an autopsy found fetal tissue that had not been expelled and a lethal combination of painkillers. The state’s maternal mortality review board did not believe the abortion pill caused her death.
Still, the fact that both women used pills called mifepristone and misoprostol raises questions about their safety. Here are some facts.
The U.S. Food and Drug Administration approved mifepristone in 2000 as a safe and effective way to end an early pregnancy. The drug, which blocks the hormone progesterone, also prepares the uterus to respond to the contractile effects of misoprostol, another drug commonly used together. The pill is used in more than six out of 10 abortions nationwide.
Mifepristone rarely causes excessive bleeding that requires emergency treatment.
That’s why the FDA initially imposed strict safety limits on who could prescribe and distribute it: only specially certified physicians, and only as part of three mandatory face-to-face appointments with patients receiving the drug. Physicians were also required to perform emergency surgery to stop excessive bleeding and abortions if the medications didn’t end the pregnancy.
Over the years, the FDA has reaffirmed the safety of mifepristone and repeatedly eased restrictions, including in 2021 when it lifted the in-person requirement and allowed the drug to be sent by mail.
In 2022, a coalition of anti-abortion groups filed a federal lawsuit challenging the FDA’s longstanding approval of mifepristone. Judges ruled in June that abortion opponents had no legal right to sue, preserving access to the drug.
Abortion opponents say looser regulations have led to more “emergency complications.” But that argument lumps together a range of women who have had problems with mifepristone, from those who find the drug ineffective to those who simply have questions or concerns but do not need medical care.
Obstetricians and gynecologists say a small number of patients experience “serious” or “serious” side effects after taking mifepristone.
Here’s a legal summary from a group of medical organizations, including the American College of Obstetricians and Gynecologists: “Authoritative studies of more than 50,000 patients show that when used for medical abortion, major adverse effects such as serious infection, excessive bleeding, or hospitalization occur in less than 0.32% of patients.”
Ushma Upadhyay, one of the authors of the 2015 study, said the definition scientists typically use for serious adverse events includes blood transfusions, major surgery, hospitalizations and death.
The prescribing information included in the package of mifepristone tablets gives slightly different statistics on what it calls “serious adverse events.” It cites a range for the frequency with which various complications occur: 0.03% to 0.5% for blood transfusions, 0.2% for sepsis, and 0.04% to 0.6% for hospitalizations related to medical abortion. Experts say this range reflects the results of various related studies.
The label for mifepristone included emergency room visits, a complication that most medical groups do not consider serious or major side effects, at rates ranging from 2.9% to 4.6%. The current FDA labeling lists an emergency room visit as an option if the patient experiences prolonged, severe bleeding, severe abdominal pain, or persistent fever.
But an emergency room visit doesn’t always indicate a major problem, doctors told The Associated Press.
Upadhyay, a professor at the University of California, San Francisco, said some people want to be tested or have questions after a medical abortion but can’t find a doctor to go to. Others “don’t want to go to their primary care physician about an abortion” because of the stigma, she said.
A study she co-authored in 2018 found that more than half of patients who visited emergency rooms for abortions received only observation care. Some, according to Upadhyay, “received no treatment at all.”
According to a U.S. study cited in the FDA label, mifepristone is 97.4% effective in completing an abortion.
However, in 2.6% of cases, surgical intervention is required, and in 0.7% of cases, the pregnancy continues.
That compares to a surgical abortion performed in a hospital, where the chance that the procedure won’t end the pregnancy is “very, very low,” perhaps less than 0.1 percent, said Dr. Pratima Gupta, a member of the board of directors of the Society of Obstetricians and Gynecologists.
“Whenever a clinical abortion is performed, the clinician examines the removed tissue or performs an ultrasound during or after the procedure to make sure it is a complete abortion,” she said.
“There are very few complications from abortion, whether it’s a medical abortion or a surgical abortion,” says Gupta, who has been performing abortions for more than 20 years. Recent studies show that this is also true for medical abortions done in a hospital, doctor’s office, or at home, with the help of telemedicine.
The FDA makes drug approval decisions on a case-by-case basis, considering effectiveness, safety, and other factors.
No medication is 100% effective, and many common medications don’t work for many patients.
Antidepressants typically help 40% to 60% of people with depression. New FDA-approved antibiotics often clear up about 70% of infections.
According to the FDA, about 6 million patients have taken mifepristone since 2000. A 2021 review of agency records looking for deaths possibly related to the drug identified 13 patients (.00027%).
Medical organizations supporting mifepristone’s availability say the drug’s safety profile, when factoring in mortality, is similar to that of “ibuprofen, which is taken daily by more than 30 million Americans.”
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Education Media Group. AP is solely responsible for all content.
