Two Georgia deaths are tied to abortion restrictions. Experts say abortion pills they took are safe
Vice-Chairman Kamala Harris is expected speak about abortion Friday in Georgia, where the deaths of two women have been linked to a state law that largely bans the procedure after about six weeks.
Amber Thurman died after waiting 20 hours at a hospital to treat complications from taking abortion pills. Reported by ProPublica Earlier this week, it became the first publicly reported case of a woman dying from delayed care related to a state abortion law.
The news organization also reported on the death of Candi Millera woman with lupus, diabetes and hypertension who took abortion pills she ordered online. An autopsy found fetal tissue that had not been expelled and a lethal combination of painkillers, ProPublica reported. The state’s Maternal Mortality Review Board did not believe abortion medications caused her death.
Still, the fact that both women were taking the pills — mifepristone and misoprostol — may raise 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 terminate early pregnanciesThe drug, which blocks the hormone progesterone, also prepares the uterus to respond to the contraction-causing effect of another drug that is typically used with it, misoprostol. The pills are used in more than six in ten abortions at the national level.
There are rare cases in which mifepristone may cause severe bleeding requiring emergency attention.
So the FDA initially set strict safety limits on who could prescribe and distribute it — only specially certified physicians and only as part of three mandatory in-person appointments with the patient receiving the drug. The doctors also had to be able to perform emergency surgery to stop excessive bleeding and to perform an abortion procedure if the drug didn’t end the pregnancy.
Over the years, the FDA has reaffirmed the safety of mifepristone and repeatedly loosened restrictions, culminating in a 2021 ruling that removed the in-person consultation requirement and now allows the pill to be shipped by mail.
In 2022, a coalition of anti-abortion groups filed a federal lawsuit against the FDA, challenging the agency’s longstanding approval of mifepristone. Judges ruled In June it was declared that abortion opponents had no legal right to sue and that access to the medication would be maintained.
Abortion opponents say the looser restrictions have led to many more “emergency complications.” But that argument lumps together women who face a range of problems with mifepristone — from the drug not working to those who simply have questions or concerns but don’t need medical attention.
Gynecologists say a small proportion of patients experience “serious” or “serious” side effects after taking mifepristone.
A legal document from a group of medical organizations, including the American College of Obstetricians and Gynecologists, states: “When used in medical abortion, serious adverse events — significant infection, excessive bleeding, or hospitalization — occur in less than 0.32% of patients, according to a highly respected study of more than 50,000 patients.”
The definition scientists typically use for serious adverse events includes blood transfusions, major surgery, hospitalizations and death, said Ushma Upadhyay, one of the authors of that paper. Study from 2015.
The prescribing information on the packaging of mifepristone tablets lists slightly different statistics for what it calls “serious adverse events.” It cites ranges for how often various complications occur: 0.03% to 0.5% for transfusion; 0.2% for sepsis; and 0.04% to 0.6% for hospitalization related to medical abortions. The ranges reflect findings in several relevant studies, experts said.
Mifepristone’s labeling also lists a complication that most medical groups do not consider a serious or major side effect: ER visits, which ranged from 2.9% to 4.6%. Current FDA labeling lists going to the ER as an option if patients experience prolonged heavy bleeding, severe abdominal pain, or persistent fever.
But a visit to the emergency room doesn’t always indicate major problems, doctors told The Associated Press.
Some people go there after a medication abortion because they want to be tested or have questions but don’t have a doctor, said Upadhyay, a professor at the University of California, San Francisco. Others, she said, “don’t want to go to their family doctor about their abortion” because of the stigma.
A study of which she was co-author In 2018, it found that just over half of patients visiting the ED for abortions received only observational care. Some, Upadhyay said, “receive no treatment at all.”
According to American studies cited in the FDA package insert, mifepristone leads to completed abortion in 97.4% of cases.
But in 2.6% of cases, surgery is needed. And in 0.7% of cases, the pregnancy continues.
That compares to a procedural abortion in a clinic, where the chance that the procedure will not terminate a pregnancy is “extremely, extremely low,” probably less than 0.1 percent, said Dr. Pratima Gupta, a board member of the Faculty of Gynecology and Obstetrics.
“Every time a procedural abortion is performed, the clinicians make sure it was a complete abortion” by examining the removed tissue or performing an ultrasound during or after the procedure, she said.
Gupta, who has been performing abortion procedures for more than 20 years, said there are “very few complications with abortion — any type of abortion, medication or procedural abortion.” recent study suggests that this applies equally to medical abortions that take place in a clinic, with a doctor, or at home using telehealth.
The FDA makes drug approval decisions on a case-by-case basis, considering effectiveness, safety, and other factors.
No medicine is 100% effective and many common medications do not work for a large proportion of patients.
Antidepressants typically help between 40% and 60% of people with depression. New antibiotics approved by the FDA often clear up about 70% of infections.
About 6 million patients have used mifepristone since 2000, according to the FDA. A 2021 review of the agency’s data looking for deaths likely related to the drug identified 13, or 0.00027% of patients.
Medical organizations supporting the availability of mifepristone say the drug’s safety — given its death rate — is comparable to “ibuprofen, which more than 30 million Americans take on any given day.”
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.