Global Courant
The U.S. Supreme Court will hear a case Tuesday that could affect how women get access to mifepristone, one of two pills used in the country’s most common form of abortion.
The central dispute in the case is whether the Food and Drug Administration overlooked serious safety problems when it made mifepristone more readily available, including through mail-order pharmacies.
Legal papers filed in court describe the pill’s safety in starkly different terms: Medical professionals call it “one of the safest drugs” ever approved by the FDA, while the Christian conservative group suing the agency has reported “tens of thousands” of “emergency complications.” ” attributes. to the medicine.
Earlier this year, a medical journal retracted two studies that claimed to show mifepristone’s harm. The studies were cited in the pivotal Texas court ruling that brought the case to the Supreme Court. The publisher cited the authors’ conflicts of interest and shortcomings in their research, although the lead author of the studies called the retractions a baseless attack.
Here’s what you need to know about the safety of mifepristone, which is typically used with misoprostol in a medication abortion.
The FDA approved mifepristone in 2000 as a safe and effective way to end early pregnancies.
There are rare cases where mifepristone can cause dangerous, excessive bleeding that requires emergency care. So the FDA imposed strict safety limits on who could prescribe and distribute the drug – only specially certified physicians and only as part of three mandatory in-person appointments during which the patient received the drug.
The doctors also had to be able to perform emergency surgery to stop excessive bleeding and perform an abortion procedure if the drug did not terminate the pregnancy.
Over the years, the FDA has reaffirmed mifepristone’s safety and repeatedly loosened restrictions, culminating in a 2021 decision that eliminated all in-person requirements and allowed the pill to be shipped by mail.
Opponents of abortion say the laxer restrictions have led to many more “emergency complications.” But that argument lumps together women who experience a range of problems with mifepristone — from the drug not working to people who may simply have questions or concerns but don’t need medical care.
OB-GYNs say a small portion of patients experience “major” or “severe” 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 with abortion medications, major side effects – significant infections, excessive blood loss, or hospitalization – occur in less than 0.32% of patients. to a highly regarded study with more than 50,000 patients.”
The definition scientists generally use for serious side effects includes blood transfusions, major surgeries, hospitalizations and death, said Ushma Upadhyay, one of the authors of that 2015 study. She added: “Hospitalization is an umbrella term for the very serious , but rarer events, such as a major infection.”
The prescribing information in the packaging of mifepristone tablets lists slightly different statistics for what it calls “serious side effects.” Margins are given for how often various complications occur: 0.03% to 0.5% for transfusion; 0.2% for sepsis and 0.04% to 0.6% for hospital admissions related to medication abortions. The ranges reflect findings from several relevant studies, experts said.
Mifepristone’s labeling also mentions 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%. The current FDA label states that going to the emergency room is an option if patients experience prolonged heavy bleeding, severe abdominal pain, or persistent fever.
But ER visits don’t always reflect major problems, doctors told The Associated Press.
Some people may go there after a medication abortion because they want to be examined or have questions but don’t have a doctor, says Upadhyay, a professor at the University of California, San Francisco. Others, she said, “don’t want to go to their doctor about their abortion because of the stigma.”
A study she co-authored in 2018 found that just over half of patients visiting the ER for abortions received only observational care. Some, Upadhyay said, “are not receiving any treatment.”
According to US studies noted in the FDA label, mifepristone results in a completed abortion 97.4% of the time.
But in 2.6% of cases, surgical intervention is required. And 0.7% of the time the pregnancy continues.
That’s compared to a procedural abortion in a clinic, where the chance of the procedure failing to end a pregnancy is “extremely, extremely low,” probably less than 0.1%, said Dr. Pratima Gupta, board member of the American College of Obstetricians. and Gynecologists.
“Every time a procedural abortion is performed, doctors ensure that 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 two decades, said there are “very few complications with abortion – any form of abortion, medication or procedural abortion.” A recent study shows that this is equally true for medication abortions that take place in a clinic, at a doctor’s office or at home using telehealth.
The FDA makes drug approval decisions on a case-by-case basis, weighing effectiveness, safety and other factors.
No drug is 100% effective and many common medications do not work for a significant portion of patients.
Antidepressants typically help between 40% and 60% of people with depression. New antibiotics approved by the FDA often clear about 70% of infections.
According to the FDA, approximately 6 million patients have used mifepristone since 2000. A 2021 review of agency data looking for deaths likely linked to the drug identified 13, or 0.00027%, of patients.
Medical organizations that support mifepristone’s availability say the drug’s safety — given the number of deaths — 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.
