The Supreme Court of the United States will hear a case on Tuesday that could potentially affect the accessibility of mifepristone, one of the medications used in the most prevalent form of abortion in the country.

The main point of contention in the case is whether the Food and Drug Administration failed to address significant safety concerns when it loosened restrictions for obtaining mifepristone, including through mail-order pharmacies.

The court has received conflicting statements about the safety of the pill. According to medical experts, the FDA has deemed it one of the safest drugs ever approved. However, the group suing the agency claims that the pill has caused tens of thousands of emergency complications.

Earlier this year, two studies that suggested the negative effects of mifepristone were revoked by a medical journal. These studies were used as evidence in a crucial Texas court decision that was then taken up by the Supreme Court. The publisher identified potential conflicts of interest and flaws in the research conducted by the authors, however the main author of the studies claims that the retractions were unjustified.

Learn more about the safety of mifepristone, a commonly paired medication with misoprostol for abortion.

In 2000, mifepristone was approved by the FDA as a reliable and safe method to terminate early pregnancies.

In some rare instances, mifepristone may result in severe and excessive bleeding, necessitating immediate medical attention. To ensure safety, the FDA has implemented stringent restrictions on those authorized to prescribe and dispense the drug. Specialized and certified physicians are permitted to do so, but only after three mandatory face-to-face appointments with the patient.

The physicians needed to be able to execute urgent surgical procedures to prevent excessive bleeding and terminate the pregnancy in case the medication was not effective.

Over time, the FDA has consistently confirmed the safety of mifepristone and has continuously relaxed regulations. This was exemplified by the recent 2021 ruling, which eliminated the need for in-person visits and permitted the medication to be delivered via mail.

Those against abortion argue that relaxed restrictions have led to a higher number of emergency complications. However, this generalized argument includes various scenarios involving mifepristone, including cases where the drug is not effective and instances where individuals simply have questions or concerns that do not require medical attention.

A small proportion of patients, according to OB-GYNs, experience “significant” or “severe” negative outcomes following the usage of mifepristone.

A legal document submitted by several medical associations, including the American College of Obstetricians and Gynecologists, states that a well-respected study involving over 50,000 patients found that the incidence of major adverse events, such as serious infection, excessive bleeding, or hospitalization, is less than 0.32% in patients undergoing medication abortion.

According to Ushma Upadhyay, a researcher involved in a 2015 study, the term “serious adverse events” typically encompasses blood transfusions, major surgery, hospitalizations, and death. Additionally, Upadhyay noted that hospital admissions serve as a broad category for extremely severe, though less common, occurrences like major infections.

The package insert for mifepristone tablets contains varying figures for significant negative effects, labeled as “serious adverse reactions.” These ranges show the frequency at which different complications may occur, such as 0.03% to 0.5% for transfusion, 0.2% for sepsis, and 0.04% to 0.6% for hospitalization related to medication abortions. According to experts, these ranges are based on results from multiple studies related to the topic.

The label for Mifepristone includes a potential complication that most medical organizations do not view as a serious or major adverse event: visits to the emergency room, which occurred in 2.9% to 4.6% of cases. The current FDA label states that going to the ER is an option if patients experience extended heavy bleeding, intense abdominal pain, or a persistent fever.

According to medical professionals speaking to The Associated Press, emergency room visits do not always indicate serious medical issues.

According to Upadhyay, a professor at University of California, San Francisco, individuals may visit the location following a medication abortion for a medical examination or to address any concerns if they do not have a physician. Additionally, some may choose not to discuss their abortion with their primary healthcare provider due to societal stigma.

In 2018, she co-authored a study which revealed that just over half of individuals who went to the emergency room due to abortion received only monitoring care. According to Upadhyay, some of these patients did not receive any form of treatment.

According to the FDA label, studies conducted in the United States have shown that Mifepristone leads to a successful abortion 97.4% of the time.

However, in 2.6% of situations, a surgical procedure is required. Additionally, there is a 0.7% chance that the pregnancy will progress.

Dr. Pratima Gupta, a member of the American College of Obstetricians and Gynecologists, stated that the chances of a procedural abortion performed in a clinic being unsuccessful in ending a pregnancy are “extremely, extremely low,” likely less than 0.1%, in comparison to a medication abortion.

The clinician confirms a complete abortion during or after the procedure by examining the tissue or performing an ultrasound.

According to Gupta, who has performed abortions for over two decades, the risk of complications is low regardless of the type of abortion – whether it be through medication or other procedures. A recent study also shows that this holds true for medication abortions done in a clinic, doctor’s office, or through telehealth from home.

The FDA evaluates drug approvals individually, considering factors such as effectiveness and safety before making a decision.

Not all medications are completely effective and a large number of commonly used drugs are not effective for a significant portion of patients.

Around 40% to 60% of individuals suffering from depression see improvement with the use of antidepressants. The FDA’s recent approval of new antibiotics tends to successfully treat approximately 70% of infections.

According to the FDA, approximately 6 million individuals have used mifepristone since 2000. Based on a review of 2021 FDA records, only 13 deaths, or .00027%, could be attributed to the drug.

According to medical organizations promoting the use of mifepristone, the drug has a safety record comparable to that of ibuprofen, a medication taken by over 30 million Americans daily, despite the reported deaths associated with it.

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The Howard Hughes Medical Institute’s Science and Educational Media Group provides assistance to the Associated Press Health and Science Department. The AP is solely responsible for the content published.