Supreme Court to Decide on Access to Mifepristone in Landmark Case

On Tuesday, March 26, 2024, the U.S. Supreme Court will take up a case that could impact how women get access to mifepristone, one of the two pills used in the most common type of abortion in the nation. Legal briefs filed with the court describe the pill's safety in vastly different terms: Medical professionals call it "among the safest medications" ever approved by the FDA, while the Christian conservative group suing the agency attributes "tens of thousands" of "emergency complications" to the drug.

Safety Limits Imposed by FDA

The FDA approved mifepristone in 2000 as a safe and effective way to end early pregnancies, imposing strict safety limits on who could prescribe and distribute it. The drug was initially available only through specially certified physicians and as part of three mandatory in-person appointments with the patient. Furthermore, these physicians were required to be capable of performing emergency surgery to stop excess bleeding and an abortion procedure if the drug didn't end the pregnancy. However, in 2021, the FDA decision did away with any in-person requirements and allowed the pill to be sent through the mail.

Frequency of Serious Problems

Abortion opponents argue that the more lax restrictions resulted in a significant increase in "emergency complications." However, medical organizations, including the American College of Obstetricians and Gynecologists, state that major adverse events occur in less than 0.32% of patients. The prescribing information included in the packaging for mifepristone tablets lists different statistics for "serious adverse reactions," with varying frequencies for complications such as transfusion, sepsis and hospitalization related to medication abortions.

Emergency Room Visits

Mifepristone's labeling lists ER visits as an option if patients experience prolonged heavy bleeding, severe abdominal pain, or a sustained fever. However, medical professionals point out that ER visits don’t always reflect significant problems, as some patients may go there just to be checked out or have questions but don’t have a doctor. A study in 2018 found that slightly more than half of patients who visited the ER because of abortions received only observational care.

Effectiveness of Mifepristone

Mifepristone results in a completed abortion 97.4% of the time, with a surgical intervention needed in 2.6% of cases. Additionally, about 0.7% of the time, the pregnancy continues. Dr. Pratima Gupta, a board member for the American College of Obstetricians and Gynecologists, emphasized that the chance of a procedural abortion failing to end a pregnancy is extremely low, probably less than 0.1%.

Comparison with Other Drugs

The FDA makes drug approval decisions on a case-by-case basis, considering factors such as effectiveness and safety. A 2021 review of agency records found 13 deaths likely related to mifepristone out of roughly 6 million patients who have taken the drug since 2000, indicating a death rate of .00027%. Medical organizations supporting mifepristone's availability compare the drug's safety to that of ibuprofen, which is widely used by more than 30 million Americans daily.