How Safe is the Abortion Pill Mifepristone?

Abortion pills are presently the most commonly used means of terminating a pregnancy in the United States, accounting for roughly two-thirds of all abortions. They have also emerged as a new battlefield in the United States’ battle for abortion access.

Much of the debate centers on mifepristone, one-half of the two-pill regimen that constitutes the safest and most effective method of pharmaceutical abortion. In June, the Supreme Court rejected a bid to limit access to the medicine.

However, the court left the door open for future challenges, which means the case might be in legal limbo again. Here’s an overview of mifepristone, what it does, and where it is used.

What is mifepristone?

The Food and Drug Administration (FDA) recommends two pills to stop a pregnancy, the first of which is mifepristone.

It works by preventing a hormone called progesterone, which is required for a pregnancy to progress. Misoprostol, the second medicine, helps to empty the uterus. According to US studies, the two-step pharmaceutical routine is 95% successful.

In September 2000, the US approved mifepristone for the medical termination of pregnancy up to seven weeks of gestation. In 2016, the permitted use period was increased to 10 weeks of pregnancy.

Misoprostol has been available on prescription for decades to treat stomach ulcers and postpartum hemorrhage. Its non-pregnancy-related uses are most likely why it has not generated as much criticism as mifepristone.

Meanwhile, mifepristone is used to treat miscarriages and Cushing syndrome, which is a hormone-related illness.

Between 2000 and 2018, the FDA reported that more than 3.7 million women in the United States used mifepristone.

Is Mifepristone safe?

For over 20 years, the FDA, the American College of Obstetrics and Gynaecologists (ACOG), and other major medical groups have maintained that mifepristone and misoprostol are safe to use.

According to US studies, the two-step drug regime is around 95% effective in terminating pregnancy and requires less than 1% of the time for additional medical follow-up.

Anti-abortion advocates are increasingly claiming that abortion medication, also known as “chemical abortion,” is dangerous and useless. However, reputable medical organizations such as the World Health Organisation and the American Medical Association do not back up their assertions.

According to the FDA, mifepristone causes five deaths per million users. In comparison, a 2001 study published in the Journal of the American Medical Association discovered that there were approximately 20 deaths per million penicillin users as a result of an adverse reaction to the routinely prescribed antibiotic.

Who questioned access?

The Alliance for Hippocratic Medicine, an umbrella group of anti-abortion doctors and activists, filed a lawsuit in November 2022, saying that mifepristone was hazardous and that the FDA erred by expediting the approval process and failing to sufficiently assess the safety hazards.

The FDA stated that the procedure was not rushed, taking four years and reviewing multiple studies with tens of thousands of participants before authorizing the abortion pill. The FDA did employ a provision in US drug regulations designed to help “fast-track” clearance processes, but it claimed it only used it to add additional limits for safety reasons, such as requiring women to be examined for the risk of ectopic pregnancies.

The lawsuit eventually reached the Supreme Court, which heard arguments in March 2024.

Three months later, in June, the justices unanimously concluded that the plaintiffs lacked a legal right to sue (known as standing) because they failed to demonstrate that the availability of mifepristone caused them injury.

“A plaintiff’s desire to make a drug less available to others does not establish standing to sue,” Justice Brett Kavanaugh wrote for the court.

Where is it available?

Mifepristone and misoprostol are readily available in states where abortion is permitted.

The medications’ availability was expanded in April 2021 when the FDA announced it would waive the in-person dispensing rule for mifepristone during the COVID-19 epidemic. In December last year, the FDA permanently relaxed that barrier, allowing the drug to be mailed.

Pro-choice advocates praised the decision. Some saw abortion drugs provided by mail as a workaround for the abortion laws that swept the country following Roe v Wade’s overturn last June.

Another FDA amendment in 2022 permitted retail pharmacies to deliver the medication, expanding access even further. Previously, only healthcare providers were allowed to distribute the medicine.