The Pills That Make Up A Medical Abortion Regimen Are Under Legal Threat

Long experience and repeated studies show the pills are safe, but political and cultural factors are impeding access

by Emily Kim

Mifepristone, a commonly used abortion pill, is available nationwide today; however, this could instantly change tomorrow. 

Mifepristone, also known as RU-486 or ‘Mifeprex’, is used most commonly as an abortion pill. It works by blocking the hormone progesterone which is necessary for pregnancy to continue, causing the uterus to contract and terminate the pregnancy. Moreover, this medication is taken in combination with another medication called misoprostol, which helps to soften and open the cervix. 

“Mifepristone is a very safe drug, used exclusively for the initiation of medication abortions,” says Carol Hogue, Ph.D., M.P.H., Professor emerita of maternal and child health at Rollins School of Public Health at Emory University. 

Mifepristone has a 95-99% effective rate and allows patients to end their pregnancy where they feel comfortable, while given the medical treatment and support that they need. 

“There are decades of strong data supporting the safety of mifepristone. It was first FDA approved in the United States in the year 2000,” says Lauren Owens, M.D., M.P.H., Associate professor of obstetrics and gynecology at the University of Washington Medical Center. “And it actually was approved in France back in 1988.” 

Owens goes on to explain more decades-old data on mifepristone that evaluates its safety and effectiveness. She highlights a 2013 review of over 45,000 medical abortions that exhibited a 1.1% rate of ongoing pregnancy and a less than 0.4% risk of getting hospitalized or having to receive a transfusion. 

“So this means medication abortion with mifepristone and misoprostol has a better safety profile than other commonly used medications like Tylenol or Viagra,” says Lauren Ralph, Ph.D., M.P.H., Associate professor of the department of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco. 

Additionally, the safety and effectiveness of misoprostol compares similarly to that of mifepristone. According to Lauren Owens, both medications are very safe and effective, especially with 200 mg of mifepristone and 800 micrograms of misoprostol. 

“We do know that the mifepristone and misoprostol is more effective together than the misoprostol 800 micrograms alone,” says Lauren Owens. 

Furthermore, usage of both medications result in serious risk 0.5% of the time and for just misoprostol alone, the cases are just 0.7%. So, across both methods, the cases of serious risk are less than 1% for a pregnant person, which are hospitalization, blood transfusion or surgery. Moreover, both regimens are effective in terminating pregnancy. 

“Medication abortion with mifepristone and misoprostol has effectiveness of 97% through 10 weeks of pregnancy, and about 95% at 10 to 12 weeks of pregnancy. Medication abortion with misoprostol alone has a somewhat lower effectiveness. However, it’s really still quite effective, with studies showing effectiveness ranging from 87 – 93%, depending on factors such as the number of misoprostol doses taken and the route of administration of the medication,” says Dr. Lauren Ralph. 

Despite this, a federal judge in Texas, Matthew J. Kacsmaryk, ruled to suspend the FDA’s approval of mifepristone on April 17th, 2023, attacking piles of expert-backed evidence and research on mifepristone. 

Not only did this court decision suspend the usage of abortion pills, but also limited access to abortion itself.  

“Limiting access to abortion itself is a major public health problem for women. Right now, maternal mortality is the sixth leading cause of death for women aged 15 to 34. The fact is, it’s not listed as one of the top ten causes of death because it it happens only to women—and only women of reproductive age,” says Carol Hogue. 

Nevertheless, abortion is currently the sixth leading cause of death for women. And it will further increase as the restrictions against abortion are only getting stronger. According to Carol Hogue, this has happened before. In 1995, abortion restrictions increased across the country, which set a clear distinction between maternal mortality rates in states that had restricted abortions and those that did not. 

Medically, women who are healthy at six weeks or 12 weeks of pregnancy could develop preeclampsia, leading to postpartum hemorrhage, and ultimately death at the time of delivery or after delivery. 

“And women are exposed to those risks, irrespective of whether they want to have the pregnancy or not,” says Carol Hogue.

More importantly, “medication abortion accounts for more than half of all abortions in the U.S. today,” says Lauren Ralph. “So the impact of banning mifepristone would be devastating, especially for people who are already facing barriers to abortion like having to travel hundreds of miles to the nearest clinic and navigate longer wait times at these clinics.”

 Furthermore, offering people who are pregnant several options to abortion is beneficial. Some prefer to take medications for abortion as it provides privacy, flexibility, and less healthcare system interactions that other options cannot give. 

“For example, during the COVID-19 pandemic, we saw many abortion providers offering medication abortion using telehealth, and this allowed us to study these models of care and learn that they’re safe, effective and well liked by patients. So removing or limiting options for abortion isn’t in the patient’s best interest or supported by research evidence,” says Lauren Ralph.

However, abortion decisions must be made quite early. 

“Research has shown us that medical abortions are as effective as surgical abortions, but we need to consider that we want to use medical abortion earlier in the pregnancy. So it’s effective, especially effective, up to ten weeks of pregnancy,” says Claire Brindis, Dr.P.H. Founding director of the Bixby Center for Global Reproductive Health at the University of California, San Francisco. 

Although studies on the usage of abortion pills after 24 weeks of gestation have been studied, this is often recommended against. According to a literature review by the National Institute for Health and Care Excellence (2019), the uterus becomes more sensitive after 24 weeks of gestation, which creates a lower dosage of misoprostol regimen. And yet, the lower dosage may not reduce risk, rather it may increase the rate of failure to end a pregnancy. 

With the current protocol for providing mifepristone and misoprostol before 24 weeks, there is a very low chance of developing any complications. The research behind abortion pills have been extensively studied and tested amongst millions of patients in the United States.

 “We have found that medical abortions have had a very low incidence of any type of complications. Less than one percent—0.4 percent of women—experience any kinds of additional complications, such as heavier bleeding, low-grade fevers, and some additional pelvic pain that over time is eliminated,” says Dr. Brindis.

Not only are the evidence behind abortion pills well studied and supported, but so are the consumers taking them. 

Dr. Brindis says, “One thing that is very important to recognize is that many of these women are savvy consumers of knowledge and information. They will seek out advice either from friends who’ve already had one or from other internet resources that help them prepare for what to expect, first, before, during, and after.” 

Unsurprisingly, people self-managed abortion for thousands of years. The main difference between then and now is that there are more options for abortion. 

“And that people will seek care from a clinician if they have a question or concern about a complication. So as a physician I don’t have concerns really about the medical risks so much from self-managed abortion using these medications,” says Dr. Grossman. “I do have concerns about the legal risks that patients may take. We know that a number of people, more than twenty, have been arrested or prosecuted or even imprisoned for allegedly attempting to self-manage their abortion or for helping someone else self-manage their abortion.”

Today, mifepristone access remains largely unknown. The abortion pill is either restricted or banned in 27 states and some federal courts have set severe restrictions on mifepristone in states where abortion pills are legal. 

It is also worth noting that while mifepristone is highly effective at inducing abortion, it may not be suitable for everyone. Your healthcare provider can help you determine if mifepristone is the right option for you, and can provide information on other options for ending a pregnancy if necessary.