(CNN) — A federal judge in Texas will preside over a hearing Wednesday morning in a lawsuit seeking to block nationwide access to mifepristone, one of the drugs required in the abortion process.
Data reviewed by CNN shows that mifepristone is even safer than some of the most common, low-risk prescription drugs, including penicillin and Viagra. There were five deaths associated with the use of mifepristone for every 1 million people in the US who used the drug from its approval in 2000 through last summer, according to the US Food and Drug Administration (FDA, for its acronym in English). This assumes a mortality rate of 0.0005%.
By comparison, the risk of death from penicillin, an antibiotic commonly used to treat bacterial infections such as pneumonia, is four times that of mifepristone, according to a study of severe allergic reactions. The risk of dying from the use of Viagra, an erectile dysfunction drug, is nearly 10 times higher, according to a study cited in a report filed by the FDA.
“[La mifepristona] it has been used for more than 20 years, by more than five million people with the possibility of becoming pregnant,” said Ushma Upadhyay, an associate professor in the department of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco. “Their security is well established.”
The lawsuit, brought by a coalition of anti-abortion national medical associations against the FDA, under the “Hippocratic Medicine Alliance” and various physicians, seeks a series of court actions, primarily an injunction ordering the FDA to “Withdraw mifepristone and misoprostol as FDA-approved drugs for chemical abortion and withdraw defendants’ actions to deregulate these chemical abortion drugs.”
“Plaintiffs now ask this court to do what the FDA was and is legally required to do: protect women and girls by outlawing, striking down, and setting aside FDA’s actions to approve chemical abortion drugs and eliminate crucial safeguards for those who undergo this dangerous drug regimen,” they wrote in their initial lawsuit.
If the lawsuit is successful, an additional 40 million women of reproductive age would lose access to medical abortion services across the country, according to data from abortion rights advocacy group NARAL Pro-Choice America. This number is in addition to the 24.5 million women of reproductive age who live in states that prohibit abortion.
“It goes against decades of scientific and clinical evidence,” says Dana Johnson, a doctoral candidate in public policy and demographics at the University of Texas at Austin, who researches abortion access and health care. “The fact that this lawsuit could undermine something that we know is extremely safe, extremely effective, and is one of the most accessible forms of abortion right now, I think is absolutely terrifying.”
Weighing medical abortion against the alternatives
Chemical or medical abortion has become the most common method of abortion, accounting for more than half of all abortions in the US in 2020, according to the Guttmacher Institute.
The growing popularity of medical abortion is largely due to its accessibility, says Abigail Aiken, an associate professor at the University of Texas at Austin who leads a medical abortion research group.
“It reduces the cost and the barriers that prevent people from going to a clinic,” he says.
It is also a safer option than surgical abortion or childbirth. The rate of serious complications, such as bleeding or infection, in medical abortions is 0.31%, according to a 2015 study led by Upadhyay.
According to the same study, the probability of serious complications in a surgical abortion, performed in the second trimester or later, is slightly higher than that of a medical abortion, at 0.41%. And childbirth carries by far the highest risk, at 1.3%.
If access to mifepristone is cut off, abortion clinics and telehealth organizations could switch to performing misoprostol-only abortions, Aiken explained to CNN. Although misoprostol-only abortions are used worldwide, they are less effective, are associated with a higher risk of serious complications, and are often more painful than the combination of mifepristone and misoprostol, she explained.
In the latest study of self-managed medical abortions using misoprostol alone in the US, Johnson concluded that it is a safe alternative, albeit less than the combined use of both pills. The study, published in February, analyzed data from telehealth online medical abortion provider Aid Access from 2020. Nearly 90% of the 568 clients reported completed abortions and 2% experienced serious complications using misoprostol alone.
Mifepristone and misoprostol together are still considered the gold standard, Aiken told CNN. People who used the two-pill combination were less likely to experience serious complications than those who chose the misoprostol-only regimen.
“It’s clear that people can use these medications, mifepristone and misoprostol, at home even without the help of a medical professional very safely,” Aiken said.
Since misoprostol is used to treat multiple ailments, including stomach ulcers, it is readily available in pharmacies and is unlikely to be withdrawn from the market anytime soon, Johnson told CNN.
However, a less effective method means that more people are likely to have unsuccessful abortions.
“It may not work for some people and may prolong their miscarriages,” Upadhyay said. “Then by the time they come back to the clinic, they’ll look to abort with a later pregnancy.”
Before the sentence, 19 states already restricted care to telehealth abortion, limiting access to medical abortion. According to a survey by the Kaiser Family Foundation, as of late January nearly half of American adults did not know whether medical abortion was legal in their state. Experts say this confusion will only get worse.
“People aren’t going to be sure if mifepristone or misoprostol is available. I think it’s going to be confusing,” Aiken says. “As people search for options or feel insecure about their options, they may end up delaying [la atención]”.
— CNN’s Devan Cole contributed to this report.