Why an ulcer drug could be the last option for many abortion patients

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Misoprostol is currently approved by the FDA for use as an ulcer drug, not as a standalone abortion pill. Doctors already use it off-label for a variety of gynecological purposes beyond abortion, including for IUD insertion and for labor and delivery. / AP

Updated February 24, 2023 at 8:51 AM ET

A federal judge in Texas could rule as soon as today on whether to cut off access to a key medication abortion protocol, giving lawyers until day's end to submit additional arguments. Fearing another major blow to abortion access, some providers are already considering alternatives.

At the Trust Women clinic in Wichita, Kansas, it's already been crisis mode for months. And now clinic Director Ashley Brink says the staff is bracing for another — maybe even bigger — wave of uncertainty.

"We're at an unprecedented time," Brink says. "We've never faced this kind of crisis, and so there is a lot of unknowns."

First, they got patients from Texas after that state's abortion ban took effect in 2021. Then, patients came from all over the region after last summer's landmark U.S. Supreme Court decision. And now, they're facing the possibility of a nationwide ruling that would block access to a common abortion pill.

An(other) unprecedented moment

In states where abortion is still legal, providers know they could soon lose the ability to prescribe the abortion drug mifepristone. A coalition of anti-abortion-rights groups, arguing that the drug was improperly approved, is asking the federal judge appointed by President Trump to overturn that approval.

Under the current two-drug protocol, the patient first takes mifepristone, which works by blocking progesterone, a hormone that helps a pregnancy progress. The second drug, misoprostol, then causes contractions to bring on what's essentially a medically induced miscarriage.

If the judge overturns the approval of that protocol, Brink says the Wichita clinic will only be able to offer patients either a surgical abortion or misoprostol alone. For now, that means preparing the staff with extra training on how to communicate to patients about the impact of the new protocol if they're forced to make the change.

"Because it is a different procedure than using the two-medication regimen with mifepristone," Brink says, "we're having to make sure everyone has the right language and the right information to ensure that they're communicating that effectively."

Downsides and unknowns

A recent study by the Guttmacher Institute found that 98% of medication abortions in the U.S. used the two-drug protocol in 2020.

But internationally, the second drug, misoprostol, has been used alone for decades, says Dr. Jamila Perritt, president and CEO of Physicians for Reproductive Health. Perritt says the case could leave both healthcare providers and patients facing complex medical and legal decisions about how to move forward without mifepristone.

"At this point, there are still a lot of unknowns in terms of how this is going to play out," Perritt says. "What we do know is that misoprostol has been used on its own for decades around the world and is effective at ending an early pregnancy."

The World Health Organization says misoprostol can be used effectively alone, often with additional doses.

There are downsides, though, including a higher risk of side effects like nausea and cramping, says Dr. Ushma Upadhyay, a public health professor at the University of California, San Francisco, who is researching the misoprostol-only protocol.

"It's so important that patients understand how long they'll be bleeding after they take the miso alone," she says. "And it is longer."

A learning curve

Most available research also suggests using only misoprostol is somewhat less effective than when it is combined with mifepristone.

Upadhyay says removing mifepristone from the equation will mean difficult decisions for doctors and patients, particularly those traveling from states where abortion is illegal: "I think it's going to be a huge learning curve for clinicians to figure out — what's the best, right protocol for this patient? How should I counsel this specific patient based on their legal risks and based on how far they traveled to get here?"

But for patients who don't want to undergo a surgical procedure, misoprostol alone may become the option of choice.

Leah Coplon, director of clinical operations for Abortion on Demand, a telehealth medication abortion clinic serving 23 states, says her organization is preparing to make the shift to misoprostol-alone if necessary.

"Obviously we hope that we can continue to use mifepristone and misoprostol, but we're ready if necessary," she says.

For now, Coplon says the clinic is working to update the information that would be provided to patients taking the drug. She's also preparing to order more doses of misoprostol, as well as "comfort medications" to help patients manage any additional pain they might experience with the single-drug protocol.

An alternative protocol

While most medication abortion patients in the United States choose the two-drug regimen, a small number already are using misoprostol alone.

Carafem, an organization that provides medication abortion through telehealth as well as at clinics in Chicago, Atlanta and outside Washington, D.C., began offering the single-drug protocol in 2020 amidst growing threats to abortion access in general and mifepristone in particular.

"It made sense to us to better understand how to use it and make it available," says Chief Operating Officer Melissa Grant.

Depending on the location, Grant says the two-drug protocol typically costs patients at Carafem around $199, compared with about $175 for misoprostol-only. Grant says about 10% to 15% of her clients choose misoprostol alone, in part because it's slightly less expensive than the two-drug protocol — a number she expects to grow if the mifepristone regimen becomes unavailable.

"We [would] have one less option, which is not good," Grant says. "This is the next step toward making abortion completely inaccessible across the country."

Meanwhile, Elisa Wells, co-founder of the group Plan C Pills, which provides information for people seeking abortion medications online, says her organization will continue to point clients toward alternative sources of both mifepristone and misoprostol.

Wells estimates that since the Dobbs v. Jackson Women's Health Organization decision last year, at least 30,000 people have obtained abortion pills through these networks.

"These alternative sources of pills ... may be the only option for people who are seeking an abortion solution," Wells says. "We know that there is a very robust pipeline of product coming into the U.S. right now and being distributed within the U.S."

An uncertain legal landscape

Abortion rights opponents are quick to point out that misoprostol is currently approved for use as an ulcer drug — not as a standalone medication to induce abortion.

"Misoprostol alone would not be an FDA-approved use of that drug for chemical abortion," says Julie Blake, senior counsel with Alliance Defending Freedom, which is representing the anti-abortion groups in the lawsuit challenging mifepristone's approval. "Using drugs that were approved for other purposes off-label certainly carries additional dangers and safety risks."

But off-label doesn't necessarily mean illegal, says Farah Diaz-Tello, senior counsel at If/When/How, a reproductive rights legal group.

"Off-label use of medications is very common; it happens every single day," Diaz-Tello says. "As long as it is within the standard of care that there isn't a problem with it."

But Blake's colleague, Alliance Defending Freedom attorney Erik Baptist, says he believes doctors who prescribe misoprostol for abortion could open themselves up to lawsuits.

"When it's prescribed off-label, that puts the doctor or the prescriber in a little more tenuous position when it comes to medical malpractice or tort liability in theory, because it's never been FDA-approved for that particular purpose," Baptist says.

The current lawsuit doesn't directly target off-label uses. Perritt of Physicians for Reproductive Health notes that misoprostol is already widely — and safely — used off-label for miscarriage management, in procedures like IUD insertion and for abortion. But she worries about an increasingly murky legal landscape surrounding abortion pills.

"If they're coming for mifepristone, believe me, they're coming for misoprostol. It will not end with the one medication," Perritt says. "And so all of this is at risk."

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