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Misoprostol is currently approved by the FDA for use as an ulcer drug, not 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.
Vittorio R. Caivano / AP
Updated Feb 24, 2023 at 8:51am ET
A Texas federal judge could rule as early today on whether to terminate access to a key protocol on medical abortion, giving attorneys until the end of the day to present further arguments. Fearing another blow to abortion access, some providers are already evaluating alternatives.
At the Trust Women clinic in Wichita, Kansas, she has already been in crisis mode for months. And now clinic director Ashley Brink says staff are bracing for another, possibly even bigger, wave of uncertainty.
“We are in an unprecedented time,” says Brink. “We’ve never faced this kind of crisis, so there are a lot of unknowns.”
First, they received patients from Texas after that state’s abortion ban went into effect in 2021. Then, patients came from across the region after last summer’s landmark U.S. Supreme Court decision . And now, they’re facing the possibility of a national ruling blocking access to a common abortion pill.
An (another) unprecedented moment
In states where abortion is still legal, providers know they may soon lose the ability to prescribe the abortion drug mifepristone. A coalition of anti-abortion rights groups, claiming the drug was improperly approved, is asking President Trump’s appointed federal judge to revoke that approval.
Under the current two-drug protocol, the patient first takes mifepristone, which works by blocking progesterone, a hormone that helps the pregnancy progress. The second drug, misoprostol, then causes the contractions to cause what is essentially a doctor-induced miscarriage.
If the judge reverses approval of that protocol, Brink says the Wichita clinic will be able to offer patients only a surgical abortion or misoprostol alone. For now, that means preparing staff with extra training on how to communicate to patients the impact of the new protocol if they’re forced to make the change.
“Because this is a different procedure than using the two-drug regimen with mifepristone,” says Brink, “we need to make sure everyone has the right language and the right information to ensure they’re communicating it effectively.”
Defects and unknowns
A recent Guttmacher Institute study found that 98 percent of medical abortions in the United States used the two-drug protocol in 2020.
But internationally, the second drug, misoprostol, has been used on its own for decades, says Dr. Jamila Perritt, president and CEO of Physicians for Reproductive Health. Perritt says the case could leave both healthcare professionals and patients faced with 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 it’s going to go down,” Perritt says. “What we do know is that misoprostol has been used on its own for decades around the world and is effective in ending an early pregnancy.”
The World Health Organization states that misoprostol can be used effectively on its own, often with additional doses.
There are downsides, however, including a higher risk of side effects like nausea and cramping, says Dr.
“It’s so important for patients to understand how long they’re going to bleed after taking miso on its own,” she says. “And it’s longer.”
A learning curve
Most of the available research also suggests that using misoprostol alone is somewhat less effective than when it is combined with mifepristone.
Upadhyay says removing mifepristone from the equation will lead to difficult decisions for doctors and patients, particularly those traveling from states where abortion is illegal: “I think it will be a huge learning curve for doctors to figure out what the best and right protocol for this patient? How should I advise this specific patient based on his legal risks and based on the distance he has traveled to get here?”
But for patients who don’t want to have surgery, misoprostol alone may become the option of choice.
Leah Coplon, director of clinical operations for Abortion on Demand, a telehealth drug abortion clinic serving 23 states, says her organization is preparing to switch to misoprostol alone if needed.
“Obviously we hope to be able to continue using mifepristone and misoprostol, but we are ready if needed,” she says.
For now, Coplon says the clinic is working on updating the information it will provide to patients taking the drug. It’s also preparing to order more doses of misoprostol, as well as “comfort drugs” to help patients manage any additional pain they might experience with the single-drug protocol.
An alternative protocol
While the majority of drug abortion patients in the United States choose the two-drug regimen, a small number are already using misoprostol alone.
Carafem, an organization that provides abortion drugs through telemedicine and at clinics in Chicago, Atlanta and outside Washington, DC, began offering the single-drug protocol in 2020 amid growing threats to access to abortion drugs. abortion in general and mifepristone in particular.
“It made sense for us to better understand how to use it and make it available,” says Melissa Grant, Chief Operating Officer.
Depending on the location, Grant says the two-drug protocol typically costs Carafem patients about $199, compared to about $175 for misoprostol alone. Grant says about 10 to 15 percent of his clients choose misoprostol alone, in part because it’s slightly less expensive than the two-drug protocol, a number he expects to rise if the mifepristone regimen becomes unavailable.
“We [would] having one less option, which is not good,” Grant says. “This is the next step in making abortion completely unaffordable across the country.”
Meanwhile, Elisa Wells, co-founder of the Plan C Pills group, which provides information to people searching for abortion medications online, says her organization will continue to refer customers to alternative sources of both mifepristone and misoprostol.
Wells estimates that since the Dobbs v. Jackson Women’s Health Organization In last year’s decision, at least 30,000 people obtained abortion pills through these networks.
“These alternative sources of pills…may be the only option for people looking for an abortion solution,” Wells says. “We know there is a very robust pipeline of products arriving in the US right now and being distributed within the US”
An uncertain legal landscape
Opponents of abortion rights are quick to point out that misoprostol is currently approved for use as an ulcer drug, not as a standalone drug to induce abortion.
“Misoprostol alone would not be an FDA-approved use of that chemical abortion drug,” says Julie Blake, senior counsel at Alliance Defending Freedom, which represents anti-abortion groups in the lawsuit challenging mifepristone’s approval. “The off-label use of drugs approved for other purposes certainly comes with additional dangers and safety risks.”
But off-label doesn’t necessarily mean illegal, says Farah Diaz-Tello, senior adviser to If/When/How, a reproductive rights law group.
“Off-label use of medications is very common; it happens every single day,” says Diaz-Tello. “As long as it’s within the standard of care 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 be open to lawsuits.
“When it’s prescribed off-label, that puts the doctor or prescriber in a little more tenuous position when it comes to medical malpractice or tort liability in theory, because it’s never been approved by the FDA for that particular purpose,” he says. baptist.
The current lawsuit does not directly target off-label uses. Perritt of Physicians for Reproductive Health notes that misoprostol is already widely – and safely – used off-label for the management of miscarriage, in procedures such as IUD insertion and for abortion. But she is concerned about an increasingly murky legal landscape surrounding abortion pills.
“If they’re coming for the mifepristone, trust me, they’re coming for the misoprostol. It’s not going to end with the one drug,” Perritt says. “And so all of this is at risk.”
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