One drug medication abortion with misoprostol grows in US
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[April 20, 2023]
By Ahmed Aboulenein and Michael Erman
WASHINGTON (Reuters) - Use of the drug misoprostol on its own to
terminate pregnancies is on the rise in the United States as providers
seek a preemptive alternative while a ban on abortion pill mifepristone
is being considered in court.
Misoprostol is already part of the only medication abortion protocol
approved by the U.S. Food and Drug Administration, but only when taken
in combination with mifepristone.
The drug, which the FDA first approved in 1988 for gastric ulcers, is
often prescribed off-label to treat miscarriages or induce abortions.
"We have seen an increase in demand since the ruling earlier this
month," a spokesperson for Baudette, Minnesota-based ANI
Pharmaceuticals, one of the companies that makes misoprostol, told
Reuters. "We have ramped up our manufacturing and are currently prepared
to meet the increased demand we are seeing."
Planned Parenthood clinics in New York have ordered a year's supply of
misoprostol and administrators in several states have prepared
information on how to use it alone, the organization said.
![](http://archives.lincolndailynews.com/2023/Apr/20/images/ads/current/peasley_sda_SFARM_2023.png)
The moves to train doctors and produce more misoprostol could make a
meaningful difference in U.S. abortion access, which has further
dwindled since a Texas judge's ruling to halt use of mifepristone set
off a prolonged legal battle that has reached the Supreme Court.
It was the latest in a series of blows to abortion rights following the
Supreme Court's decision to overturn the landmark 1973 Roe v. Wade
ruling that had made the procedure legal nationwide. The court on
Wednesday extended a temporary block on limits set by lower courts on
access to mifepristone for a further two days.
The FDA has not approved a single-drug medication abortion regimen but
the World Health Organization (WHO) and the American College of
Obstetricians and Gynecologists recommend both the combination protocol
or misoprostol on its own, particularly when mifepristone is not legally
available or is inaccessible.
The FDA declined to comment on the use of a single-drug regimen for
medication abortions, which account for more than half of all U.S.
abortions.
Experts say misoprostol on its own is a safe alternative.
![](http://archives.lincolndailynews.com/2023/Apr/20/images/ads/current/culligan_sda_SFARM_2023.png)
"If providers are forced to stop providing mifepristone, misoprostol
alone is also safe and effective," said Dr. Ushma Upadhyay, a public
health professor at the University of California, San Francisco.
Upadhyay said it is slightly less effective at about 87%-93% compared to
95%-97% when used with mifepristone. It is also associated with nausea,
vomiting, and bleeding.
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![](../images/042023PIX/health55.jpg)
A box of Misoprostol, used to terminate
early pregnancies, is pictured in this illustration taken June 20,
2022. REUTERS/Edgard Garrido/Illustration/File Photo
![](http://archives.lincolndailynews.com/2023/Apr/20/images/ads/current/debbies_lda_032222.png) The drug is used alone all over the
world because it is much cheaper, less regulated, and more easily
available than mifepristone due to its use in treating many other
issues, including to induce labor, she said.
'KNOWN THIS WAS COMING'
Five U.S. telehealth providers told Reuters that after the Texas
ruling they were prepared to switch to a misoprostol-only regimen if
necessary.
"We've known this was coming for a little while so we could take a
number of steps to get ready, but still putting it into action and
updating our site to that one-pill regimen will take us a couple of
weeks," said Jenny Dwork, vice president of marketing at telehealth
provider Wisp.
Wisp, which operates in nine states, is not anticipating any supply
issues, said Dwork, and the switch would not impact cost.
While states and online pharmacies may be stocking up on the drug,
supply has held up, said Erin Fox, a professor at the University of
Utah who tracks U.S. drug shortages.
ANI, which makes a generic version of the drug, said last year the
annual U.S. market for misoprostol tablets was around $15 million,
citing data from healthcare analytics firm IQVIA/IMS Health.
![](http://archives.lincolndailynews.com/2023/Apr/20/images/ads/current/farmersgrain_sda_SFARM_2023.png)
Pfizer Inc, which produces and sells the medicine under the brand
name Cytotec, did not respond to requests for comment.
Because misoprostol is approved for medication abortion in the
United States as part of the two-drug combination, prescribing it
alone to terminate pregnancies would also be considered off-label.
Once medicines are approved in the U.S. for a specific use or
condition, doctors are generally free to prescribe them however they
see fit.
While anti-abortion groups and doctors seeking to ban mifepristone
over claims that the FDA's 2000 approval was unlawful, they are not
also going after misoprostol because of its other approved uses.
(Reporting by Ahmed Aboulenein in Washington and Michael Erman in
New York; Additional reporting by Sriparna Roy in Bengaluru, Brendan
Pierson in New York and Sharon Bernstein in Sacramento; Editing by
Caroline Humer and Bill Berkrot)
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