One drug medication abortion with misoprostol grows in US

[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.

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.

"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.

A box of Misoprostol, used to terminate early pregnancies, is pictured in this illustration taken June 20, 2022. REUTERS/Edgard Garrido/Illustration/File Photo

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.

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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