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How Texas ruling banning mifepristone could impact abortion care

Written by on April 10, 2023

(WASHINGTON) — Last week’s decision from a federal judge in Texas has thrown access to a common abortion pill into limbo.

In the ruling, Judge Matthew Kacsmaryk of the Northern District of Texas reversed the U.S. Food and Drug Administration’s approval of mifepristone, potentially blocking access to the abortion medication across the country.

Kacsmaryk stayed his own order for seven days to give the federal government time to file an appeal, which it has already done.

However, immediately after that decision, U.S. District Judge Thomas Rice in Washington state issued a ruling barring the FDA from pulling mifepristone off the market.

For the time being, the medication is available, but the conflicting decisions mean a battle is almost certainly heading to the Supreme Court — and are confusing for patients who may need access to the pills.

‘Understanding what it means, how soon that might go into effect, all of these things are sort of unclear for a lot of a lot of people,” Dr. Sadia Haider, an OBGYN at Rush University Medical Center in Chicago, told ABC News. “And I do think it’s confusing, and it’s concerning, both from a provider and patient standpoint.”

Mifepristone is a drug typically used in combination with another drug, misoprostol, to induce an abortion or to help manage an early miscarriage.

The medication works by blocking progesterone, a hormone that the body needs to continue a pregnancy.

This causes the uterine lining to stop thickening and to break down, detaching the embryo. The second drug, misoprostol, taken 24 to 48 hours later, causes the uterus to contract and dilates the cervix, which will expel the embryo.

The FDA authorized mifepristone for medication abortion in September 2000 for up to seven weeks’ gestation, which was then extended to 10 weeks’ gestation in 2016.

However, the World Health Organization says the two drug-regiment can be taken up until the 12-week mark of pregnancy.

Medication abortion now accounts for more than half of all abortions in the U.S., according to the Guttmacher Institute.

In December 2021, the FDA announced it permanently lifted its restriction that abortion pills had to be dispensed in-person. In January, it went further by allowing retail pharmacies to provide the drug too, either by mail or in person, so long as they meet certain requirements.

“It’s a very safe medication and it’s highly effective in optimizing treatment of medical abortion, but also miscarriage management as well as helping improve outcomes with induction of labor for fetal demise,” Haider said. “All of these usages have been studied extensively from a safety standpoint, efficacy standpoint, patient acceptability standpoint, patient experience standpoint, et cetera.”

However, Alliance Defending Freedom, a Christian conservative legal advocacy group — the plaintiff that the Texas judge ruled in favor of — claims mifepristone is not safe and that the FDA didn’t study it closely enough before it was approved.

Haider said she and her colleagues will continue to prescribe mifepristone over the next week for medical abortion and miscarriage care and encourages patients who are planning to receive the drugs to get them.

At the end of the week, they will analyze to see if they can keep using the drugs or not.

Misoprostol would still be available for both abortions and miscarriages on its own, but as an off-label use.

Data from around the world shows misoprostol is safe and effective — and that they’re ready to provide misoprostol-only abortions — but that the two-dose regimen is more effective and has fewer side effects.

When given alone to induce an abortion, patients need to take three to four doses of misoprostol about three hours apart.

“We can provide this, we will provide it if needed, we will just have to do a lot of a lot more counseling and support for the patients to go through it in this way, and just really prepare them for the scenarios where the side effects might experience that higher side effects,” Haider said. ‘In my career — I’ve been practicing for over 20 years — and never had to go to this route of medication abortion, so it’s going to be a new experience for our patients and providers.”

It’s unclear how the ruling will affect clinicians and companies that are currently able to send abortion pills through the mail.

If mifepristone does end up being restricted, Haider said clinical care teams, platforms and groups that currently mail mifepristone will likely not continue to do so, therefore patients need to be careful that they’re not being duped by receiving bogus pills.

‘Using a trusted resource would be really important,” she said. “I think patients just asking questions of whoever they are utilizing for these medications. It’s just being aware of where they’re getting it.”

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