A federal judge based in Texas issued a primary injunction last week that threatens to ban or significantly limit access to the abortion pill, mifepristone, nationwide.
The drug, also known by the brand name Mifeprex, is one of two drugs routinely used in medication abortions in the U.S. But it's also used to manage other conditions in reproductive health, experts say, and losing access to mifepristone could drastically change that care, as well.
Mifeprex was approved by the U.S. Food and Drug Administration in 2000 to end early-stage pregnancies, in combination with another drug, misoprostol. Doctors also sometimes prescribe mifepristone off-label to help move along an early miscarriage and to aid in the process of ending second-trimester pregnancies. If the original Texas ruling goes through and the FDA approval for mifepristone is suspended, the medication would likely not be available for any of these uses, experts say.
Mifepristone, along with misoprostol, “is the gold standard of care for medication abortion,” Dr. Monica V. Dragoman, system director of the complex family planning division in the Raquel and Jaime Gilinski Department of Obstetrics, Gynecology and Reproductive Science at Mount Sinai, tells TODAY.com.
The medication is also “integral to providing high quality, evidence-based services for folks who are facing a variety of obstetrical or gynecological conditions,” she says. Losing access to mifepristone would cause harm to "patients seeking basic health care and undermine the physician-patient relationship," she adds.
Is mifepristone still legal?
Yes. As of this writing, the ability to access mifepristone for abortions has not changed in the U.S. On April 14, the Supreme Court put on hold the full decision by the federal judge in Texas, allowing access to mifepristone to continue unchanged at least until midnight E.T. on April 19, giving "the justices time to consider what next steps to take," NBC News reported.
Originally, the Texas injunction was set to go into effect on Friday, April 14, at midnight C.T. This ruling would have suspended the Food and Drug Administration's 2000 approval of mifepristone for medication abortion. But early Thursday, April 13, the U.S. 5th Circuit Court of Appeals partially blocked the injunction, allowing people to keep accessing mifepristone — but only through week seven of gestation and in person (not online or by mail), with other certain restrictions in place, NBC News reported.
While the Texas ruling impacts the entire country, a separate — and conflicting — ruling from a federal judge in Washington state could preserve access to mifepristone in 17 states and the District of Columbia.
On Thursday, April 13, U.S. Attorney General Merrick Garland said the Justice Department "strongly disagrees" with the 5th Circuit's decision. Both the Justice Department and Danco Laboratories, the makers of Mifeprex, have filed formal appeals with the U.S. Supreme Court seeking to fully block the Texas ruling from going into effect while the lawsuit continues, NBC News reported.
It’s unclear how or when the courts will ultimately resolve this situation — and the inconsistencies between the Texas and Washington rulings. For now, the administrative stay will keep the status quo in place for a little while longer.
Mifepristone for medication abortion
The standard protocol for medication abortion through 10 weeks of pregnancy is to take mifepristone followed by another medication, misoprostol.
Mifepristone works by binding to and blocking receptors of progesterone, a sex hormone involved in pregnancy and the menstrual cycle, Dr. Daniel Grossman, director of Advancing New Standards in Reproductive Health at the University of California, San Francisco, tells TODAY.com.
That means that mifepristone effectively stops the effects of the progesterone in the uterus and the cervix, Dragoman says, which prevents the pregnancy from continuing to grow and helps the pregnancy separate from the uterine wall.
Mifepristone also helps soften the cervix and "prime" the uterus, Dragoman explains. That way, when the misoprostol stimulates contractions, the two medications "work in conjunction to help effectively and safely expel the pregnancy from the uterus through the first trimester."
Serious health risks associated with mifepristone and medication abortion are "incredibly rare," Dragoman says.
The vast majority of people who take mifepristone for an abortion "have a successful experience," especially if they're given proper education about the medication, take the medication as directed and have the usual follow-up a week or two later, she adds.
Cramping is a known side effect of the process. And if patients don't have proper pain management plan, that can lead to a call to their doctor or even an ER visit, Dragoman says. "But those are uncommon and also not life-threatening."
People also frequently experience bleeding, which is another normal part of undergoing a medication abortion, as well as a procedural abortion.
"Anyone who has a successful medication abortion will usually have some bleeding and some cramping with the treatment," Grossman says. "In some ways, those are signs that the medication is working."
Other common side effects of mifepristone can include nausea, headache, diarrhea, dizziness, fever, chills and vomiting, according to the Mifeprex medication guide. There are certain people who shouldn't take mifepristone for safety reasons, including people with bleeding disorders and those who take blood thinners, the FDA says.
In some cases, patients may have severe bleeding or not fully pass the pregnancy, Dragoman says. And those complications "frequently can be treated by a trusted health care provider in their office." It is possible to develop severe, life-threatening bleeding or an infection, but those complications are "exceedingly rare," Dragoman says.
Other mifepristone uses in reproductive care
In the event of an early pregnancy loss, doctors and their patients may decide to follow an expectant management plan, in which they wait for the patient to pass the pregnancy tissue naturally.
Or, in some cases, they may opt for medical management, which is typically performed with mifepristone followed by misoprostol, Grossman says. As in a medication abortion, mifepristone in the context of medical management of miscarriage can help separate the pregnancy "from its place of implantation in the uterine wall," Dragoman says.
Medical management helps people pass the tissue faster and increases the likelihood that they'll pass it completely without the need for other procedures, the American College of Obstetricians and Gynecologists explains.
Terminating second-term pregnancy
Mifepristone and misoprostol can be used to prime the cervix before dilation and evacuation, also called a procedural abortion, Grossman says. "The first step is causing the cervix to start to dilate, and mifepristone is one of the medications that's used for that," he says.
Dragoman explains that a second-trimester abortion can be a particularly "complicated and emotion-filled circumstance." That's because, at that point in a pregnancy, abortions are typically performed due to serious complications, like the premature rupture of membranes or fetal demise.
Although misoprostol can be used alone in this context, adding mifepristone can drastically cut the length of time the procedure takes, Dragoman says. Without it, patients will "be subjected to a longer period of treatment because we're not able to access a medication that we know is supremely beneficial," she adds. "So it's pretty awful."
There is some evidence to support the use of mifepristone in managing uterine fibroids, as a form of emergency contraception, and in helping with labor, but those uses aren't common in the U.S., Grossman says.
Although there is good evidence to use mifepristone outside of abortion, those uses "are probably less well known and definitely underutilized," Dragoman says, "because clinicians have more difficulty accessing the medications as a consequence of already-existing, unnecessary restrictions and stigma on the medications being associated with abortion care."
Outside of reproductive care
Another formulation of mifepristone, called Korlym, is used to manage other health conditions, particularly high blood sugar in people with Cushing syndrome, when the body stores too much of the hormone cortisol over time, according to Mayo Clinic.
It's not clear whether or not this medication, which is a higher dose than Mifeprex and is not indicated for use in abortions, would also be threatened by the ongoing litigation. Because Korlym had a separate approval process, "I don't think it will be affected by this ruling," Grossman says.
But there aren't any clear answers. "We're all a little bit in the dark (on this)," Dragoman says. (Corcept Therapeutics, the makers of Korlym, did not respond to TODAY.com requests for comment.)
In the larger picture, the ongoing litigation "creates new threats and a lack of public trust in the existing institutions and structures that we have supporting quality health care," Dragoman says.
And while much of the focus has been on abortion, "it has bigger, broader implications that (could) have other significant impacts on everybody," she says.