What is mifepristone? Judge suspends FDA approval of abortion pill
A federal judge in Texas ordered Friday a pause on U.S. approval of the abortion medication mifepristone, raising new questions about getting access to the most common method of abortion in a ruling that waved aside decades of scientific approval.
The immediate impact of the ruling by U.S. District Judge Matthew J. Kacsmaryk, which does not go into immediate effect, is unclear.
The Biden administration on Thursday said it will ask the Supreme Court to intervene so people can continue to have expanded access to mifepristone. The announcement came after a lower court allowed mifepristone to remain available in the United States, but reimposed previous rules on obtaining and using the drug.
What is mifepristone? How does mifepristone work in the body?
Mifepristone is used with another medication called misoprostol to end a pregnancy that is less than 70 days developed. The pills are taken about two days apart.
Mifepristone stops the “supply of hormones that maintains the interior of the uterus. Without these hormones, the uterus cannot support the pregnancy and the contents of the uterus are expelled,” according to the Mayo Clinic.
The abortion drug has been used in the United States since 2000 and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.
What happens next to medication abortions?
Kacsmaryk, a Trump administration appointee based in Amarillo, Texas, signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues.
The judge's 67-page order gave the government seven days to appeal.
Federal lawyers representing the FDA are expected to swiftly appeal.
Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol.
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How do I get mifepristone and misoprostol?
The medicine must be prescribed by a doctor. It is not available over-the-counter in pharmacies or other stores, though in some places only a telemedicine visit is required to get mifepristone and misoprostol. It is sold under the brand name Korlym or Mifeprex, according to the Mayo Clinic.
Though the requirements for obtaining the medications have changed frequently in recent years, in December 2021, FDA officials allowed "abortion pills" to be available by mail and prescribed via telehealth medical appointments.
How does mifepristone work?
The medication abortion process starts when a person takes the first pill, mifepristone. Between 24 and 48 hours after, the person takes misoprostol, which typically comes in four tablets.
A patient may either put two in each cheek and let them dissolve, or the pills can be inserted into the vagina. Within a few hours, the misoprostol will cause a person’s cervix to dilate and their uterus to contract, emptying the embryo from the person’s uterus.
Symptoms can include cramping, bleeding, chills, nausea and vomiting. The most significant pain and bleeding will last no longer than one to two hours, and the process is completed within 24 hours, though some bleeding is normal for about two weeks.
Is the abortion pill dangerous?
No, health officials say. When used within the first 10 weeks, mifepristone and misoprostol safely terminated 99.6% of pregnancies with low rates of complications. Abortion by pill is used in about 54% of terminated pregnancies in the U.S., according to data from the Guttmacher Institute.
As of June 30, 2022, there have been "28 reports of deaths in patients associated with mifepristone" since 2000, according to the FDA.
However, health experts advise that "The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient."
How do you pronounce mifepristone?
The drug is pronounced mif-uh-pristone, with the last syllable pronounced like the rock: stone.
Contributing: Associated Press
This article originally appeared on USA TODAY: What is mifepristone? Judge suspends abortion pill across US
