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What is mifepristone, the drug at the center of the Texas medical abortion lawsuit?





CNN

The United States Supreme Court stayed a ruling by a federal judge in Texas to discontinue approval of mifepristonea US Food and Drug Administration-approved drug that has been shown to be safe and effective for more than two decades.

Abortion advocates’ lawsuit He claimed that the drug is not safe and that the FDA did not study it enough to approve it.

With misoprostol, mifepristone It is one of the medications used for an abortion through medication, as opposed to surgery.

Mifepristone is marketed under the brand names Mifeprex and Korlym, and is sometimes known as RU 486.

Mifepristone blocks a hormone called progesterone, which helps the body maintain the inside of the uterus so that the pregnancy can continue. A healthy uterine lining is what supports a fertilized egg, embryo, and fetus.

Without progesterone, the uterus will expel its contents.

Someone who has a medical abortion takes mifepristone and then after 24 to 48 hours they take misoprostol. This medication helps empty the uterus through strong bleeding and muscle contractions.

The drugs can be taken as soon as someone finds out they are pregnant and up to 70 days or less from the first day of pregnancy. Last period.

This method is effective 99.6% of the time when used to terminate a pregnancy, studies show.

Data from hundreds of studies and 23 years of approved use have shown that mifepristone is highly sure and cash, according to 12 of the most in the country respected medical associations, including the American College of Obstetricians and Gynecologists and the American Medical Association, which signed an amicus brief in the Texas case.

This combination of abortion medications is also available in over 60 other countries.

Since its approval in the US in 2000, there have been 5 deaths associated with mifepristone for every 1 million people who used it, according to the United States Food and Drug Administration. That means the death rate is 0.0005%.

The safety of mifepristone is on par with that of common over-the-counter pain relievers like ibuprofen and acetaminophen, studies show.

Data reviewed by CNN shows that mifepristone is even safer than some of the most common prescription drugs. The risk of death from penicillin, a antibiotic used to treat bacterial infections such as pneumonia, for example, is four times greater than for mifepristone. The risk of death after taking Viagra, which is used to treat erectile dysfunction, is almost 10 times higher.

Mifepristone usually doesn’t have many side effects, doctors say, but as with any medication, there can be some that are short-lived.

Side effects of mifepristone may include dizziness, weakness, vomiting, headache, diarrhea, nausea, and fever or chills. according to the FDA.

Major adverse events such as blood loss, hospitalization or significant infection are “extremely rare” and occur in less than 0.3% of patients, according to the medical associations amicus report.

The combination of mifepristone and misoprostol is the most common abortion method in the US.

Preliminary data published in February 2022 from the Guttmacher Institutea research and policy organization focused on sexual and reproductive health that supports abortion rights, showed that medical abortion accounted for 53% of all abortions in the US.

Regardless of the status of mifepristone, misoprostol would still be available and could be used only for a medical abortion.

The only use of misoprostol that is FDA approved It is for the prevention and treatment of gastric ulcers. But some doctors use it “off label” only for an abortion; It may also have other off-label obstetric or gynecological uses, such as inducing labor.

Studies show that misoprostol alone is effective and safe for abortion and is a reasonable” option for people wanting a first-trimester abortion, according to a 2019 review of multiple studies, but the two-drug regimen is considered more effective.

This review said that in all studies of people taking misoprostol alone, about 78% had complete miscarriages, and a viable pregnancy was terminated in more than 93% of cases. At most 0.2% of cases had serious complications requiring transfusion or hospitalization.

People who take misoprostol alone for an abortion usually need to take more for it to work, and the side effects it can be more intense, said Dr. Melissa L. Wong, an OB/GYN in Massachusetts and a member of Physicians for Reproductive Health.

“Misoprostol still works very well and is very safe,” Wong said. “Usually, mifeprestone does not cause any side effects as it stops the pregnancy hormone. With misoprostol, some people may tolerate it slightly less due to some side effects such as nausea, vomiting, sometimes diarrhea, or transient fever. Those are still safe and expected side effects, but they are still uncomfortable for anyone.”


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