A lawsuit in federal court in Texas could block the use of mifepristone, an FDA-approved drug that has been proven safe and effective for more than two decades.
Lawsuit from anti-abortion advocates Claims that the drug is unsafe and that the FDA has not studied it enough to approve it.
along with Misoprostol, mifepristone Is one of the medicines used for abortions that are done by medicine, not surgery.
Mifepristone is sold under the brand names Mifeprex and Korlym, and is sometimes called RU 486.
Mifepristone blocks a hormone called progesterone that helps the body maintain the inside of the uterus so pregnancy can continue. A healthy endometrium supports fertilized eggs, embryos and fetuses.
Without progesterone, the uterus expels its contents.
Patients with a medical abortion are given mifepristone, followed by misoprostol 24 to 48 hours later. This drug helps empty the uterus through heavy bleeding and muscle contractions.
You can take these medicines as soon as you learn you are pregnant and up to 70 days or less from the first day of pregnancy last term.
When used to terminate pregnancies, this method is effective 99.6% of the time, research shows.
Data from hundreds of studies and 23 years of approved use show that mifepristone is highly safe and valid, according to arrive 12 The country’s most respected Medical societies, including the American College of Obstetricians and Gynecologists and the American Medical Association, signed an amicus brief in the Texas case.
This abortion drug combination also has more than 60 other countries.
Since it was approved in the United States in 2000, mifepristone has accounted for 5 deaths per 1 million people using mifepristone. US Food and Drug Administration. This means a mortality rate of 0.0005%.
Research shows that mifepristone is as safe as common over-the-counter pain relievers like ibuprofen and acetaminophen.
Data analyzed by CNN suggests that mifepristone is even safer than some of the most commonly prescribed drugs. risk of death from penicillin, antibiotic For example, drugs used to treat bacterial infections such as pneumonia are four times bigger instead of mifepristone.Death risk approached after taking Viagra (used to treat erectile dysfunction) 10 times higher.
Mifepristone usually doesn’t have many side effects, but like any drug, there can be short-lived side effects, doctors say.
Mifepristone side effects may include dizziness, weakness, vomiting, headache, diarrhea, nausea, fever or chills, According to FDA.
Major adverse events such as blood loss, hospitalization or serious infection are “extremely rare,” occurring in less than 0.3 percent of patients, according to the Medical Association’s amicus briefing.
The mifepristone-misoprostol combination is the most common abortion method in the United States.
Preliminary figures for February 2022 release from Guttmacher Institutea research and policy organization focused on sexual and reproductive health in support of abortion rights, shows that medical abortion accounts for 53 percent of all abortions in the United States.
If a judge in Texas bans mifepristone, misoprostol will still be available and can be used alone for medical abortion.
The only use of misoprostol is FDA-approved For the prevention and treatment of gastric ulcers. But some doctors use it “off-label” alone for abortions; it can also be used for other off-label obstetrical or gynecological uses, such as inducing labor.
Studies have shown that misoprostol alone is effective and safe for abortion and is a “reasonable” It’s an option for people who want a first-trimester abortion, but a two-drug regimen is thought to be more effective, according to a 2019 review of multiple studies.
In all studies of people taking misoprostol alone, about 78 percent had complete miscarriages, and viable pregnancies were terminated in more than 93 percent of cases, the review said. Serious complications requiring blood transfusion or hospitalization occurred in at most 0.2% of cases.
People who take misoprostol alone for abortion often need to take more doses to work, and the side effects Melissa L. Wong, MD, an ob-gyn in Massachusetts and a fellow of the Society of Physicians for Reproductive Health, said.
“Misoprostol is still very effective and very safe,” Wong said. “Mifepristone usually does not cause any side effects because it blocks the pregnancy hormone. With misoprostol, some people may take it for certain side effects such as nausea, vomiting, and sometimes diarrhea or brief fever. It was slightly less well tolerated. These are still safe and the side effects are to be expected, but still uncomfortable for anyone.”