The FDA says mifepristone is safe. Here's the proof

Abortion is back on the docket at the U.S. Supreme Court as the justices hear arguments Tuesday over whether a pill used to end early pregnancies has been properly reviewed by the Food and Drug Administration.

The drug, mifepristone, has been used more than 5 million times in the United States since it was approved for use in 2000. according to Danco Laboratories, the company that sells it under the brand name Mifeprex. Less than 0.5% of women who use it experience 'serious side effects', and deaths are extremely rare. says the FDA in the prescribing information for doctors.

Mifepristone debuted in 1988 in France, his home country and China. That is the case now approved in 96 countriesfrom Albania to Zimbabwe, according to Gynuity Health Projects, a nonprofit organization that advocates for women's reproductive rights.

Here is a closer look at the safety of mifepristone.

What is mifepristone?

Mifepristone is the generic name of a pill that makes up half the amount two-drug regimen used in medication abortions in the United States. When used in combination with a drug called misoprostol, it can terminate a pregnancy that occurs in the first 10 weeks of pregnancy.

The synthetic steroids was originally known as RU-486 (the “RU” stands for Roussel-Uclaf, the French company that developed the pill). It is also sold under the brand name Mifeprex.

How does mifepristone work?

It prevents a natural steroid hormone called progesterone does not do its job of preparing the inner lining of the uterus for the implantation of an embryo, about a week after an egg has been fertilized.

Mifepristone hinders this process by blocking the receptors to which progesterone would normally bind.

How do we know it's safe?

As with other medications, the Food and Drug Administration has monitored mifepristone's safety profile over the decades since it hit the market. If problems arose that were not apparent during clinical trials, the agency could have withdrawn its approval.

Instead, it is expanded access to mifepristone. For example, it was initially approved for use during the first seven weeks of pregnancy; in 2016, that window was extended to 10 weeks. Similarly, after the COVID-19 pandemic accelerated the adoption of telemedicine, the FDA in 2021 stopped requiring patients to visit a healthcare provider in person to obtain a prescription for mifepristone.

These two decisions are at issue in the cases pending before the court on Tuesday.

“Hundreds of medical studies and vast amounts of data have confirmed its safety and efficacy as part of this two-drug regimen,” said the American College of Obstetricians & Gynecologists, the American Medical Assn. and other medical associations. wrote in a letter from a friend of the court submitted on behalf of the FDA and Danco. The letter noted that “major adverse events occur in less than 0.32% of patients” and that “the risk of death is virtually non-existent.”

Another sign of the drug's safety is the fact that medication abortions have overtaken surgical abortions in the United States. Last year, 63% of abortions nationwide were performed with mifepristone, according to the Guttmacher Institutea non-profit research group that supports reproductive rights.

Are there any side effects to using mifepristone?

There can be. According to the FDA, the most common include headache, weakness, dizziness, nausea, vomiting, diarrhea, fever and chills.

The serious side effects things to watch for after using both medications in the regimen are heavy bleeding (which the FDA describes as “enough to soak two thick, large sanitary napkins per hour for two consecutive hours”), abdominal pain, fever above 100 degrees Fahrenheit that lasts for at least four hours, and that you “feel sick” for more than a day after taking misoprostol.

Such symptoms could be signs of a stroke life-threatening infectionAn Ectopic Pregnancy or other serious problem. Anyone affected should contact a healthcare provider immediately.

Can mifepristone be fatal?

The FDA says it is aware of 32 women who died after taking mifepristone between September 2000 (when it was first approved in the United States) and the end of 2022.

However, it is not clear that mifepristone was responsible for these deaths. Two of them were definitely caused by terminated ectopic pregnancies, several died from drug intoxication or overdoses, and at least two women taking the pill were victims of homicides, the FDA said. As for the remaining cases, patients were taking other medications or undergoing treatments at the same time, making it difficult to pin the blame on mifepristone, according to the agency.

In their legal assignmentthe medical groups said that at worst the drug could have caused no more than 13 of the 32 deaths. That makes the drug less dangerous than using “Viagra or having wisdom teeth removed.”

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