Misoprostal: Suspension of mifepristone approval wouldn’t be the end of medication abortion


CNN
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Even if US District Judge Matthew Kacsmaryk’s decision to suspend the US Food and Drug Administration’s approval of mifepristone goes through, there still will be a nonsurgical option for people to manage abortions at home.

In the United States, the so-called abortion pill is actually two medications, mifepristone, sold under the brand names Mifeprex or Korlym, or known as RU-486, and misoprostol, which is taken about 24 to 48 hours later.

The federal judge’s ruling in Texas last week applies only to mifepristone. He delayed his ruling for a week to allow for appeals, but even if the ruling is put in place, it does not involve misoprostol.

Misoprostol alone is considered a safe and effective way to have an abortion, studies show. It has been used that way for decades.

The two drugs work differently. Mifepristone blocks a hormone called progesterone, which the body needs for the pregnancy to continue. The hormone helps maintain the inside of the uterus, and without it, the uterus will expel its contents.

Misoprostol is approved by the FDA to prevent and treat gastric ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). It also is used off-label for other kinds of ulcers, and it has several gynecological uses, including to induce contractions, to decrease blood loss after delivery and to treat miscarriages.

When used for an abortion, misoprostol works to help empty the uterus through bleeding and muscle contractions.

“It’s a little old-school, but we could do it,” said Dr. Kristyn Brandi, an ob/gyn and abortion provider in New Jersey and a spokesperson for the American College of Obstetricians and Gynecologists.

It’s what people did before the FDA approved mifepristone in 2000, Brandi said.

“Many places around the country that don’t have access to mifepristone, often due to politics, have been using misoprostol-only regimens for a long time,” she said.

California said Monday that it is stockpiling misoprostol.

“While California still believes Mifepristone is central to the preferred regimen for medication abortion, the State negotiated and purchased an emergency stockpile of Misoprostol in anticipation of Friday’s ruling by far-right federal judge Matthew Kacsmaryk to ensure that California remains a safe haven for safe, affordable, and accessible reproductive care,” Gov. Gavin Newsom’s office said in a release.

Some health organizations such as Carafem, a national provider of reproductive health services, offer the one drug alone. It is endorsed as a medically acceptable approach by the World Health Organization. The American College of Obstetricians and Gynecologists says a misoprostol-only regimen is an “acceptable alternative” if mifepristone is unavailable.

The two-drug approach to medicine abortion is preferable because it is slightly more effective, Brandi said. Also, abortion with misoprostol alone can come with more side effects.

A person who uses this method is instructed to use it sublingually, putting four pills under their tongue and leaving them there for 30 minutes, then swallowing what’s left with water. They can also be used vaginally.

Typically, bleeding will begin within one to four hours after the first dose. Heavy bleeding usually lasts about three to five hours, but bleeding can last two weeks or longer, studies show.

Without mifepristone, a person most likely has to take more misoprostol than they would with the two-drug regimen. One study suggested that a person should be prescribed three or four doses as well as an additional dose in case it is needed.

“The more we give, the more side effects people will have. And that’s not the goal. We want to make sure people not only have an effective response to the medicine, we also want to make sure that people aren’t as uncomfortable as they could be,” Brandi said. “Like I tell my patients, you do not need to suffer to have an abortion. That is not the purpose of this process.”

Other side effects can include fever, chills, nausea and diarrhea.

Medication abortion now accounts for more than half of all US abortions, studies show. Even if mifepristone is no longer available and misoprostol becomes the only option, it will still be the most popular choice, according to Dr. Jamila Perritt, an ob/gyn and abortion provider in Washington, D.C.

“Again, it is safe. It is effective. It requires a different dosing, and you experience the symptoms a little bit longer,” Perritt said. “There are some other some additional side effects, like a longer duration of bleeding or more intense nausea or vomiting or gastrointestinal side effects, but when you look at that against the barriers that are put in place, both at the state and now the federal level for accessing abortion, many individuals still choose the second medication alone, because it is more convenient and easier, and it means you’re not walking through hundreds of protesters when you go to get care at your health care provider’s office.”

Dr. Iffath A. Hoskins, president of the American College of Obstetricians and Gynecologists, says that although the one-drug option is safe, people shouldn’t have to make that choice because a lot of research shows that the two drugs in combination are highly safe and effective.

“We do use off label medications when clinically appropriate; however, that should not happen here because we have over two decades worth of clinically sound evidence based information that this is valid option,” Hoskins said.