Q&A: The FDA says the abortion pill mifepristone is safe. Here's the evidence

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Abortion is back connected nan docket astatine nan U.S. Supreme Court, pinch nan justices proceeding arguments Tuesday astir whether a pill utilized to terminate early pregnancies was decently evaluated by nan Food and Drug Administration.

The medication, mifepristone, has been utilized successful nan United States much than 5 cardinal times since it was approved for usage successful 2000, according to Danco Laboratories, nan institution that sells it nether nan marque sanction Mifeprex. Fewer than 0.5% of women who return it acquisition “serious adverse reactions,” and deaths are exceedingly rare, the FDA says successful its prescribing accusation for doctors.

Mifepristone debuted successful France, its location country, and China successful 1988. It is now approved successful 96 countries, from Albania to Zimbabwe, according to Gynuity Health Projects, a nonprofit that advocates for women’s reproductive rights.

Here’s a person look astatine nan information of mifepristone.

What is mifepristone?

Mifepristone is nan generic sanction of a pill that makes up half of nan two-drug regimen utilized successful medicine abortions successful nan United States. When utilized successful conjunction pinch a supplier called misoprostol, it tin terminate a gestation that is successful nan first 10 weeks of gestation.

The synthetic steroid was primitively known arsenic RU-486 (the “RU” stands for Roussel-Uclaf, nan French institution that developed nan pill). It is besides sold nether nan marque sanction Mifeprex.

How does mifepristone work?

It prevents a earthy steroid hormone called progesterone from doing its job, which is to get nan soul lining of nan uterus fresh for an embryo to implant astir a week aliases truthful aft an ovum is fertilized.

Mifepristone gets successful nan measurement of this process by blocking nan receptors that progesterone would usually hindrance with.

How do we cognize it is safe?

As pinch different medications, nan Food and Drug Administration has monitored mifepristone’s information floor plan successful nan decades since it went connected nan market. If problems cropped up that weren’t evident during objective trials, nan agency could person revoked its approval.

Instead, it has expanded entree to mifepristone. For example, it was initially approved for usage during nan first 7 weeks of pregnancy; successful 2016, that model was extended to 10 weeks. Likewise, aft nan COVID-19 pandemic accelerated acceptance of telemedicine, nan FDA successful 2021 stopped requiring patients to spot a healthcare supplier successful personification successful bid to get a mifepristone prescription.

Those 2 decisions are astatine issue successful nan cases going earlier nan court Tuesday.

“Hundreds of aesculapian studies and immense amounts of information person confirmed its information and efficacy arsenic portion of this two-drug regimen,” nan American College of Obstetricians & Gynecologists, nan American Medical Assn., and different aesculapian societies wrote successful a friend-of-the tribunal brief revenge connected behalf of nan FDA and Danco. The little noted that “major adverse events hap successful little than 0.32% of patients” and that “the consequence of decease is almost non-existent.”

Another motion of nan drug’s information is nan truth that medicine abortions person overtaken surgical abortions successful nan United States. Last year, 63% of abortions nationwide were carried retired pinch mifepristone, according to nan Guttmacher Institute, a nonprofit investigation group that supports reproductive rights.

Are location broadside effects to taking mifepristone?

There tin be. According to nan FDA, nan most communal ones see headaches, weakness, dizziness, nausea, vomiting, diarrhea, fever and chills.

The serious broadside effects to watch retired for aft utilizing some narcotics successful nan regimen are dense bleeding (which nan FDA describes arsenic “enough to soak done 2 heavy full-size sanitary pads per hr for 2 consecutive hours”), abdominal pain, a fever supra 100.4 degrees Fahrenheit that lasts for astatine slightest 4 hours, and “feeling sick” much than a time aft taking misoprostol.

Symptoms for illustration these could beryllium signs of a life-threatening infection, an ectopic pregnancy aliases different superior problem. Anyone experiencing them should interaction a healthcare supplier correct away.

Can mifepristone beryllium fatal?

The FDA says it is aware of 32 women who died aft taking mifepristone betwixt September 2000 (when it was first approved successful nan United States) and nan extremity of 2022.

However, it’s not clear that mifepristone was responsible for immoderate of these deaths. Two of them were decidedly caused by ruptured ectopic pregnancies, respective died of supplier intoxication aliases overdoses, and astatine slightest 2 women who took nan pill were victims of homicides, nan FDA said. As for nan remaining cases, patients were taking different medications aliases undergoing treatments astatine nan aforesaid time, making it difficult to pin nan blasted connected mifepristone, according to nan agency.

In their legal brief, nan aesculapian groups said that successful nan worst-case scenario, nan supplier could person caused nary much than 13 of nan 32 deaths. That makes nan supplier little vulnerable than utilizing “Viagra aliases getting one’s contented teeth removed.”

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Source latimes
latimes