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Despite Republican attacks, abortion pill Mifeprex is not dangerous

20 Republican senators are trying to convince the FDA that Mifeprex is harmful, but science and history show otherwise.

Despite Republican attacks, abortion pill Mifeprex is not dangerous
[Source images: Pranee Tiangkate/iStock; TylerFairbank/IStock]

Earlier this week, 20 Republican senators sent a letter to the Food and Drug Administration calling medication abortion drug Mifeprex “dangerous” and asking for it to be classified as “an imminent hazard to the public health.” The letter vastly misrepresents the science on Mifeprex, which women can take in combination with another drug to induce an abortion up to 10 weeks after becoming pregnant.

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The letter appears to have been sent in opposition to efforts by Democrats to make mifepristone (the generic name of Mifeprex) more accessible amid the pandemic. Currently, the Food and Drug Administration restricts the conditions under which a patient can access the pill. In order to access a medication abortion, patients have to receive it at a clinic or medical office with a healthcare provider who is registered by the drug manufacturer and who can counsel the patient on the risks associated with the medication. The Democrats are asking for the Risk Evaluation and Mitigation Strategy surrounding Mifeprex to be dropped given the circumstances of the pandemic. Dropping that strategy might allow a woman to speak with a healthcare provider through a virtual visit, have necessary lab work done locally, and then receive their medication through the mail. (This model is the subject of the TelAbortion study, which began in 2016 and looks at whether telehealth should be used in abortion services.) But Republicans have been pushing a different agenda.

Back in March, a group of antiabortion groups sent Health and Human Services chief Alex Azar a letter asking that he essentially shut down abortion clinics in order to preserve personal protective equipment for other medical services. It also asked that he not allow abortion clinics to provide services virtually or to send mifepristone through the mail. The letter requested that clinics provide medically accurate information on the risks of medication abortions.

Both anti-abortion activists and Republican senators have spread the idea that Mifeprex is somehow a risky medication, which is simply not true.

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The FDA first approved mifepristone, the only medication for abortion available in the U.S., in 2000, but it has been used in France since 1988. It also has an incredible track record. At the end of 2018, the FDA reported that among the 3.7 million women who had used mifepristone, only 24 had died. Fourteen of those deaths involved homicide, drug combination intoxication and overdose, substance abuse, methadone overdose, drug intoxication, suspected homicide, suicide, unintentional overdose resulting in liver failure, or emphysema. The other eight women, who died of sepsis, took misoprostol, which is taken vaginally in combination with Mifeprex.

Those eight deaths were the topic of much concern over a decade ago when they happened. It’s not clear exactly what caused them, but in 2006, Planned Parenthood changed its policy around misoprostol: Women were only to take it orally. The organization also decided to give women a preventative course of antibiotics along with it. A 2014 study reveals that in the five years after making that protocol change, infection-related deaths among women who received a medication abortion dropped to zero.

The only other deaths among women who received medication abortions were two ruptured ectopic pregnancies. An ectopic pregnancy is when a fertilized egg implants where it’s not supposed to, often in the fallopian tubes. The condition, which affects approximately 1% to 2% of pregnancies, according to 2012 data from the CDC, can be fatal for women. It represents 3% to 4% of pregnancy-related deaths. Surgical abortion is currently the most common procedure used in the case of ectopic pregnancy as the FDA currently does not allow the use of Mifeprex to treat it. The reason these ruptured ectopic pregnancies show up among fatalities related to mifepristone is likely because doctors didn’t realize that these pregnancies were ectopic. Considering that there have only been two ruptured ectopic pregnancies among 3.7 million women over an 18-year period, it’s clear the screening measures in place are effective. That said, studies show that Mifeprex is also safe for ectopic pregnancies.

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These incredibly low numbers have been declining steadily over the 20 years that Mifeprex has been in use. Between 2012 and 2018, adverse events related to medication abortion have halved; hospitalizations and infections are a third of what they were, according to the FDA. If anything is dangerous to women’s health, it’s living in Arkansas, where nearly 46 women die for every 100,000 children born. It also happens to be one of the states with the most intense restrictions on abortion.

Experts on women’s health say a rash of self-managed abortions may be coming, a phenomenon that may be amplified as certain states clamp down on abortion-care access. While self-managed abortion may be safer than it was in the 1960s, managing an abortion on one’s own has tricky legal implications and could land a woman in jail.

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About the author

Ruth Reader is a writer for Fast Company. She covers the intersection of health and technology.

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