Data shows abortion pill is safer than some common prescription drugs, including penicillin and Viagra

Data analyzed by CNN shows mifepristone, the drug at the center of the Texas medication abortion lawsuit, is even safer than some common, low-risk prescription drugs, including penicillin and Viagra.

There were five deaths associated with mifepristone use for every 1 million people in the US who have used the drug since its approval in 2000, according to the US Food and Drug Administration as of last summer. That’s a death rate of 0.0005%.

Comparatively, the risk of death by penicillin — a common antibiotic used to treat bacterial infections like pneumonia — is four times greater than it is for mifepristone, according to a study on life-threatening allergic reactions. Risk of death by taking Viagra — used to treat erectile dysfunction — is nearly 10 times greater, according to a study cited in the amicus brief filed by the FDA.

“(Mifepristone) has been used for over 20 years by over 5 million people with the capacity to become pregnant,” said Ushma Upadhyay, an associate professor in the department of obstetrics, gynecology and reproductive science at the University of California, San Francisco. “Its safety is very well established.”

The lawsuit, filed by a coalition of anti-abortion national medical associations against the FDA, under the umbrella of the “Alliance for Hippocratic Medicine” and several doctors, sought a number of actions by the court, chief among them an injunction ordering the FDA “to withdraw mifepristone and misoprostol as FDA-approved chemical abortion drugs and to withdraw defendants’ actions to deregulate these chemical abortion drugs.”

“Plaintiffs now ask this court to do what the FDA was and is legally required to do: protect women and girls by holding unlawful, setting aside, and vacating the FDA’s actions to approve chemical abortion drugs and eviscerate crucial safeguards for those who undergo this dangerous drug regimen,” they wrote in their initial complaint.

A federal judge said Friday he will suspend the FDA’s two-decade-old approval of mifepristone, but he is pausing his ruling for seven days so the federal government can appeal.

A federal judge in Texas ruled to suspend the FDA’s approval of a medication abortion pill. He is pausing his ruling for seven days so the federal government can appeal. 

Read the decision here:

US District Judge Matthew Kacsmaryk said that the Food and Drug Administration had “entirely failed to consider an important aspect of the problem by omitting any evaluation of the psychological effects of the drug or an evaluation of the long term-term medical consequences of the drug," referring to mifepristone, the first drug in the medication abortion process.

Kacsmaryk also was critical that the drug was not tested for under-18 girls undergoing reproductive development. 

“But that is not all,” he continued, criticizing how the FDA handled ultrasounds to identify ectopic pregnancy.

A federal judge said he will suspend the FDA’s two-decade-old approval of a medication abortion pill, but he is pausing his ruling for seven days so the federal government can appeal.

CNN is reviewing the judge's 67-page ruling now.

Medication abortion now makes up a majority of abortions obtained in the US. It has become a key focus in the fallout from the overturning Roe v. Wade.

The lawsuit against the FDA, filed by anti-abortion doctors and medical associations, was seeking a preliminary injunction that would require the agency to withdraw or suspend its approval of the drug mifepristone, the first drug in the medication abortion process.

A patient prepares to take mifepristone, the first pill given in a medical abortion, at Women's Reproductive Clinic of New Mexico in Santa Teresa, on January 13. (Evelyn Hockstein/Reuters)

Mifepristone is a drug approved by the US Food and Drug Administration that has been shown to be safe and effective for more than two decades.

The lawsuit from anti-abortion advocates claims that the drug is not safe and that the FDA didn’t study it enough to approve it.

Along with misoprostol, mifepristone is one of the drugs used for an abortion via medication, as opposed to surgery.

Mifepristone is marketed under the brand names Mifeprex and Korlym, and it’s sometimes known as RU 486.

Here are some key things to know:

How mifepristone works: Mifepristone blocks a hormone called progesterone, which helps the body maintain the inside of the uterus so a pregnancy can continue. A healthy uterine lining is what supports a fertilized egg, embryo and fetus.

Without progesterone, the uterus will expel its contents.

Someone having a medication abortion takes mifepristone and then, after 24 to 48 hours, takes misoprostol. That drug helps empty the uterus through heavy bleeding and muscle contractions.

The medications can be taken as soon as someone learns that they are pregnant and up to 70 days or less since the first day of their last period.

This method is effective 99.6% of the time when used to end a pregnancy, studies show.

How safe is mifepristone? Data from hundreds of studies and 23 years of approved use has shown that mifepristone is highly safe and effective, according to 12 of the country’s most respected medical associations, including the American College of Obstetricians and Gynecologists and the American Medical Association, which signed an amicus brief in the Texas case.

This medicine combination for abortion is also available in more than 60 other countries.

Since its approval in the US in 2000, there have been 5 deaths associated with mifepristone for every 1 million people who used it, according to the US Food and Drug Administration. That means the death rate is 0.0005%.

Mifepristone’s safety is on par with those of common over-the-counter pain relievers like ibuprofen and acetaminophen, studies show.

Data analyzed by CNN shows that mifepristone is even safer than some of the most common prescription medications. The risk of death from penicillin, an antibiotic used to treat bacterial infections like pneumonia, for example, is four times greater than it is for mifepristone. The risk of death after taking Viagra – used to treat erectile dysfunction – is nearly 10 times higher.

Side effects of mifepristone: Mifepristone usually doesn’t have many side effects, doctors say, but as with any drug, there can be short-lived ones.

Side effects of mifepristone may include dizziness, weakness, vomiting, headache, diarrhea, nausea, and fever or chills, according to the FDA.

Major adverse events like blood loss, hospitalization or a significant infection are “exceedingly rare,” happening in less than 0.3% of patients, according to the medical associations’ amicus brief.

How often is mifepristone used? The mifepristone-misoprostol combination is the most common abortion method in the US.

Preliminary data published February 2022 from the Guttmacher Institute, a research and policy organization focused on sexual and reproductive health that supports abortion rights, showed that medication abortion accounted for 53% of all abortions in the US.

Read more about the drug here.

US district judge Matthew Kacsmaryk speaks at his nomination hearing on Wednesday, December 13th, 2017, in Washington, DC. (Senate Committee on the Judiciary)

The federal judge overseeing the high-profile challenge to the FDA’s two-decade-old approval of certain drugs used to terminate a pregnancy is a deeply conservative jurist with a proclivity for siding with plaintiffs looking to roll back reproductive and LGBTQ rights or block key Biden administration policies.

US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, was confirmed by a 52-46 Senate vote in 2019.

The FDA case, the biggest abortion-related case since the Supreme Court overturned Roe v. Wade last year, has drawn considerable criticism from abortion rights advocates. But Kacsmaryk himself has also drawn scrutiny for the way he’s handled the matter, with critics taking issue with some highly unusual steps he took to delay making the public aware that a hearing was scheduled in the case for March 15.

Since Kacsmaryk took the bench in 2019, he’s helped make Texas a legal graveyard for policies of President Joe Biden’s administration, largely due to the fact that Texas’ rules for how federal cases are assigned in the state have allowed conservatives to file there strategically, almost guaranteeing their complaints will be before sympathetic judges. Kacsmaryk is assigned every case filed in his division.

In recent comments to The Washington Post, Kacsmaryk’s sister, Jennifer Griffith, detailed her brother’s long history of being anti-abortion and how she believes fate brought the abortion case before him.

“I feel like he was made for this,” Griffith said. “He is exactly where he needs to be.”

The group that brought the medication abortion lawsuit, the Alliance for Hippocratic Medicine, incorporated in Amarillo a few months before they filed the suit, according to documents from the Texas secretary of state’s office.

Kacsmaryk is the only federal district judge seated in the Amarillo division of the US District of Northern Texas.

Read more about Kacsmaryk here.