Government will conduct abortion pill review amid studies showing possible dangers

A top official at the U.S. Food and Drug Administration (FDA) confirmed on Monday that the organization will conduct a review of the abortion drug mifepristone following several recent studies challenging the safety of the drug.

FDA Commissioner Marty Makary said he is “committed” to conducting the review in a June 2 letter addressed to Missouri Sen. Josh Hawley, who has been an outspoken advocate for reviewing abortion pill safety regulations. 

“As with all drugs, FDA continues to closely monitor the post-marketing safety data on mifepristone for the medical termination of early pregnancy,” Makary wrote.

Makary noted that he is “committed to conducting a review of mifepristone and working with the professional career scientists at the agency who review this data.” 

The letter follows a pledge by U.S. Secretary of Health and Human Services Robert Kennedy Jr., who said in a hearing last month that he had instructed Makary to do a “complete review” of the abortion pill following a report showing that more than 1 in 10 women experience adverse side effects from chemical abortions.   

The first-of-its-kind study, published by the Ethics and Public Policy Center on April 28, delved into public health insurance records, finding that about 11% of women suffer at least one “serious adverse event” within 45 days of taking mifepristone for an abortion.

Of 865,727 patients between 2017 and 2023, the study found that more than 4.7% were forced to visit an emergency room related to the abortion, more than 3.3% suffered hemorrhaging, and more than 1.3% got an infection. 

Thousands were hospitalized, more than 1,000 needed blood transfusions, and hundreds suffered from sepsis. Nearly 2,000 had a different life-threatening adverse event.

Kristan Hawkins, president of Students for Life of American and Students for Life Action, celebrated the confirmation of the review, saying: “It’s in writing.” 

“Time to review, reinstate basic safety protocols to save women, and pull from the market to save hundreds of thousands of lives!” she said in a post on X.

Susan B. Anthony Pro-Life America’s Director of Legal Affairs and Policy Counsel Katie Glenn Daniel celebrated the confirmation, sharing her gratitude “for Sen. Hawley’s leadership to secure the FDA’s commitment to fully review the safety of abortion drugs.” 

“We’re encouraged to see the FDA reexamine the data under new leadership after the Biden administration recklessly fueled an unregulated drug market by stripping away in-person dispensing requirements,” Glenn Daniel told CNA. 

Glenn Daniel highlighted a recent peer-reviewed study by the Charlotte Lozier Institute that challenged the abortion industry’s claim that medication abortion is “safer than Tylenol.”

“While the abortion industry and Democrat politicians push the debunked claim that these drugs are ‘safer than Tylenol,’ growing evidence shows they’re far more dangerous than advertised,” she said.  

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