Amna Nawaz
@PBSNewsHour·5.3M subscribers·62.2K videos
FDA head explains decision to drop 'black box' warnings from menopause hormone treatment
Posted
November 10, 2025
Views
9,796
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144
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November 10, 2025
9,796
144
1.47%
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9:18Now PlayingThe FDA announced it would begin asking drug companies to remove so-called “black box” warnings for hormones prescribed to treat symptoms of menopause. The FDA says the warning has dissuaded generations of women from taking advantage of the medication that could help them. Ali Rogin discussed more with FDA Commissioner Dr. Marty Makary.
Editor’s note: In this interview, Dr. Marty Makary said that Harvard School of Public Health Dean Andrea Baccarelli said "there's a causal relationship" between autism and use of acetaminophen during pregnancy.
Baccarelli, who joined Harvard in 2024, did previously offer the opinion that “there is a causal relationship between prenatal acetaminophen use and the NDDs of ADHD and ASD and the related symptomology.” At the time, Baccarelli was an expert witness for plaintiffs in litigation against the maker of Tylenol in 2023.
The judge in that case dismissed Baccarelli’s testimony, writing that it “does not reflect a reliable application of scientific methods.”
In September 2025, following this reporter’s request for clarification as to what Baccarelli had said about the causal relationship between prenatal acetaminophen use and autism, Harvard’s T.H. Chan School of Public Health sent a statement in his name. The statement was also shared with the White House before their announcement on Tylenol. In that statement, Baccarelli wrote that biological evidence from animal studies “lends support to the possibility of a causal relationship between prenatal acetaminophen exposure and neurodevelopmental disorders, including autism. Further research is needed to confirm the association and determine causality.”
He also wrote, “I discussed our scientific findings and this recommendation from our review article with Health and Human Services Secretary Robert F. Kennedy Jr. and NIH Director Jay Bhattacharya in recent weeks and appreciate their interest in this study.”
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