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President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. held a press conference in which they announced a link between acetaminophen use by pregnant women and autism in children.
Acetaminophen is the main ingredient in Tylenol and is the only over-the-counter medication considered safe for treating fever during pregnancy, HHS said. Maternal fever itself carries risks, the agency said, including neural tube defects and preterm birth.
The Food and Drug Administration will begin notifying physicians of its recommendation that pregnant women avoid taking Tylenol during pregnancy unless absolutely necessary. Also, the FDA will be updating the label for acetaminophen to show the risk.
WHY THIS MATTERS
HHS said evidence does not definitively establish causality, but the consistent associations raise concern.
When used short-term and at appropriate dosages, acetaminophen remains widely regarded as safe, HHS said. However, unresolved questions remain regarding chronic or late-pregnancy exposure, the agency said.
Because acetaminophen is one of the most commonly used medications taken during pregnancy, even a modest increase in risk could have a significant public health impact, it said.
The White House also said leucovorin was a promising treatment for symptoms of autism.
The announcement drew anger and concern from the Autism Science Foundation.
“Any association between acetaminophen and autism is based on limited, conflicting, and inconsistent science and is premature,” said Autism Science Foundation Chief Science Officer Dr. Alycia Halladay. “This claim risks undermining public health while also misleading families who deserve clear, factual information. For many years, RFK and President Trump have shared their belief that vaccines cause autism, but this is also not supported by the science, which has shown no relationship between vaccines and autism.”
THE LARGER TREND
Large-scale cohort studies, including the Nurses’ Health Study II and the Boston Birth Cohort, report associations between in utero exposure and later diagnoses of autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD), HHS said. Scientists have proposed biological mechanisms linking prenatal acetaminophen exposure to altered brain development.
Conflicting findings from Scandinavian studies, comparing exposed and unexposed siblings, have not shown significant associations. Critics from Icahn School of Medicine at Mt. Sinai and Harvard argue that statistical adjustments in these analyses may mask true effects, HHS said.
The NIH has launched the Autism Data Science Initiative (ADSI) to strengthen and transform the nation’s autism research portfolio.
One in 31 children born in 2014 were diagnosed with autism spectrum disorder, according to HHS. This is a sharp increase from 1 in 36 just two years earlier.
Email the writer: SMorse@himss.org