
Acetaminophen (paracetamol), better known by the brand Tylenol, is under the spotlight after President Donald Trump asserted that its use during pregnancy is tied to higher autism risk in children. He added that the Food and Drug Administration (FDA) would move to update warning labels to reflect the “possible association.”
The remarks sparked immediate pushback from scientists, regulators, and medical associations worldwide. The European Medicines Agency (EMA) said there is no robust evidence linking paracetamol use in pregnancy with autism and reaffirmed its safety when used in appropriate doses. The World Health Organization (WHO) and national health agencies echoed the same position, stressing that available studies show no proven causal relationship.
Tylenol’s parent company, Kenvue, also issued a strong rebuttal. Its shares had plunged initially following reports of Trump’s remarks but later rebounded, with investors reassured by both the company’s statement and scientific consensus.
Several large-scale studies, including Swedish cohort analyses, have found no causal link, with researchers warning against drawing conclusions from observational data plagued by confounding variables. A Nature review published earlier this year also deemed the evidence “inconclusive and inconsistent.”
The controversy raises serious questions about public health communication. Even if labels are updated, experts fear misinformation could discourage women from using a widely relied-upon medication, leading to untreated pain or fever during pregnancy—both of which carry their own risks.
The debate now centers on: Will the FDA’s move reshape consumer confidence in Tylenol? And can Kenvue protect its reputation as health authorities scramble to reassure the public?