Psychiatrist.comMaternal Use of Acetaminophen (Paracetamol) During Pregnancy and Neurodevelopmental Disorders in Offspring: A Reasoned Evaluation of Risk

US Administration declared gestational acetaminophen exposure a risk factor for autism and ADHD despite evidence showing absolute risk increases of only 0.09% for ASD at age 10—and sibling analyses finding no association after controlling for shared genetics and environment.

⚖️ PROFESSIONAL IMPACT

• FDA authorization process initiated for label change despite own letter stating “cause-effect relationship has not been established” and acknowledging acetaminophen as safest analgesic option
• Swedish study (2.5 million children) found gestational acetaminophen associated with ASD/ADHD—but aspirin, NSAIDs, opioids also showed identical risks, suggesting pain/inflammation drives risk, not drug exposure
• Sibling analyses in both Swedish and Japanese studies showed zero association between acetaminophen exposure and NDDs when controlling for shared genetic/environmental factors
• Hazard ratios remained minimal (1.05-1.07 range) in fully adjusted analyses with E-values of 1.16-1.28, meaning weak unmeasured confounds could nullify findings

🎯 ACTION ITEMS

• Document that acetaminophen remains FDA-acknowledged safest analgesic/antipyretic during pregnancy despite label change process
• Counsel patients that absolute risk increase is 1 in 1,100 for ASD, with no proven causation and likely confounding by genetics/inflammation
• Explain that avoiding acetaminophen leaves untreated pain/fever (also NDD risk factors) or forces switch to less safe alternatives
• Emphasize shared decision-making without guilting—paternal acetaminophen use and maternal use outside pregnancy show same associations, suggesting confounding

More on Neurodevelopmental Disorders