Lancet review finds no pregnancy paracetamol link to neurodevelopmental disorders

A large, pre-registered systematic review and meta-analysis published in The Lancet Obstetrics, Gynaecology, & Women’s Health concluded that maternal paracetamol (acetaminophen) use during pregnancy was not associated with a clinically meaningful increase in risk of autism spectrum disorder, attention-deficit/hyperactivity disorder or intellectual disability in children.

The paper, titled “Prenatal paracetamol exposure and child neurodevelopment: a systematic review and meta-analysis” by Francesco D’Antonio and colleagues, pooled evidence from 43 studies, of which 17 met criteria for combined meta-analysis. The authors prioritized higher-quality designs, giving particular weight to sibling-comparison studies, studies judged to have low risk of bias, and studies with at least five years of follow-up. Several very large population studies from Sweden and Japan contributed to the pooled analyses.

When those higher-quality studies were combined, the meta-analysis found no association between maternal paracetamol use and increased risk of autism, ADHD or intellectual disability in offspring. The authors followed a registered protocol and explicitly sought to control for familial and other confounding factors by emphasizing sibling-design evidence in primary analyses. The null finding held when the pooled estimates emphasized the most rigorous cohorts.

The review arrives amid controversy in recent years over earlier analyses that reported links between prenatal acetaminophen and child neurodevelopmental conditions. A 2025 meta-analysis co-authored by Leonardo Baccarelli reported significant associations, and that paper was later cited by some officials as evidence of a causal relationship. Baccarelli has so far declined to comment on officials’ use of his work and on paid testimony he has given asserting a link.

Experts familiar with the literature framed the Lancet review as a substantial corrective to interpretations that suggested a causal risk from routine paracetamol use in pregnancy. David Mandell, professor of psychiatry at the University of Pennsylvania, said the study’s design and attention to confounding made it “a pretty solid rebuke” of the earlier paper. Grainne McAlonan, professor of translational neuroscience at King’s College London, said the focus on sibling designs and high-quality studies confirmed “there is no relationship between taking paracetamol in pregnancy and a higher likelihood of autism, ADHD or intellectual disabilities in the offspring,” and that expectant mothers “do not need the stress” of questioning routine paracetamol use.

Public health implications are immediate. Major clinical guidelines have long recommended paracetamol as the first-line analgesic and antipyretic in pregnancy because it is generally effective and has a favorable safety profile when used as directed. Discouraging paracetamol use without strong evidence could leave fever or pain untreated, and in some situations fever has been linked with increased risks such as miscarriage, preterm birth or developmental problems.

The review’s authors and clinicians urge balanced communication: pregnant people and their care teams should weigh benefits and risks and avoid overreaction to earlier, lower-quality signals. The paper underscores the importance of study design in maternal-fetal research and the need for clear public messaging to prevent disproportionate anxiety among expectant parents, particularly in communities with limited access to care.

Policymakers and health services now face the task of translating these findings into guidance that protects maternal and fetal health while addressing the misinformation and political commentary that amplified earlier fears. Clinicians say the best current course is to continue recommended practice: use paracetamol when clinically indicated, monitor dosing, and treat fever and pain promptly to avoid preventable harms.