Lancet research involving over 400,000 children finds no link between pregnancy painkiller and developmental issues
A cloud of anxiety that has loomed over expectant mothers for years may finally be lifting. The question of whether paracetamol, one of the most commonly used medications during pregnancy, could harm unborn children has sparked heated debate across medical communities worldwide. That debate reached a fever pitch last year when former US President Donald Trump publicly warned pregnant women to fight like hell to avoid taking the painkiller, claiming links to autism.
His controversial statements, delivered from the Oval Office in September 2025, sent shockwaves through the medical establishment and left countless pregnant women confused and frightened about managing pain and fever. Now, a comprehensive study published in The Lancet Obstetrics, Gynaecology and Women’s Health delivers what researchers are calling the most definitive answer yet.
The research analyzed evidence from 43 previous studies and examined data from more than 400,000 children. The conclusion was unequivocal: paracetamol use during pregnancy does not increase the risk of autism, ADHD or intellectual disability in children.
Groundbreaking methodology
What distinguishes this research from earlier studies is its rigorous approach. Led by researchers from City St George’s, University of London, the team focused on sibling-comparison studies, a powerful design that compares siblings born to the same mother where one pregnancy involved paracetamol use and another did not. This methodology helps control for shared genetics, family environment and long-term parental factors that can skew results in conventional observational studies.
The dataset was extensive, with 262,852 children assessed for autism, 335,255 children assessed for ADHD and 406,681 children assessed for intellectual disability. Across all these outcomes, the conclusion remained consistent: no increased risk linked to paracetamol exposure during pregnancy.
Professor Asma Khalil, professor of obstetrics and maternal fetal medicine at City St George’s, University of London, explained that earlier associations were likely driven by genetic factors or maternal illness rather than paracetamol use itself. Once sibling comparisons were factored in, the apparent risks disappeared.
Addressing confounding factors
Earlier studies that raised alarms often failed to account for critical confounders, including maternal illness and genetic predisposition. Conditions such as fever, infection or chronic pain are common reasons for taking paracetamol and are themselves known to influence pregnancy outcomes. Without accounting for these factors, previous research may have wrongly attributed risk to the medication rather than the underlying illness.
All included studies were assessed using the Quality In Prognosis Studies tool, which evaluates how research design and execution may influence results. The review excluded lower-quality studies where no account was taken of important differences between mothers who use or don’t use paracetamol during pregnancy.
Medical community responds
Medical experts not involved in the research have welcomed the study’s findings. Professor Grainne McAlonnan from King’s College London said expectant mothers do not need the stress of questioning whether medicine most commonly used for a headache could have far-reaching effects on their child’s health.
Professor Ian Douglas from the London School of Hygiene and Tropical Medicine called the review well-conducted, while Professor Jan Haavik from the University of Bergen said the study provides strong evidence that should effectively put this question to rest.
Indian obstetricians echoed these sentiments. Doctor Surbhi Siddhartha, consultant obstetrician and gynecologist at Motherhood Hospital in Kharghar, noted that paracetamol has been used safely in pregnancy for decades and remains the safest painkiller prescribed to expecting mothers.
US maintains caution
Despite the compelling evidence, US health officials maintain that many experts have expressed concern over paracetamol use during pregnancy. The US Food and Drug Administration issued a letter to clinicians urging caution, while also acknowledging it remains the only drug approved for treating fevers during pregnancy. On its website, the FDA states that a causal relationship between the drug and neurological conditions has not been established.
Paracetamol remains the first-line medication recommended globally for pain and fever during pregnancy, largely because alternatives carry clearer safety concerns. Researchers caution that fear-driven avoidance could expose both mother and baby to known risks, particularly when fever is left untreated.
Story credit: BBC