A recent comprehensive study has discredited former U.S. President Donald Trump’s claims regarding the use of paracetamol during pregnancy and its supposed link to autism in children. This significant research, published in The Lancet Obstetrics, Gynaecology & Women’s Health, is set to alleviate concerns for expectant mothers who may require these common pain relievers.
In 2022, Trump cautioned pregnant women against the use of Tylenol—the American brand name for paracetamol—asserting that its consumption could lead to a heightened risk of autism. This statement was influenced by the MAHA (Make America Healthy Again) initiative spearheaded by U.S. Health Secretary Robert F. Kennedy Jr. The assertion has caused division among politicians and health professionals across the U.S. and Europe, leading to confusion among the public.
Study findings and implications
Despite the U.S. Food and Drug Administration (FDA) issuing a new safety warning for Tylenol packaging, the European Medicines Agency (EMA) previously stated that there was no scientific evidence connecting paracetamol use during pregnancy to autism. Medical experts have expressed concern that pregnant women might be left without effective treatments for fever or pain, potentially facing stigma due to rising autism rates in recent years.
“We found no clinically important increase in the risk of autism, [attention deficit hyperactivity disorder (ADHD)] or intellectual disability of the children where the mothers took paracetamol during pregnancy,” stated Asma Khalil, a consultant obstetrician and fetal medicine expert at St George’s Hospital in London and lead author of the study.
Khalil emphasized that “the important message to the millions of pregnant individuals is the fact that actually paracetamol is safe to use in pregnancy.” She reiterated that it should remain the preferred option for treating pain or fever in expecting mothers.
Methodology and previous studies
Earlier research had indicated possible connections between paracetamol use during pregnancy and minor increases in the risks of autism and ADHD. However, the researchers at The Lancet pointed out that many of these studies were subject to biases. For instance, a U.S. study cited by the administration last summer suggested a correlation between paracetamol and neurodevelopmental disorders, but Khalil noted that these studies were flawed and susceptible to bias.
The evidence review conducted by The Lancet focused on the most rigorous studies, those with low bias risk, sibling comparisons, and follow-ups extending over five years. Remarkably, this review uncovered no verifiable links between paracetamol and adverse outcomes.
Sibling-comparison studies are particularly insightful, as they enable researchers to observe children from the same mother, who had taken paracetamol only during one pregnancy. This approach accounts for shared genetic and familial factors.
Khalil concluded, “Our findings suggest that previously reported links are likely to be explained by genetic predisposition or other maternal factors such as fever or underlying pain, rather than a direct effect of the paracetamol itself.”
Public health experts, along with the EMA and the European Commission, have countered Trump’s claims, reinforcing that no evidence exists to substantiate them. Grainne McAlonan, a professor of translational neuroscience at King’s College London, remarked, “While the impact of last year’s announcement has been extensive, I hope the findings of this study bring the matter to a close.” She added, “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.”