A systematic review published in The Lancet Obstetrics, Gynaecology, & Women’s Health has provided further robust evidence debunking claims that acetaminophen (paracetamol) use during pregnancy increases the risk of autism spectrum disorder (ASD) and attention-deficit hyperactivity disorder (ADHD).
Testing the hypothesis
By examining a meta-analysis of 43 studies, with a specific focus on sibling comparison, researchers have aimed to isolate the pharmacological effects of the drug from confounding variables such as genetics and environmental factors. The findings indicate that when sibling comparisons were analysed, prenatal acetaminophen exposure showed no significant association with ASD or intellectual disabilities. The additional data cements existing clinical recommendations, giving reassurance that the drug remains the standard of care for pain and fever management during pregnancy when used as directed.
For pharmaceutical stakeholders, the new data comes at a critical juncture following high-profile political pressure in the US to mandate label changes for the drug and provides the industry with a robust scientific evidence base to defend the safety profile and market stability of this cornerstone over-the-counter analgesic.
US backlash
However, the findings have not been without controversy. Critics from the US Department of Health and Human Services have argued that the methodology of the review may be too narrow. Despite this, the authors maintain that their rigorous selection criteria are essential to ensure data integrity.
Co-author, Prof Asma Khalil, Professor of Obstetrics and Maternal-Fetal Medicine, St George’s Hospital, University of London, emphasised the clinical significance of the findings, telling The Guardian: “The message is clear: paracetamol remains a safe option during pregnancy when taken as guided.”
While acknowledging the need for further large-scale sibling studies, the authors concluded: “Current evidence does not indicate a clinically important increase in the likelihood of ASD, ADHD or intellectual disability in children of pregnant individuals who use paracetamol as directed, supporting existing recommendations on its safety.”
