Researchers from the Icahn School of Medicine at Mount Sinai have reported a potential link between prenatal acetaminophen exposure and an increased risk of neurodevelopmental disorders, including autism spectrum disorder and attention-deficit/hyperactivity disorder (ADHD), in children. Their study, published in BMC Environmental Health, used the Navigation Guide methodology to systematically evaluate the scientific literature on this topic.
Acetaminophen, also known as paracetamol outside North America and commonly sold under brand names like Tylenol, is widely used during pregnancy for pain and fever relief. The Mount Sinai-led analysis reviewed 46 studies with data from more than 100,000 participants in several countries. This research challenges previous assumptions about the safety of acetaminophen during pregnancy and highlights the need for caution.
The Navigation Guide Systematic Review methodology provided a framework to assess each study’s risk of bias and the overall strength of evidence. According to Diddier Prada, MD, PhD, Assistant Professor at Icahn School of Medicine at Mount Sinai: “Our findings show that higher-quality studies are more likely to show a link between prenatal acetaminophen exposure and increased risks of autism and ADHD. Given the widespread use of this medication, even a small increase in risk could have major public health implications.”
The paper discusses possible biological mechanisms for this association. Acetaminophen can cross the placenta and may contribute to oxidative stress, disrupt hormones, or cause epigenetic changes affecting fetal brain development.
Although causation has not been established by this study, its findings add weight to concerns over current clinical practices regarding acetaminophen use during pregnancy. The researchers recommend cautious use under medical supervision, updated guidelines that better balance benefits and risks, and further research into safer alternatives for managing pain or fever among pregnant women.
Dr. Prada stated: “Pregnant women should not stop taking medication without consulting their doctors. Untreated pain or fever can also harm the baby. Our study highlights the importance of discussing the safest approach with health care providers and considering non-drug options whenever possible.”
Diagnoses of autism and ADHD have risen globally in recent years; these results may affect future public health policy as well as clinical guidance for expectant mothers. The research team collaborated with colleagues from University of California Los Angeles; University of Massachusetts Lowell; and Harvard T.H. Chan School of Public Health.
Funding was provided by grants from several agencies including the National Cancer Institute (U54CA267776), National Institute of Environmental Health Sciences (R35ES031688), and National Institute on Aging (U01AG088684).
The Icahn School of Medicine at Mount Sinai is recognized for its research programs, educational offerings—including highly competitive degree programs—and extensive graduate medical education system across seven member hospitals within New York City’s Mount Sinai Health System.
