Prenatal Paracetamol and Autism/ADHD Risk: New Research Findings
- A new systematic review and meta-analysis published in The Lancet Obstetrics, Gynaecology, & Women's Health determined that current evidence does not indicate a clinically vital increase in the...
- This review follows the FDA's proclamation in September 2025 that the label for acetaminophen would be changed to reflect supposed evidence that use by pregnant women may be...
- Along with this announcement, the agency also noted that while studies describe an association between acetaminophen and neurological conditions, a causal relationship has not been established.
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A new systematic review and meta-analysis published in The Lancet Obstetrics, Gynaecology, & Women’s Health determined that current evidence does not indicate a clinically vital increase in the likelihood of autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) in offspring when paracetamol-or acetaminophen (Tylenol; Kenvue) in the US-is used as directed among pregnant individuals.1
FDA Label Update Reflects supposed Effects of Acetaminophen’s Prenatal Use
This review follows the FDA’s proclamation in September 2025 that the label for acetaminophen would be changed to reflect supposed evidence that use by pregnant women may be associated with a heightened risk of neurological conditions, such as ASD and ADHD, in offspring.2
Along with this announcement, the agency also noted that while studies describe an association between acetaminophen and neurological conditions, a causal relationship has not been established. They cautioned that acetaminophen is the only OTC drug approved to treat fe
Prenatal Acetaminophen Use Linked to Neurodevelopmental Risks, FDA Inquiry Reveals
The Food and Drug Administration (FDA) is investigating a potential link between acetaminophen use during pregnancy and an increased risk of autism and other neurodevelopmental issues in children, according to findings published in The Lancet Obstet Gynecol Women’s Health and reported by Pharmacy Times on January 19, 2026.
A systematic review and meta-analysis led by D’Antonio, Flacco, Valle, and colleagues, published in 2026 (DOI: 10.1016/S3050-5038(25)00211-0), examined existing research on prenatal paracetamol exposure and child neurodevelopment. The FDA’s investigation follows these findings, which suggest a possible association, though the agency has not yet established a causal relationship.
according to a September 23, 2025 report in pharmacy Times, the FDA alleges a connection between prenatal acetaminophen use and autism in children. The agency is currently reviewing available data to determine the extent of the risk and whether further regulatory action is necessary.
Further research is ongoing to clarify the potential risks and benefits of acetaminophen use during pregnancy. Pregnant individuals should consult with their healthcare providers before taking any medication.