Comment from Society for Developmental and Behavioral Pediatrics

AnonymousOpposeAdvocacy
Summary: The Society for Developmental and Behavioral Pediatrics opposes the proposed FDA labeling change for over-the-counter acetaminophen. They argue that there is no strong evidence linking appropriate acetaminophen use during pregnancy to an increased risk of autism or ADHD, citing studies that suggest genetics and maternal health are more likely factors.
The Society for Developmental and Behavioral Pediatrics does NOT support an FDA labeling change for over the counter acetaminophen-containing projects, as there is no strong evidence showing a direct relationship between the appropriate use of acetaminophen during pregnancy and increased risk for autism or ADHD. Some recent studies have suggested associations, but these do not prove causation. Importantly, when researchers used more sophisticated study designs that compared siblings within the same family—which better controls for genetic and maternal health factors—any previously observed associations between acetaminophen use and autism and ADHD disappeared (see Ahlqvist VH, et al. JAMA. 2024;331(14):1205-1214. doi:10.1001/jama.2024.3172). This suggests that family genetics and maternal health, rather than acetaminophen itself, may explain earlier findings. Acetaminophen continues to be considered safe when used as directed during pregnancy by the American College of Obstetricians and Gynecologists and other leading medical groups

View on Regulations.gov