In a major announcement on Monday, September 22, 2025, the U.S. Food and Drug Administration (FDA) initiated the process of adding an updated warning to the labels of Tylenol and other acetaminophen products to reflect growing body of evidence reflecting an increased risk of neurodevelopmental disorders in children if an expecting mother uses acetaminophen during her pregnancy. Pointing to various cohort studies and research, including some that date back to 2013, the announcement mostly focused on autism and ADHD rates among children born to mothers who used acetaminophen “chronically throughout pregnancy.” The FDA also issued a letter alerting physicians nationwide about this evidence, encouraging them to consider minimizing the use of Tylenol/acetaminophen during pregnancy when not medically indicated in the interest of patient safety.
While this announcement has sparked immediate debate and controversy, our trial attorneys and scientists at Kershaw Talley Barlow encourage our clients, the public, our legal and scientific colleagues, and the medical and scientific community abroad to objectively review the evidence themselves (and in consultation with their physicians) to make an informed decision about the use of Tylenol/acetaminophen during pregnancy based on the scientific data. For historical perspective as to other injuries acetaminophen might cause , the FDA updated the Tylenol/acetaminophen label in 2009 and 2011 to reflect growing evidence that this drug can cause liver injury, a finding that reasonable scientists debated at that time (in 2009), but which is generally and universally recognized today. Moreover, the FDA has already determined that other pharmaceutical products can cause the type of neurodevelopmental injury it now suspects is possible through potential overuse of acetaminophen during pregnancy. For example, Depakote/valproic acid's label was updated in 2014 to reflect an in utero autism risk after growing evidence in the preceding few years.
