On September 22, the FDA issued an alert to physicians nationwide that the use of acetaminophen by pregnant women may be linked to an increased risk of neurological conditions, such as autism and attention-deficit/hyperactivity disorder (ADHD), in their children. The agency also initiated the process for a label change to products containing acetaminophen, most notably Tylenol, which remains the only over-the-counter medication approved for treating fever in pregnancy.
The FDA cited 2 cohort studies in a press release explaining its change in guidance but acknowledged that a “causal relationship has not been established.” Despite this, it suggested that clinicians should consider recommending that their patients minimize the use of the drug for routine, low-grade fever.
The same day, during a press conference, Trump urged pregnant women not to take Tylenol and encouraged them to “tough it out.”
Following these developments, the World Health Organization issued a statement emphasizing that, although extensive research—including large-scale studies—looking into links between acetaminophen use during pregnancy and autism has been undertaken during the past decade, no consistent association has been found.
The study published in JAMA in April 2024 is among the most recent to investigate this question. In it, researchers followed up 2.5 million children born in Sweden between 1995 and 2019 for more than 2 decades. Using sibling controls to account for genetic and other environmental cofounding factors, they found no increased risk in autism, ADHD, or intellectual disabilities in the children of women who used acetaminophen during pregnancy.
To provide clarity on this issue, JAMA Deputy Editor Linda Brubaker, MD, MS, an obstetrician-gynecologist, spoke with the study’s senior author, Brian Lee, PhD, a professor of epidemiology at Drexel University Dornsife School of Public Health. They discussed the study’s methods and findings, the importance of scientific rigor in investigating these questions, and the potential effects on patient care that come with discouraging acetaminophen use during pregnancy.
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