Healthcare (Commonwealth Union) – The Food and Drug Administration (FDA) of the US has initiated steps to revise the labeling of acetaminophen products, including Tylenol, in light of studies indicating a possible link between prenatal exposure and increased rates of neurological disorders such as autism and attention deficit hyperactivity disorder (ADHD) in children. The agency has also issued a nationwide advisory to healthcare providers.
“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” explained the FDA Commissioner Marty Makary, M.D., M.P.H. “Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.”
In an FDA statement it was mentioned that recent findings have pointed to a possible link between acetaminophen use during pregnancy and later diagnoses of conditions such as autism and ADHD. Several large-scale cohort studies, including the Nurses’ Health Study II and the Boston Birth Cohort, have reported this association. Some research indicates that the potential risk may be highest when acetaminophen is used repeatedly or throughout the entire pregnancy.
The FDA further indicated however, it is important to emphasize that although many studies have identified an association, no direct cause-and-effect relationship has been proven, and some studies present conflicting evidence. Acetaminophen also remains the only over-the-counter medication considered safe for managing fever during pregnancy, and untreated high fevers in expectant mothers can pose risks to the fetus.
A new study suggests that when expectant mothers use acetaminophen—commonly known as Tylenol or paracetamol—their children may face a greater likelihood of developing neurodevelopmental disorders (NDDs) such as autism and ADHD.
The findings, released on August 14 in BMC Environmental Health, list Andrea Baccarelli, dean of the faculty at Harvard T.H. Chan School of Public Health and professor of environmental health, as the senior author. The research was spearheaded by the Icahn School of Medicine at Mount Sinai, with contributions from multiple collaborating institutions.
To reach their conclusions, the team reviewed 46 previously published studies from around the world that examined potential links between acetaminophen use during pregnancy and NDDs in children. Using the Navigation Guide Systematic Review approach—a leading method for compiling and evaluating environmental health research—they conducted a detailed and methodical assessment. Their analysis strengthened the evidence pointing to an association between prenatal exposure to acetaminophen and a higher risk of NDDs.
At the same time, the authors cautioned that acetaminophen plays a critical role in managing pain and fever in pregnancy—conditions that, if left untreated, can also endanger fetal development. The researchers stated that their recommendation are careful, case-by-case use of acetaminophen—always the lowest necessary dose for the shortest possible time and under medical supervision—rather than imposing sweeping restrictions.
At the end of September, the FDA revealed plans to send a letter to healthcare providers, advising caution regarding acetaminophen use during pregnancy. According to Baccarelli, he had spoken with Health and Human Services Secretary Robert F. Kennedy Jr. in the weeks before the announcement and shared a statement with the White House, emphasizing that his research identified “evidence of a link” between prenatal acetaminophen exposure and neurodevelopmental disorders. he had pointed out that this link appears strongest when the medication is taken for four weeks or longer.
The statement had further indicated that more studies are required in verifying the link and to establish causation, but given the current data, he believes it is appropriate to be cautious about acetaminophen during pregnancy—particularly in cases of frequent or extended use.
