The Center is pleased to announce it has awarded a grant to Professor Anick Bérard and a team of epidemiologists, toxicologists, statisticians, and clinical experts in pediatric neurodevelopmental disorders at the Centre Hospitalier Universitaire Sainte-Justine, University of Montreal.

The award is to perform a rigorous systematic review of the literature on developmental outcomes in children born to mothers who used acetaminophen in pregnancy.

This has been an ongoing issue in maternal and child health since some studies began to show that there may be a causal link between acetaminophen use during pregnancy and neurodevelopment disorders, including ADHD and Autism Use Disorders (AUD). At the same time, other studies have not shown such links. 

This led to the issuance of a Consensus Statement published in Nature Endocrinology in 2021 signed by researchers and clinicians warning pregnant women about possible dangers of acetaminophen use. This triggered rebuttals published in the same journal in the following months that were signed by several prominent maternal and child health organizations telling women not to panic but to confer with their healthcare provider before use of the medication (read more here).

In further developments in April of this year, a large study of 2.4 million children in Sweden published in The Journal of the American Medicine Association (JAMA), found no link between acetaminophen use during pregnancy and children’s risk of autism, ADHD, and intellectual disability (read more here).

This well-done study can provide some important information about confounders, especially in the area of family genetics, as there was a large enough group of children born to the same mothers who were followed. But, like all human scientific studies, there are limitations. For example, acetaminophen use was determined from prescriptions and self-report of the mothers and may not be accurate regarding how much was really consumed.  This is mitigated somewhat by the large number of children in the study.

The Center felt that existing research reviews on all sides of the issue are lacking, and therefore put out a call for proposals in late 2023 for a comprehensive systematic review of the existing scientific evidence. The Center then recruited a team of independent expert peer researchers from academia and industry to review all proposals received by the Center. Based on input from this expert panel, the Center selected the research team with the highest scoring proposal to receive the award.  

While the study of Swedish children mentioned above, a collaboration between Drexel University in the U.S. and the Swedish Karolinska Institute funded by the U.S. National Institutes of Health, provides important information and is the most comprehensive look at the issue to date, it cannot settle the issue for anxious mothers experiencing fever and pain during pregnancy or future choices regarding the use of the medication while pregnant.  This new systematic review will add much needed additional knowledge, including study quality assessment and bias analysis.

The Center is committed to scientific transparency in the research it funds. The next step in the process will be the publication of the systematic review protocol, at which time, qualified members of the scientific community will be able to provide comments and suggestions, through the protocol publisher, to the study authors. 

At no time does the Center or its staff become involved in the study design or conduct.

We look forward to the results of the review being published in a high impact scientific journal by the end of this year, providing the field and expectant women a clearer idea of what the science is telling us at this juncture, and what should be the focus of future research on this topic.