Evidence-Based. Clearly Delivered.
Evidence-Based. Clearly Delivered.
ACOG and SMFM both responded the US Department of Health & Human Services (HHS)/FDA announcement regarding a labeling change for acetaminophen, based on “evidence suggesting that use of acetaminophen by pregnancy women may be associated with an increased risk of neurological conditions such as autism and ADHD in children.” ACOG and SMFM clearly state that there are no high-quality studies demonstrating any causal relationship between acetaminophen and neurodevelopmental disorders in children and both organizations affirm that acetaminophen should be considered safe in pregnancy.
ACOG further points out that quality publications have explored this topic and did not find evidence to support significant risk (to read a summary of the JAMA study, see ‘Related ObG Topics’ below)
In fact, the two highest-quality studies on this subject—one of which was published in JAMA last year—found no significant associations between use of acetaminophen during pregnancy and children’s risk of autism, ADHD, or intellectual disability.
The SMFM statement provides more information regarding risks of not managing fevers in pregnancy
Untreated fever, particularly in the first trimester, increases the risk of miscarriage, birth defects, and premature birth, and untreated pain can lead to maternal depression, anxiety, and high blood pressure
Of note, this concern is not recent and both ACOG and SMFM have responded previously to studies suggesting this association. The SMFM ‘Prenatal Acetaminophen Use and Outcomes in Children’ provides a review regarding the design flaws in these papers and the evidence-based reasoning behind the professional societies’ ongoing guidance regarding the safety of acetaminophen as the antipyretic of choice throughout pregnancy.
Likewise, FIGO provides a literature review, with a particular focus on the paper by Prada et al. (Environmental Health, 2025) that included 46 studies. The Prada study was led by the Icahn School of Medicine at Mount Sinai and the senior author is the dean of faculty at the Harvard TH Chan School of Public Health. The methodology used was a Navigation Guide Systematic Review which synthesizes evidence regarding the health effects of environmental contaminants and other exposures. According the Harvard public health school, the methodology is a “gold-standard framework for synthesizing and evaluating environmental health data” and allowed for a “comprehensive analysis that supported evidence of an association between acetaminophen exposure during pregnancy and increased incidence of NDDs.”
FIGO’s analysis of the Prada study found the following and is keeping with similar concerns voiced by ACOG and SMFM:
Links can be found in ‘Learn More – Primary Sources’ below, including ACOG FAQs.
ACOG Affirms Safety and Benefits of Acetaminophen during Pregnancy
ACOG Practice Advisory: Acetaminophen Use in Pregnancy and Neurodevelopmental Outcomes
SMFM Response to Administration Announcement on Acetaminophen Use During Pregnancy and Autism
ACOG FAQs: Acetaminophen in Pregnancy
ACOG Response to Consensus Statement on Paracetamol Use During Pregnancy
SMFM Statement: Prenatal Acetaminophen Use and Outcomes in Children
MotherToBaby: Acetaminophen (Paracetamol)
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