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Maternal Use of Acetaminophen During Pregnancy and the Risk of Attention Deficit/Hyperactivity Disorder (ADHD) in Offspring: Developmental Origin of Neurodevelopmental Disorders

Award Number: R01HD122839
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/21/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2030

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Maternal Use of Acetaminophen During Pregnancy and the Risk of Attention Deficit/Hyperactivity Disorder (ADHD) in Offspring: Developmental Origin of Neurodevelopmental Disorders - ABSTRACT Acetaminophen (APAP) is used by about 50% of pregnant women. While APAP currently remains classified as FDA Pregnancy Category B (the same safety rating as multivitamins), the emerging literature linking prenatal use of APAP to increased risk of attention deficit hyperactivity disorder (ADHD) in offspring and the intense public interest in this potential link have raised serious concerns about APAP use in pregnancy and highlighted the urgent need for more research data. It is well known that APAP targets the brain for its therapeutic effects through multiple pathways, thus the reported link is supported by well-established underlying biology and pathogeneses. However, some important limitations in prior studies (e.g., limited ability to identify APAP users among pregnant women, inaccurate diagnosis of ADHD cases, and a lack of control for confounding by indication) have led to inconsistent findings, uncertainties and controversies about the link. Recently, the U.S. government and 91 scientists who published a consensus statement have called for more urgent research to investigate this potentially important link. Leveraging a uniquely available birth cohort of 9,500 mother-child dyads assembled by our team over decades, for which women were interviewed during pregnancy about their prenatal APAP use, we propose to conduct a large longitudinal birth cohort study to investigate the relationship between in-utero APAP exposure and ADHD risk. Taking advantage of our unique data, our study design will address many limitations in prior studies including better identification of APAP users, more accurately diagnosed ADHD cases, and more rigorous tackling of confounding by indication by (1) more thoroughly controlling for indications for prenatal APAP use, (2) employing propensity score statistical methodology to ensure comparability between APAP users and non-users, and (3) using an indication control group to conduct a sensitivity analysis. Offspring will be followed for physician-diagnosed ADHD from birth to the end of the study, up to 30 years. Such long-term follow-up will allow for more complete identification of ADHD cases, improving upon two additional limitations of previous studies that relied on maternal-reported ADHD and a short follow-up time (< 5 years). Our ability to identify APAP users more completely (about 50% of pregnant women identified as users), compared to only 7.5% in the Swedish study published in JAMA cited by many, suggests an important strength of the study design. The study will examine the overall association, sex-specific association as observed in our pilot study, and effects of gestational age of APAP use (timing) and duration of use (dose-response relationship). We will also explore gene-environment interaction and the association for ADHD with co-occurring autism spectrum disorder for which our pilot study showed an especially strong association. In addition to the unique data infrastructure and innovative design (scientific rigor), the study is supported by our strong pilot data, well-established underlying biology and emerging meta-analysis results, and could provide much needed data about this potential link from a U.S. population (better generalizability).


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2027 ( Subtotal = $0 )
2027	2026	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Child Health and Human Development Extramural Research	000	1	10/15/2026	NEW	$0
														Subtotal = $0

Issue Date FY: 2026 ( Subtotal = $706,235 )
2026	2026	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Child Health and Human Development Extramural Research	000	1	9/17/2026	NEW	$706,235
														Subtotal = $706,235

Grand Total All Awards = $706,235

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Maternal Use of Acetaminophen During Pregnancy and the Risk of Attention Deficit/Hyperactivity Disorder (ADHD) in Offspring: Developmental Origin of Neurodevelopmental Disorders

Award Number: R01HD122839

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/21/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2030

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