# Prenatal medication exposure in autism, birth complications and developmental disabilities

> **NIH NIH R01** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2024 · $682,197

## Abstract

PROJECT SUMMARY
Autism spectrum disorder (ASD) affects 1 in 54 children in the US, however the modifiable risk factors for this
disorder remain unknown, creating a pressing public health need. As ASD likely arises early in prenatal
development, efforts in identifying such modifiable factors have focused on maternal exposures in pregnancy,
including medications. While some medications have been shown to be associated with ASD, major critical
knowledge gaps remain, including: (1) the underlying mechanisms have not been elucidated, and (2) the effects
of most maternal medications on ASD risk are still unknown — despite pervasive use of prescription and over-
the-counter (OTC) medications in pregnancy, most of which cross the placenta, with unknown effects on the
fetus. In response, the key objectives of the proposed study are to identify medications taken by pregnant women
that influence offspring ASD risk, elucidate confounding factors in these associations, and benchmark their
generalizability and specificity. To achieve these objectives, we propose independent, but synergistic aims: Aim
1: Systematically investigate the effects of the full range of maternal prescription and OTC medications used in
pregnancy on ASD offspring risk, using well-powered sample of 1.2M live births from Israel with full demographic,
prescription, medical and pedigree information. We will test if the observed effects on ASD differ depending on
the timing or duration of the exposure, concurrent use of other medications, indication or offspring sex. Aim 2:
Test the mechanisms underlying the associations between maternal medication use and ASD, 2A: examining
familial confounding, using sibling comparisons and negative control of paternal exposure; and 2B: identifying
clinical confounding by (i) examining risk of ASD associated with clusters of medications defined by their
pharmacological features (target(s), chemical structure) vs indication, (ii) adjustment for maternal health proxies;
(iii) discontinuation analysis. Aim 3: Establish the specificity and generalizability of maternal medication effects
on ASD, by 3A: examining the range of other (neuro)developmental outcomes affected by the same maternal
medications as ASD, and 3B: performing a replication study in Sweden, Finland and the US. The innovation of
this project is four-fold: (1) it can identify novel, potentially modifiable risk factors for ASD; (2) it triangulates
orthogonal approaches to discern causal vs confounded effects of medications on ASD risk; (3) it leverages
pharmacological and pharmacokinetic data on medications to unambiguously define exposure; and (4) it
provides new insights into shared and distinct risk factors in different adverse developmental outcomes. Upon
completion, our multi-dimensional approach, rigorous methods and unprecedented study power in the hands of
our expert team will deliver a systematic list of the maternal prescription and OTC medications in pregnancy
associated with ASD, and...

## Key facts

- **NIH application ID:** 10909176
- **Project number:** 5R01HD107528-03
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** MAGDALENA JANECKA
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $682,197
- **Award type:** 5
- **Project period:** 2022-09-13 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10909176

## Citation

> US National Institutes of Health, RePORTER application 10909176, Prenatal medication exposure in autism, birth complications and developmental disabilities (5R01HD107528-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10909176. Licensed CC0.

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