# Active Surveillance of the Safety of Antipsychotic Medications in Pregnancy

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2024 · $526,905

## Abstract

Mental health conditions are common among pregnant and postpartum women as well as non-pregnant
women of reproductive age. While many patients require pharmacologic treatment, the safety of psychotropic
medications in pregnancy is an area with large evidence gaps. Historically, spontaneous reports, pregnancy
exposure registries, and case-control designs were the main approaches used to evaluate the safety of
psychotropic medications in pregnancy, all of which have well-known limitations. In recent years, the field has
gained much expertise with the conduct of cohort studies nested in large healthcare utilization data. Across all
these designs, studies tend to focus on a single or a few selected adverse pregnancy outcomes, and they are
performed at a single time point many years after the drug has entered the market and has been used by many
pregnant women. To avoid unnecessary exposure of mother and fetus to harmful medications or to avoid
women being unnecessarily deprived of treatments for psychiatric disorders when no harmful effects exist, a
new and systematic approach is needed to generate timely evidence on the safety of psychotropic medications
in pregnancy with respect to all relevant maternal and fetal outcomes.
We will develop and implement a TreeScan based approach to conduct active surveillance of antipsychotic
medication safety in pregnancy. TreeScan is a novel method for drug safety surveillance, which scans
hierarchical trees of specific outcomes as well as groups of clinically related outcomes for associations with the
treatment of interest, while accounting for multiple testing of correlated hypotheses. We will first develop
hierarchical trees for congenital malformations, maternal and other neonatal outcomes based on shared
underlying disease processes, and modify the TreeScan approach to accommodate the unique challenges of
drug safety evaluation in the context of pregnancy. Use of hierarchical trees increases power to detect clinically
related outcomes, which would not be feasible by evaluating individual diagnoses only. We will then implement
TreeScan to evaluate the risks of a broad range of adverse maternal and neonatal outcomes associated with
antipsychotic medications. Antipsychotics are the mainstay of treatment for women with schizophrenia and
bipolar disorder, but little is known regarding their safety profile in pregnancy, especially for the newer
antipsychotics. We will use nationwide cohorts of over 3.5 million publicly and privately insured pregnancies in
the US, nested in healthcare utilization databases that contain rich information on confounders. In the final aim,
we will extend the approach to conduct near real-time prospective, sequential surveillance of newly approved
antipsychotic and other psychotropic medications in order to detect potential safety signals as early as possible
after approval. By providing the necessary information for healthcare providers to make evidence-based
prescribing decisions and t...

## Key facts

- **NIH application ID:** 10794403
- **Project number:** 5R01HD104646-04
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Krista F Huybrechts
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $526,905
- **Award type:** 5
- **Project period:** 2021-04-12 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10794403

## Citation

> US National Institutes of Health, RePORTER application 10794403, Active Surveillance of the Safety of Antipsychotic Medications in Pregnancy (5R01HD104646-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10794403. Licensed CC0.

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