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The pharmacokinetic-pharmacodynamic (PK-PD) relationship describes the intricate link between drug exposure, efficacy, and toxicity, forming the foundation for optimal dosing regimens. This relationship uses mathematical modeling to characterize drug concentration-effect dynamics, ensuring precise therapeutic outcomes.Exposure represents the pharmacokinetic aspect of the PK-PD relationship, denoting the drug amount that elicits a biological response. It is typically quantified by administered...
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Psychotropic Medication Exposure via Breast Milk: A Population-Based Descriptive Study in Denmark.

Xiaoqin Liu1, Kathrine Bang Madsen1,2, Jin Liang Zhu1

  • 1NCRR-The National Centre for Register-Based Research, Department of Public Health, Aarhus University, Aarhus, Denmark.

Paediatric and Perinatal Epidemiology
|September 11, 2025
PubMed
Summary

Approximately 2% of exclusively breastfed infants in Denmark are exposed to psychotropic medications via breast milk. This exposure, particularly to antidepressants, has shown a significant upward trend from 2012 to 2022.

Keywords:
breastfeedingcohortepidemiologypsychotropic medicationregister

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Area of Science:

  • Perinatal pharmacology
  • Infant health
  • Psychiatric medication safety

Background:

  • Limited data exists on psychotropic medication transfer via breast milk to infants.
  • Understanding infant exposure is crucial for clinical practice and research.
  • This study addresses the need for data on psychotropic medication exposure in breastfed infants.

Purpose of the Study:

  • To determine the prevalence and trends of psychotropic medication exposure in exclusively breastfed infants.
  • To analyze exposure patterns by drug class and maternal factors.
  • To provide essential data for healthcare providers and researchers.

Main Methods:

  • Population-based descriptive study using Danish nationwide registers (2012-2022).
  • Identified maternal psychotropic prescriptions (ATC codes N05-N06) during breastfeeding.
  • Calculated prevalence per 1000 infants, stratified by drug class and maternal characteristics.

Main Results:

  • Over 446,000 infants studied; 17.6/1000 exposed to at least one psychotropic medication.
  • Antidepressants (15.0/1000), primarily sertraline, were the most common exposure.
  • Exposure increased by 39% from 2012 (15.7/1000) to 2022 (21.8/1000), with psychostimulants showing a notable rise.

Conclusions:

  • Around 2% of exclusively breastfed infants in Denmark experience potential psychotropic medication exposure.
  • A clear upward trend in psychotropic medication exposure was observed over the study period.
  • Prevalence varied based on maternal demographic and clinical factors, highlighting the need for individualized risk assessment.