Global Strategies for Clinical Pharmacology and Labelling in the Treatment of Mental Disorders in Pregnant and Lactating People

Session Description

Treating mental disorders in pregnant and lactating people involves balancing the benefits and risks of antidepressants and antipsychotics. This session addresses the critical considerations for this population, employing advanced methodologies and regulatory insights to promote safer clinical practices and informed labelling.

The session will provide an evidence-based overview of the diagnosis and treatment of mood and anxiety disorders during pregnancy and postpartum. It will cover the risks of untreated psychiatric illness and the use of psychotropic medications, emphasizing impacts on both mother and child. Practical guidance will be offered for assessing symptoms, conducting risk assessments, and developing suitable treatment plans.

The session will also explore the use of PBPK models to assess the risks and benefits of antidepressant treatments during pregnancy and lactation. By evaluating drug exposure and potential toxicity in maternal and infant populations, these models could aid in informed clinical decisions regarding the safety and appropriateness of treatments.

Additionally, the session will highlight the importance of clinical lactation studies to understand drug transfer into breastmilk and its potential consequences for breastfed infants. Current strategies for obtaining clinical lactation data, including the design and interpretation of these studies, will be discussed. Updates on efforts to increase data collection and collaborative, innovative approaches to gathering lactation data will also be provided.

By bringing together clinicians, researchers, and regulators, this session aims to foster a comprehensive dialogue on how to make informed clinical decisions that prioritize both the maternal mental health and infant safety. Participants will gain a deeper understanding of applying these advancements in their practices and the potential impacts on global health policy.

Learning Objectives

1. Gain insights on drug labelling and pharmacology for pregnant and lactating people from regulatory and clinical perspectives
2. Explore PBPK models for assessing antidepressant exposure in mothers and infants, aiding in safe clinical decision-making
3. Understand how emerging data shapes global treatment strategies and regulatory frameworks for this demographic

Session Schedule

Introduction
Kristin Bigos, PhD and Farzaneh Salem, PharmD, PhD

Insights on Clinical Pharmacology for Pregnant and Lactating People from Clinician Perspectives
Lindsay Standeven, MD

From Exposure to Safety: PBPK Model Insights on Antidepressant Use in Pregnancy and Lactation
Xian Pan, PhD

Clinical Lactation Studies of Neuropsychiatric Medications: Regulatory Perspectives
Venkateswaran Chithambaram Pillai, PhD

Panel Discussion