Characterization of suspected adverse events related to lithium use in the treatment of bipolar disorder and analysis of associated genetic variants: a cross-sectional study and integrative review

• Grant number: 25/08035-5
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: August 01, 2025
• End date: July 31, 2026
• Field of knowledge: Health Sciences - Pharmacy
• Principal Investigator: Marcela Forgerini
• Grantee: Ana Luiza da Silva Selani
• Host Institution: Faculdade de Ciências Farmacêuticas (FCFAR). Universidade Estadual Paulista (UNESP). Campus de Araraquara. Araraquara , SP, Brazil

Abstract

Introduction: Lithium carbonate is the gold-standard mood stabilizer for the treatment of bipolar disorder (BD). However, its use may be associated with adverse events that can compromise treatment adherence and patient safety. In this context, Anvisa's spontaneous adverse event reporting system (VigiMed) is a relevant pharmacovigilance tool for identifying potential safety signals. Moreover, there is evidence that genetic factors influence both therapeutic response and susceptibility to adverse events, reinforcing the importance of integrating pharmacovigilance and pharmacogenetics data. Objective: To describe spontaneous reports of suspected adverse events related to lithium use in patients with BD, recorded in the VigiMed database, and to investigate genetic variants associated with susceptibility to the most frequently reported events. Methodology: A cross-sectional study will be conducted using reports registered in VigiMed between December 2018 and December 2024. Reports that meet the minimum quality criteria defined by the Pan American Health Organization will be included. Data on sex, age, reporter, reported event, severity, and outcome will be extracted. Subsequently, an integrative review will be conducted in Scopus and PubMed to identify evidence on the influence of genetic variants in the predisposition to the most frequently reported events. Study screening and eligibility will be carried out independently by two reviewers. Expected results: To characterize lithium-related reports and identify genetic variants associated with the occurrence of the most frequent adverse events, contributing to medication safety.