Safety concerns of maternal antiseizure medications exposure on perinatal and offspring outcomes – A disproportionality analysis based on FDA adverse event reporting system (2025) Yanbin Zeng

Description

This study analyzed data from the FDA Adverse Event Reporting System (2010–2023) using disproportionality analysis (ROR and BCPNN) to assess pregnancy and offspring toxicity resulting from maternal exposure to antiseizure medications (ASMs). The analysis identified signals for malformation, adverse perinatal outcomes, and dysplasia associated with both traditional (VPA, CBZ) and newer ASMs (LEV, LTG, TPM), highlighting specific risks and urging heightened attention to combination therapies due to potential risks associated with LEV and LTG.