Adverse Drug Events Associated With Selective Serotonin Reuptake Inhibitor Use During Pregnancy: A Pharmacovigilance Analysis Based on Real‐World Data

Purpose The study aims at providing valuable insights of safety of SSRI during pregnancy that assist the surveillance and possibly a timely intervention, by exploring the serious adverse drug events (ADEs) of SSRIs during pregnancy by conducting a pharmacovigilance analysis based on FDA adverse event reporting system (FAERS), and investigating comprehensive influencing factors of ADEs in real‐word settings. Methods The association between 5 commonly used SSRIs (i.e., paroxetine, fluoxetine, escitalopram, sertraline and citalopram) and ADEs was assessed by performing a disproportionality analysis. Cases were classified into serious and nonserious ADE groups based on their clinical outcomes, and their general characteristics were described. Influencing factors of occurrence of serious ADEs were identified through logistic regression. Conclusions We first investigated ADEs associated with SSRI use during pregnancy based on real‐world data. Our research highlights the clinical significance of proper SSRI option, depression severity and concomitant drug use in reducing serious ADEs.