A scientific approach to hemorrhage risk assessment of SSRIs/SNRIs utilizing the FAERS database

Abstract

Objectives

Hemorrhage represents a notable adverse event (AE) associated with the utilization of SSRIs and SNRIs. This study aimed to provide valuable insights for clinical practice by providing a comprehensive understanding of hemorrhage events associated with SSRIs/SNRIs.

Methods

Ten-year data on the main SSRIs/SNRIs were extracted from the FAERS database for the period spanning from 2014 to 2023. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) were employed to quantify the signals. Finally, a comparative analysis was conducted between demographic data, outcomes, and inherent associations among the medications and the signals.

Results

Approximately 3.86% of all patients who experienced adverse effects with SSRIs/SNRIs were found to have hemorrhage-related AEs (HrAEs). The majority of these patients were female and aged sixty years or older. The primary outcomes for patients experiencing HrAEs included initial or prolonged hospitalization, mortality, life-threatening conditions, and other complications. After conducting an analysis using ROR and PRR methods, we obtained several positive signals for HrAE (p-HrAEs). Gastrointestinal and nervous system disorders were identified as the predominant p-HrAEs. Sertraline demonstrated the most pronounced signals for gastrointestinal disorders, particularly upper gastrointestinal hemorrhage. Correlations have been observed between the use of citalopram, escitalopram, paroxetine, venlafaxine and cerebral/cerebellar hematoma in terms of nervous system. However, duloxetine did not result in any signals in these two systems.

Conclusions

p-HrAEs associated with SSRIs/SNRIs were identified through real-world pharmacovigilance analysis. It is anticipated that this paper will offer additional information regarding safe and rational medication for patients taking antidepressants.