Cardiovascular toxicity induced by SSRIs: Analysis of spontaneous reports submitted to FAERS

Psychiatry Res. 2023 Aug:326:115300. doi: 10.1016/j.psychres.2023.115300. Epub 2023 Jun 22.

Abstract

Depression diagnoses have surged recently, and selective serotonin reuptake inhibitors (SSRIs) are the go-to treatment. However, studies indicate that long-term use of SSRIs can increase cardiovascular risk without systematic evaluation of the drug class. To offer clinical guidance, we performed an evaluation of the association between the six most commonly prescribed SSRIs and cardiovascular adverse events. Using the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q2 2022, we conducted a disproportionality analysis and determined the magnitude of significant signals using statistical shrinkage transformations. Our study revealed that arrhythmias, torsades de pointes/QT prolongation, cardiomyopathy, and hypertension were among the most prevalent adverse events linked to SSRIs. Our analysis also showed a significant association between SSRIs and the aforementioned adverse events, with higher incidence in middle-aged and elderly patients and women. We further observed a rising trend in the incidence of arrhythmias, torsades de pointes/QT prolongation, and hypertension, highlighting the need for heightened cardiac monitoring in patients on SSRIs.

Keywords: Cardiovascular adverse event; Data mining; Disproportionality analysis; Faers database; SSRIs.

MeSH terms

  • Adverse Drug Reaction Reporting Systems
  • Aged
  • Female
  • Humans
  • Hypertension* / chemically induced
  • Hypertension* / epidemiology
  • Long QT Syndrome* / chemically induced
  • Long QT Syndrome* / epidemiology
  • Middle Aged
  • Selective Serotonin Reuptake Inhibitors / adverse effects
  • Torsades de Pointes* / chemically induced
  • Torsades de Pointes* / epidemiology

Substances

  • Selective Serotonin Reuptake Inhibitors