Pharmacovigilance of selective serotonin reuptake inhibitors in depressive patients: A retrospective cross-sectional study

Objective: To assess the prevalence, frequency, and severity of adverse effects associated with selective serotonin reuptake inhibitors (SSRIs) in Turkish adult depressed patients. Method: Our cross-sectional study used a retrospective approach by reviewing medical records in the psychiatric settings of Atatürk Hospital and Manavgat State Hospital in Antalya, Turkey, from September 2023 to January 2024. This review focused on adult patients with major depressive disorder (MDD) undergoing SSRI monotherapy, including vortioxetine. Adverse effects' prevalence, frequency, and severity in 169 eligible patients were assessed using the Toronto Side Effect Scale, previously documented during prior admissions, and analysed using SPSS, with a significance level of P < .05. Results: Out of 169 examined depressed patients, 75.15 % were female, with an average age of 37.9 years ± 12.8. All received monotherapy, primarily with escitalopram, followed by fluoxetine, sertraline, paroxetine, and vortioxetine. Approximately 43.8 % (n = 74) of them reported adverse effects, with increased sleep (n = 14) being the most common, followed by decreased sleep, weight gain, and dizziness (n = 8 each). Escitalopram had the highest occurrence at 44.59 %, while sertraline was the only SSRI with significantly lower adverse effects than expected (p = 0.041). Frequency analysis showed that about 60% of the reported adverse effects occurred sometimes, 21% half the time, 11% often, and 8% daily. Regarding severity, mild trouble was the most common (43 %), followed by moderate (23 %), severe (12 %), extreme (8 %), and no trouble (13 %). Conclusion: Although adverse effects are relatively common in depressed patients, it should be emphasized that they do not affect the quality of life much, but cause serious problems in 8% of patients. However, larger studies are needed to evaluate the adverse effects of drugs used in depression. Keywords: SSRIs, major depressive disorder, adverse effects, pharmacovigilance,