(P-435) Comparison of Safety Signals Between Selective Serotonin-reuptake Inhibitors (SSRI) and Serotonin–norepinephrine Reuptake Inhibitors (SNRI) Employing Fda Adverse Event Reporting System (FAERS) Database

Background: Depression is a common medical illness that negatively affects feelings which leads to emotional and physical problems including decreased motor function. Selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) are used to treat depression.

Objectives: Antidepressants are reported to cause unpleasant adverse reactions. This study aimed to compare the safety signal of SSRI and SNRI using the adverse events reported in the FAERS database employing disproportionality analysis.

Methods: Publicly available FAERS data of SSRI (sertraline, fluoxetine, fluvoxamine, citalopram, escitalopram, paroxetine, dapoxetine, vortioxetine) and SNRI (duloxetine, venlafaxine, desvenlafaxine, atomoxetine, milnacipran, levomilnacipran) up to 2020 Q4 was used. Disproportionality analyses with Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) with 95% confidence intervals (95% CI) were calculated. A value of ROR-1.96SE>1, PRR≥2, count of co-occurrences is 3 or more, with an associated χ2 value of 4 or more were considered as a positive signal.

Results: FAERS database had a total of 2, 83,166 cases of SSRI and 1, 65,774 cases of SNRI. The detected adverse events were; Psychiatric disorders- paranoia in SSRIs with PRR 5.617 (4.50; 7.00) and ROR 5.61 (4.50; 7.00) vs. SNRIs with PRR 4.50 (3.34; 6.05) and ROR 4.50 (3.35; 6.05), bipolar disorder with PRR 5.03 (4.71; 5.37) and ROR 5.04 (4.73; 5.38) vs. SNRIs with PRR 5.46 (5.06; 5.90) and ROR 5.48 (5.07; 5.92). Neurological disorders - serotonin syndrome in SSRIs with PRR 15.10 (14.57; 15.65) and ROR 31.88 (30.55; 33.26) vs. SNRIs with PRR 18.28 (17.44; 19.16) and ROR 18.49 (17.64; 19.39). Renal disorders- acute kidney injury in SSRIs with PRR 1.22 (1.17; 1.28) and ROR 1.22 (1.18; 1.27) vs. SNRIs with PRR 0.94 (0.89; 1.00) and ROR 0.94 (0.89; 1.00). Cardiac disorders- Torsade de pointes in SSRIs with PRR 6.08 (5.62; 6.57) and ROR 6.09 (5.63; 6.59) vs. SNRIs with PRR 1.02 (0.82; 1.26) and ROR 1.02 (0.82; 1.26).

Conclusions: The number of adverse events reported for SSRI is observed to be more compared with SNRI based on disproportionality analysis. Although a causal relation cannot be definitively proved, the number of cases reported suggests that there might be an association. Therefore, the patient should be monitored for the reported events during the administration of SSRI and SNRI.