"SAFETY PROFILE OF MIRTAZAPINE: A REAL-WORLD DISPROPORTIONALITY ANALYSIS OF FDA ADVERSE EVENT REPORTING SYSTEM (FAERS) "

Abstract

Introduction: Mirtazapine is an antidepressant drug that produces both noradrenergic and serotonergic activity. It is effective in treating of mild to severe depression. Proper evidence pointing to the safety of Mirtazapine is not established. The need for post-marketing surveillance (PMS) is considered most essential. This study was aimed to generate signal for unreported adverse drug reactions for Mirtazapine.

 Materials and Methods: Our study retrospectively analyzed the AEs reported entered in the Adverse Events Reporting System (FAERS) databases in the last 10-years during the period of Jan 2011 to June 2020. Disproportionality analysis was done using Reporting Odds Ratio, Proportional Reporting Ratio, and Information Component with 95% confidence interval.

Results: A disproportionality analysis was done for 41 adverse events, out of these, signal for 11 adverse events was found. ROR values 10.17 being the highest for abulia and 2.22 being the lowest for homicidal Ideation. The PRR value was 10.17 being the highest for abulia and 2.22 being the lowest for homicidal ideation. The IC025 value was 1.87 for abulia and 0.27 for homicidal Ideation.

Conclusion: The present study using the Adverse Events Reporting System (FAERS) databases maintained by the FDA suggested new safety signals for Mirtazapine. Still more cohort and epidemiological studies are recommended to validate these results.

Keywords: Mirtazapine, Disproportionality analysis, Safety Signals.