OBJECTIVES: Empagliflozin is a Sodium-Glucose cotransporter 2 (SGLT2) inhibitor approved by the US Food and Drug Administration (FDA) in 2014 for the treatment of type-2 Diabetes Mellitus. This study aims in the identification of Pancreatitis associated with Empagliflozin using disproportionality analysis of the FDA database of Adverse Event Reporting System (FAERS).

METHODS: Data were obtained from the public release of data in FAERS. Case/non-case method was adopted for the analysis of association between empagliflozin use and pancreatitis. The data mining algorithm used for the analysis were Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). A value of ROR-1.96SE>1, PRR≥2 were considered as positive signal.

RESULTS: A total of 31,070 reports for Pancreatitis have been reported in the FDA database. Among them 148 reports were associated with Empagliflozin. Pancreatitis was ranked 27^th among 900 Empagliflozin associated Adverse Events (AEs). The mean age was 32.29 (95% CI; 27.49- 37.10) and female to male ratio was 1.04:1. A positive signal was obtained with ROR: 4.10 and PRR: 4.09. Serious reports included hospitalization (76), life-threatening (12), disability (1) and other serious events (107) and one death was reported. Linear regression analysis indicated there was no significant correlation between the PRR and time (R=0.491; p=0.400) and ROR and time (R=0.480; p=0.413). The Log Likelihood ratio for Pancreatitis with Empagliflozin was found to be 4.81 and the reporting ratio was 4.29 (Critical value- 5.25).

CONCLUSIONS: A positive signal was observed for empagliflozin associated pancreatitis, although a causal relation cannot be definitively established. Further monitoring of this AE associated with empagliflozin is necessary in future as the number of cases of pancreatitis are increasing. Health care professionals should be cautious about the possibility of encountering serious AEs associated with empagliflozin.