Safety of Empagliflozin in Patients with Type 2 Diabetes Mellitus in Saudi Arabia: A Post-Authorisation Safety Study

Abstract

Background: Empagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor is used as a monotherapy or in combination for lowering the elevated blood glucose level in patients with type 2 diabetes mellitus (T2DM). It is often associated with certain adverse reactions (urinary tract infection (UTI), diabetes ketoacidosis (DKA), and genital infections). Thus, the Saudi Food and Drug Administration requested a post-authorisation safety study to monitor the safety of empagliflozin during the defined observation period.