Adverse drug reaction monitoring of newer oral anti-diabetic drugs - A pharmacovigilance perspective

Objective: To monitor and evaluate adverse drug reactions (ADRs) of newer oral anti-diabetic drugs in type II diabetics by spontaneous/solicited ADR monitoring. Material and methods: Two hundred and thirty two diabetic patients on newer oral antidiabetic drugs were evaluated prospectively in a cross-sectional study over a period of eighteen months. All patients were followed up for ADRs which were evaluated for incidence, frequency, severity and causality. ADR severity was graded according to University of Virginia Health System Adverse Drug Reaction Reporting program criteria and causality assessment was done using WHO-UMC scale. Results: 190 out of 232 patients (42 patients lost to follow up) were evaluated. ADRs were observed in 34 cases (17.9%). Most common ADRs were gastrointestinal (44.2%) followed by musculoskeletal (17.6%), metabolic (14.7%), infections (5.9%) and others (17.6%). The maximal frequency of ADRs was seen with sitagliptin (6.4%) followed by vildagliptin(3.8%), saxagliptin(2.7%), saroglitazar(2.1%), linagliptin(1.6%), canagliflozin(1.6%). 25(73.5%), 8(23.5%) and 1(3%) ADRs were mild, moderate and severe respectively. 24(70%) ADRs were classified as possible, 9(27%) probable and 1(3%) unlikely on causality assessment.  Conclusion : Newer oral antidiabetic drugs like gliptins and SGLT-2 inhibitors have potential to cause ADRs. Gastro-intestinal, musculoskeletal, metabolic were most common ADRs. Active pharmacovigilance should be carried out for risk identification and management.