Evaluation of adverse drug reactions in patients with Type II diabetes mellitus in tertiary care hospitals, Bhopal

Background: Pharmacovigilance is the science which deals with adverse drug reactions (ADRs) appear after long and short drug treatment. ADRs monitoring is essential to gain knowledge of drugs reaction for betterment of mankind. In the present study, observation of ADRs in Type II diabetic patients was conducted in tertiary care hospitals, Bhopal. ADRs reported in the present study were diarrhea, myalgia, flatulence, palpitations, rash, itching, etc., in patients receiving oral hypoglycemic agents. So through this observation, we want to acknowledge the various adverse effects occurred by oral hypoglycemic agents for reduction of morbidity and mortality in Type II Diabetic patients. Aims and Objectives: (1) The objectives of the study were to ADRs monitoring in Type II Diabetic patients receiving oral anti-diabetic agents and (2) to compare ADRs in conventional versus newer anti-diabetic agents therapies in Type II Diabetic patients. Materials and Methods: 150 patients were enrolled for evaluating adverse effects with oral antidiabetic agents. All patients were followed up by medical history, history of drugs, and any severity of ADR. Causality was graded by Naranjo scale. Results: 45 patients (30%) with mean age of 64.6 year (SD = 2.41) complained adverse effects and out of which 17 (11.3%) patients were reported to the physician. The most common adverse effect was found with sulfonylureas, biguanides, and thiazolidinediones such as hypoglycemia, weight gain, gastrointestinal (GI) disturbances allergic reactions, and dizziness probability of adverse effects more common in females (64.17%) in comparison to male (35.29%) patients. Conclusion: In Type II Diabetic patients receiving oral antidiabetic agents provides a fruitful information about a ADRs and enhance knowledge about pharmacovigilance to health-care providers. However, predominance of adverse effects in female diabetic patients was reported. Hypoglycemia, weight gain, and GI tract disturbances were observed frequently with oral antidiabetic agent in middle age diabetic patients. By this information, we can prevent drug related complications and improve quality of life of a person