Prevalence of Adverse Drug Reactions in Diabetic patients receiving Antidiabetic Medications at Tertiary Care Hospital

Abstract

Background: Diabetes mellitus is a chronic metabolic condition defined by elevated blood glucose levels caused by abnormalities in insulin secretion, insulin action, or both. Anti-diabetic drug pharmacovigilance can be extremely useful in identifying and resolving the adverse drug reactions (ADRs) and safeguarding patients from needless injury. Objective: The objective of the study was to determine the prevalence of various adverse events caused by the use of anti-diabetic medications in patients treated at tertiary care hospital. Method: It was a randomized controlled study where the participants were randomized into two groups i.e., interventional or study group and control group. All suspected ADRs were collected, analysed and confirmed by the physician-in-charge and were assessed for causality using WHO-UMC Causality Categories, Naranjo’s causality assessment scale, preventability using Modified-Schumock and Thornton scale, severity using Modified Hartwig and Siegel scale by the Causality Assessment Committee (CAC). Results: The study included a total of 300 subjects among which 218 were male (72.67%) and 82 were female (27.33%). A total of 300 patients, 104 ADRs were identified, in which 46.15% were observed in the control group and 53.85% in the interventional group. Females were more prevalent to the ADRs. The majority of ADRs were seen in age group of >70 in which 15.38% were observed in the control group and 18.27% in the interventional group. The Highest observed ADR of 20 (19.23%) was Hypoglycemia in which 9(8.65) were observed in the control group and 11(10.57) in the interventional group followed by weight gain i.e, 10 (9.61%) in which 5(4.80%) were observed in the control group and 5(4.80%) in the interventional group. Conclusion: ADR relating to antidiabetic therapy utilizing oral antidiabetics and insulin was found to be prevalent. The doctors and clinical pharmacists are therefore needed to identify and report the appropriate signals generated to the nearest ADR monitoring centre or Pharmacovigilance Programme of India for the benefit of the patients.