Evaluation of suspected adverse drug reactions of oral anti-diabetic drugs in a tertiary care hospital of Bihar, India: An observational study

Abstract

Diabetic patients generally require life-long treatment and continuous follow up. In spite of their benefit of achieving glycemic control, there are many safety concerns with antidiabetic drugs such as gastrointestinal side effects, metabolic complications, central nervous system (CNS) symptoms, musculo-skeletal problems, genito-urinary disorders like UTI, development of peripheral oedema, weight gain etc. To highlight pattern of Adverse Drug Reactions with use of oral anti-diabetic drugs.All suspected Adverse Drug Reaction Reporting Form having any anti-diabetic drug as suspected cause of ADR were collected. The reported ADRs on the notification forms, after being confirmed by the physician-in-charge, were assessed for causality using WHO-UMC Causality Categories14, preventability using Modified-Schumock and Thornton scale15 and severity using Modified Hartwig and Siegel scale.: The data from the forms was presented in tabular form and data will be interpreted by using Microsoft Excel 365 software. Adverse drug reaction related to gastrointestinal system were most reported ADRs (41.31%). Among GI adverse events, nausea was mostly reported ADR and it was mostly associated with DPP-4 inhibitors. Hypoglycemia was most frequently observed in patients taking sulfonylureas. Causality assessment according to WHO-UMC criteria showed 61.68% ADRs had probable causality while 37.43% had possible causality and only 0.90% had certain causality. Most of the ADRs in our study were non-preventable (57.78%) & were of mild to moderate grade. Hypoglycemia continues to be major concern in patients taking anti-diabetic medications and sulfonylureas were commonest drugs responsible for it. As anti-diabetic medication is generally taken for lifetime, the risk of development of adverse effects related to concurrent related co-morbidities of patients shouldn’t be ignored while prescribing. The physician should report these adverse effects to ADR monitoring centre, so that proper signal could be generated for the welfare of the society.