A pharmacovigilance study of oral antidiabetic drugs in patients with type 2 diabetes mellitus
Keywords:
anti-diabetic drug, adverse drug reaction, who scale, causalty assessmentAbstract
The aim of the study to to evaluate and analyse ADRs in type II diabetic patients and to determine the causality and safety profile of all the prescribed medicationsMethods: A prospective study was carried out in diabetic patients visiting the Diabetic OPD and those fulfilling inclusion criteria were included in study. ADR observed were obtained from their Diabetic Diary and were recorded in the Case Record Form to evaluate the incidence,frequency, severity and causalityResults: A total of 81 ADRs were reported from206 patients. The class of drug responsible for causing more ADRs was found to be biguanides. The mostcommonly affected organ system was GI System. The suspected ADRs were assessed for their causality,it wasrevealed that 26 were probable and 55 were possible as per WHO Scale. Conclusions: The present study helps to understand importance of ADR reporting to ensure maximum benefits of drugtherapy. As the cases of new onset diabetes is also increasing in Indian scenario as well as newer drugs are also developed to target the disease pathology, therefore active pharmacovigilance should be carried out for risk identification and management.
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