Publication:

Adverse drug reactions monitoring of newer oral hypoglycemic drugs in a tertiary care hospital of North India: a prospective study

Background Diabetes Mellitus (DM) is a metabolic disorder characterized by hyperglycemia. In majority of patients oral hypoglycemic drugs remain the primary agents in management of DM. Currently there are variety of new drugs are approved in management of DM of which safety is established in clinical trials but there surveillance is needed for reporting newer adverse effects which are not documented yet.

Methods 112 patients were screened with the help of a predefined inclusion and exclusion criteria for the study and followed up for three months. The drugs which are relatively new and have been in the market for around 5-7 years were taken as new drug. These include specifically the following drugs: DPP-IV Inhibitors, PPAR α/γ agonist, SGLT-2 inhibitors. They were screened and investigated suitably for any ADRs. The severity of the adverse drug reactions was graded according to the Hartwig’s Severity Assessment Scale and Naranjo Scale was used for causality assessment between the drug and suspected reaction.

Results Maximum ADRs reported belonged to gastro intestinal system (53%). DPP-IV inhibitors showed maximum number of ADRs i.e. 70.6%. Majority of ADRs reported were mild i.e. 52.9%. Overall 15.2% patients reported ADRs. Majority of ADRs reported (70.6%) belonged to category ‘possible’.

Conclusions All three class of newer oral hypoglycemics seems reasonably safe to be used in general practice. As the number of patients were small, we need larger study to substantiate the findings.