Metformin related adverse events: A prospective observational study in health care centers of western Odisha

Introduction: The most common adverse drug reactions were lactic acidosis followed by hypoglycemia, hypersensitivity reactions, nausea, decreased appetite, vomiting, weakness, and diarrhea. Objectives: The study was done to explore the management of the patients having diabetes by primary care physicians, and the adverse reactions associated with the dose regimens. This study provided information regarding the adverse drug reactions that could be developed in any patient and increases the risk to the patient. Methods: A qualitative In-Depth Interview study was conducted among the primary care physicians at ten primary health care centers at Sambalpur city of Odisha, India. The data were analyzed using content analysis. This was a prospective observational study (March 2019 - September 2019) among diabetes patients receiving metformin. Data were collected and analyzed to find out the demographic characteristics, causality, and severity of adverse events with metformin regimens. Results: It was seen that 8 % of cases could be assessed as certain and 24 % could be assessed as probable. Most (60 %) cases were assessed as possible. Severity assessment of ADRs by modified Hart wig and Siegel's severity Scale (n=143) indicates 64% of the case were mild and 34% of cases are moderately severe. Conclusions: Hence with an aim of patient safety quality of the drug formulations has to be improved that could ultimately improve drug safety.