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

Authors: Kar S. K., Khuntia S., Nayak S.


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. 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 patient receiving metformin. Data were collected and analyzed to find out the demographic characteristics, causality and severity of adverse events with metformin regimens. The most common adverse drug reactions were lactic acidosis followed by hypoglycemia, hypersensitivity reactions, nausea, decreased appetite, vomiting, weakness and diarrhea. It was seen that 8 % 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 Hartwig and Siegel’s severity Scale (n=143) indicates 64% of case were mild and 34% of cases are moderately severe. This study provided the information regarding the adverse drug reactions that could be developed in any patient and increases the risk to the patient. Hence with an aim of patient safety quality of the drug formulations has be improved that could ultimately improves the drug safety.

Keywords: Metformin, diabetes, anti-diabetic therapy, adverse events,

Article ID: 20201205