Recently, Food and Drug Administration (FDA) has approved sodium/glucose co-transporter 2 (SGLT2) inhibitors for the treatment of diabetes mellitus. However, regarding adverse drug reactions (ADRs) of SGLT2 inhibitors in large group of population, very less information is available. Thus, we have tried to find out the risk profile of SGLT 2 inhibitors.
Material & Methods:
A total of 1,042 studies have been published from Nov. 2012-Nov.2017 regarding SGLT2 inhibitors. After inclusion and exclusion criteria, 27 studies have been selected for analysis of risk.
Results and Discussion:
The emerging evidence indicate various adverse drug reactions such as foot and toe amputation, cancer, diabetic ketoacidosis, bone fracture risk and urinary as well as mycotic genital infection. The causality assessment has shown a correlation between SGLT2 inhibitors and diabetic ketoacidosis and urinary tract infection.
In conclusion, Marketing Authorization Holder (MAH) and Regulatory Authorities (RA) should monitor various adverse drug reactions such as diabetic ketoacidosis and urinary tract infection with the use of SGLT2 inhibitor.