All these drugs are giving promising results in the treatment of diabetes mellitus, but emerging data from post-marketing studies indicate their adverse effects such as diabetic ketoacidosis, genital and urinary tract infection, cancer, bone fracture and foot and leg amputation. Thus, there is a need for better understanding the risk profile of SGLT2 inhibitors. In this review, we have compiled the risk profile of SGLT2 inhibitors by collecting information from various sources such as case reports, published literature and from various regulatory websites. Further, the proposed mechanism of risks has also been discussed.
Background: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 SGLT2 inhibitors.
Materials and 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 the analysis of risk.
Results and Discussion:The emerging evidence indicates 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.
Conclusion: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.
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