• May 2015 – Many reports of ketoacidosis and diabetic ketoacidosis (DKA) requiring hospitalization
• September 2015 – Label update warning about increased risk of bone fracture
• December 2015 – Label change for SGLT2 inhibitors about increased risk of ketoacidosis and serious urinary tract infections
• May 2016 – First amputation warning based on interim analysis of CANVAS and CANVAS-R studies
• June 2016 – Communication to doctors with stronger warnings about kidney injury risks
• May 2017 – Second amputation warning, requiring a label update with a boxed warning
• August 2018 – Invokana and other SGLT2 inhibitors may lead to a flesh-eating genital infection (Fournier’s gangrene or necrotizing fasciitis)