Cases of a rare but serious infection called Fournier's gangrene have been reported with sodium-glucose co-transporter-2 inhibitors (SGLT-2i). To evaluate the safety signal in a population of patients with type 2 diabetes, we used administrative claims data from Horizon Blue Cross Blue Shield of New Jersey from 2014 through 2017 to estimate incidence rates of Fournier's gangrene or necrotizing fasciitis of the perineum among patients treated with a second-line antidiabetic drug. We found very low incidence rates of Fournier's gangrene or necrotizing fasciitis. While we found no indication of an increased risk among SGLT-2i users compared with similar patients treated with other second-line antidiabetic medications, the small number of events yielded wide confidence intervals.
Keywords: cohort study; database research; observational study; pharmaco-epidemiology; sodium-glucose co-transporter-2 inhibitor; type 2 diabetes.
© 2019 John Wiley & Sons Ltd.