Diabetes Rounds

FDA Warning: Fournier Gangrene and SGLT2 Inhibitors


Use of sodium–glucose cotransporter-2 (SGLT2) inhibitors has been associated with Fournier gangrene (FG), a rare urologic emergency characterized by necrotizing infection of the external genitalia, perineum, and perianal region.


To describe and compare reported cases of FG in diabetic adults receiving treatment with SGLT2 inhibitors or other antiglycemic agents.


Descriptive case series.


U.S. Food and Drug Administration (FDA) Adverse Event Reporting System and published case reports.


Adults receiving SGLT2 inhibitors or other antiglycemic agents.


Clinical and laboratory data.


The FDA identified 55 unique cases of FG in patients receiving SGLT2 inhibitors between 1 March 2013 and 31 January 2019. The patients ranged in age from 33 to 87 years; 39 were men, and 16 were women. Time to onset after initiation of SGLT2-inhibitor therapy ranged from 5 days to 49 months. All patients had surgical debridement and were severely ill. Reported complications included diabetic ketoacidosis ( n = 8), sepsis or septic shock ( n = 9), and acute kidney injury ( n = 4). Eight patients had fecal diversion surgery, 2 patients developed necrotizing fasciitis of a lower extremity that required amputation, and 1 patient required a lower-extremity bypass procedure because of gangrenous toes. Three patients died. For comparison, the FDA identified 19 FG cases associated with other antiglycemic agents between 1984 and 31 January 2019: metformin ( n = 8), insulin glargine ( n = 6), short-acting insulin ( n = 2), sitagliptin plus metformin ( n = 2), and dulaglutide ( n = 1). These patients ranged in age from 42 to 79 years; 12 were men, and 7 were women. Two patients died.


Inability to establish causality or incidence, variable quality of reports, possible underreporting, and confounding by indication.


FG is a newly identified safety concern in patients receiving SGLT2 inhibitors. Physicians prescribing these agents should be aware of this possible complication and have a high index of suspicion to recognize it in its early stages.

More at https://annals.org/aim/article-abstract/2732837/fournier-gangrene-associated-sodium-glucose-cotransporter-2-inhibitors-review-spontaneous?doi=10.7326%2FM19-0085