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New Safety Concern Identified for Patients Receiving SGLT2 Inhibitors

June 06, 2019

The US Food and Drug Administration (FDA) is warning health care providers of a new safety concern in patients with diabetes prescribed sodium-glucose cotransporter-2 (SGLT2) inhibitors: Fournier gangrene.

“Use of SGLT2 inhibitors has been associated with Fournier gangrene, a rare urologic emergency characterized by necrotizing infection of the external genitalia, perineum, and perianal region,” researchers reported in a descriptive case series published online in the Annals of Internal Medicine.

Between March 1, 2013, and January 31, 2019, 55 cases of Fournier gangrene in 39 men and 16 women receiving SGLT2 inhibitors were reported to the FDA, according to the report. Time to Fournier-gangrene onset ranged from 5 days to 49 months after initiation of SGLT2-inhibitor therapy.

All patients, who ranged in age from 33 to 87 years, were severely ill and received surgical debridement. Complications included diabetic ketoacidosis in eight patients, sepsis or septic shock in nine patients, and acute kidney injury in four patients.

“Eight patients had fecal diversion surgery, two patients developed necrotizing fasciitis of a lower extremity that required amputation, and one patient required a lower-extremity bypass procedure because of gangrenous toes,” the researchers wrote. “Three patients died.”

For comparison, researchers shared similar details of 19 reported cases of Fournier gangrene associated with antiglycemic medications other than SGLT2 inhibitors between 1984 and January 31, 2019. Eight involved metformin, six involved glargine, two involved short-acting insulin, two involved sitagliptin plus metformin, and one involved dulaglutide. The 12 men and 7 women affected ranged in age from 42 to 79 years, according to the paper. Two patients died.

“Fournier gangrene is a newly identified safety concern in patients receiving SGLT2 inhibitor,” researchers concluded. “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.”

Jolynn Tumolo


Bersoff-Matcha SJ, Chamberlain C, Cao C, Kortepeter C, Chong WH. Fournier gangrene associated with sodium-glucose cotransporter-2 inhibitors: a review of spontaneous postmarketing cases. Annals of Internal Medicine. 2019 May 7;[Epub ahead of print].

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