Fournier Gangrene Is Safety Concern With SGLT2 Inhibitors

FDA identified 55 cases of FG in patients on SGLT2 inhibitors from March 2013 through January 2019

MONDAY, May 13, 2019 (HealthDay News) -- Fournier gangrene (FG) is a safety concern for adults with diabetes receiving treatment with sodium-glucose cotransporter-2 (SGLT2) inhibitors, according to a study published online May 7 in the Annals of Internal Medicine.

Susan J. Bersoff-Matcha, M.D., from the U.S. Food and Drug Administration in Silver Spring, Maryland, and colleagues compare and describe cases of FG in adults with diabetes receiving SGLT2 inhibitors or other antiglycemic agents.

The researchers found 55 unique cases of FG in patients receiving SGLT2 inhibitors between March 1, 2013, and Jan. 31, 2019. The patients were aged 33 to 87 years; 39 and 16 were men and women, respectively. After initiation of SGLT2 inhibitor therapy, the time to onset varied from five days to 49 months. All patients had surgical debridement and were extremely ill. Reported complications included diabetic ketoacidosis (eight cases), sepsis or septic shock (nine cases), and acute kidney injury (four cases). Three patients died. In comparison, between 1984 and Jan. 31, 2019, the FDA identified 19 FG cases associated with other antiglycemic agents; two of these patients died.

"Awareness of the association between FG and SGLT2 inhibitor use may be an important factor in an informed prescriber-patient discussion regarding appropriate diabetes therapy," the authors write. "Although the risk for FG is low, serious infection should be considered and weighed against the benefits of SGLT2-inhibitor therapy."

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