FDA Warning: Fournier Gangrene and SGLT2 Inhibitors

A case series suggests higher risk for perineal necrotizing fasciitis with sodium–glucose cotransporter 2 inhibitor antidiabetic medications.

Fournier gangrene (FG) is a rare necrotizing fasciitis of the perineal soft tissue and organs with high rates of complications (e.g., fecal diversion) and death and prolonged recovery times. Although approximately half of cases are in patients with diabetes, specific triggers of this disease are not identifiable. FDA investigators queried the organization's Adverse Event Reporting System, in addition to searching several comprehensive medical databases, to identify all reported cases of FG in diabetic patients who received sodium–glucose cotransporter 2 (SGLT2) inhibitors (e.g., empagliflozin [Jardiance], canagliflozin [Invokana]) since their FDA-approval in 2013 and any reported cases of FG in diabetic patients who received other hypoglyce…

Reviewing Author

Daniel D. Dressler, MD, MSc, SFHM, FACP

Disclosures

RoyaltiesMcGraw-Hill; Elsevier

Editorial BoardsMedical Clinics of North America; Caribbean Medical Journal International Advisory Panel (2021–2026)

Daniel D. Dressler, MD, MSc, SFHM, FACP

Disclosures

RoyaltiesMcGraw-Hill; Elsevier

Editorial BoardsMedical Clinics of North America; Caribbean Medical Journal International Advisory Panel (2021–2026)

FDA Warning: Fournier Gangrene and SGLT2 Inhibitors

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Reviewing Author