US-FDA warning: increased risk of Fournier's gangrene with SGLT2 inhibitors

The US-FDA has issued a warning regarding increased risk of Fournier's gangrene with use of SGLT2 inhibitors in treatement of type 2 diabetes mellitus. This class of drugs includes canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. SGLT2 inhibitors act on the sodium-glucose cotransporter 2, inhibiting proximal tubular reabsorption of glucose - thus promoting renal excretion. The increased urinary glucose levels however are linked to a increased risk of vulvovaginal candidiasis (~10% patients) and urinary tract infections.

Twelve cases of Fournier's gangrene (necrotizing fasciitis of the perineum) were reported to the FDA adverse event reporting system over a period of 5 years. In contrast, only 6 cases were reported for other anti-diabetic medication classes over a period of 34 years. The SGLT2 linked cases affected both men and women, while the non-SGLT2 cases affected only men. The FDA recommends discontinuation of SGLT2 inhibitors in patients with suspected Fournier's gangrene. The full warning can be accessed at https://www.fda.gov/Drugs/DrugSafety/ucm617360.htm.