Sodium-glucose cotransporter-2 (SGLT2) inhibitors are associated with increased risk for Fournier gangrene, according to an FDA analysis published in the Annals of Internal Medicine. The agency first issued a warning about the potential association in 2018.
In the 6 years after SGLT2 inhibitors were first approved, some 55 cases of Fournier gangrene were reported in treated patients. Diagnostic criteria included necrotising infection of the perineum plus surgical debridement. In contrast, just 19 cases were reported over 35 years in patients taking other diabetes drugs.
Here are some details of the cases associated with SGLT2 inhibitors:
• Roughly 70% were in men.
• The time from treatment initiation to Fournier gangrene ranged from 5 days to 49 months.
• Complications included diabetic ketoacidosis, sepsis, and kidney injury.
• Eight patients underwent faecal diversion surgery, and two patients developed necrotising fasciitis of a lower extremity that led to amputation.
• Three patients died.
The researchers conclude that clinicians “should be aware of this possible complication and have a high index of suspicion to recognise it in its early stages.”