FDA Warns of Rare Genital Infection with Certain Diabetes Drugs

By Kelly Young

Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD

Sodium-glucose cotransporter-2 (SGLT2) inhibitors, approved to treat type 2 diabetes, may be associated with a rare risk for necrotizing fasciitis of the perineum, orFournier's gangrene, the FDA cautioned.

From 2013 to 2018, the FDA has identified 12 cases of Fournier's gangrene among patients using SGLT2 inhibitors, seven were men and five were women. Fournier's gangrene is usually diagnosed in men. All of the cases had recently started an SGLT2 inhibitor. All patients were hospitalized and had surgery. One patient died.

The FDA acknowledges there may be more cases that have gone unreported.

Patients taking an SGLT2 inhibitor (e.g., canagliflozin, dapagliflozin, empagliflozin, ertugliflozin) should seek medical care if they notice tenderness, redness, or swelling in the area of the genitals or perineum and have a fever over 100.4 degrees Fahrenheit or feel generally unwell. If Fournier's gangrene is suspected, clinicians should discontinue SGLT2 inhibitor treatment, immediately start the patient on broad-spectrum antibiotics, and perform surgical debridement as necessary.