FDA Issues Warning for Genital Infection Caused by SGLT2 Inhibitors

The US Food and Drug Administration (FDA) has released a warning on cases of rare, serious genital area infections having been reported with sodium-glucose contransporter-2 (SGLT2) inhibitors.

SGLT2 inhibitors, a class of drugs indicated for use with diet and exercise in patients with type 2 diabetes (T2D), has been linked to necrotizing fasciitis of perineum (Fournier’s gangrene). The FDA will now require a new warning regarding this risk be added to the prescribing information of all SGLT2 inhibitors, as well as to the patient Medication Guide.

First approved by the FDA in 2013, SGLT2 inhibitors such as canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin have been valued by clinicians and physicians for their ability to remove sugar from the body of patients with T2D through urination. Specific drugs such as empagliflozin have also been approved to lower the mortality risk of heart attacks and strokes in adult patients with T2D and heart disease.

The FDA is currently advising healthcare providers assess patients for Fournier’s gangrene if they present with symptoms. Treatment should begin immediately for suspected patients, with broad-spectrum antibiotics and surgical debridement as primary options.

The administration also advises discontinuation of the inhibitor class, with alternative therapies and more closely-monitored blood glucose levels serving in their place.

Symptoms of the rare infection include tenderness, redness, or genital swelling that includes the area from the genitals back to the rectum, as well as fevers above 100.4 F or a general feeling of illness.