The FDA warned on Aug. 29 that cases of a rare, serious infection of the genitals and surrounding area have been reported in patients taking sodium-glucose cotransporter-2 (SGLT2) inhibitors. The agency is requiring that a new warning about this risk be added to the prescribing information of all SGLT2 inhibitors, as well as to the patient medication guide.
From March 2013 to May 2018, the agency identified 12 cases of the infection, called necrotizing fasciitis of the perineum or Fournier's gangrene, in seven men and five women. The infection developed within several months of the patients starting an SGLT2 inhibitor, and the drug was discontinued in most cases. All 12 patients were hospitalized and required surgery, some developed complications, and one died.
The FDA recommends that patients taking SGLT2 inhibitors seek immediate medical attention if they experience tenderness, redness, or swelling of the genitals or the area from the genitals to the rectum in addition to a fever above 100.4 °F or a general feeling of being unwell. If a clinician suspects a patient has Fournier's gangrene, he or she should immediately begin treatment with broad-spectrum antibiotics and surgical debridement, if necessary, as well as discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.