Pharmacy Services Alerts
SGLT2 Inhibitors May Increase Risk of Rare Perineal Infection in Diabetes Patients
Sep 10, 2018 10:06 AM
On August 29, 2018, FDA issued a warning that sodium-glucose cotransporter-2 (SGLT2) inhibitors are linked to a rare but serious infection of the genital area, known as necrotizing fasciitis of the perineum. This infection, also known as Fournier gangrene, causes life-threatening destruction and necrosis of subcutaneous tissues surrounding the blood vessels, fat, muscles, and nerves of the perineum. The SGLT2 inhibitors are labeled to improve glycemic control in adults with type 2 diabetes. Available SGLT2 inhibitors include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. FDA identified 12 cases of Fournier gangrene associated with SGLT2 inhibitors between March 2013 and March 2018. All 12 patients required hospitalization and surgery, and 1 patient died as a result. Among other antidiabetic agents, there are only 6 reported cases of Fournier gangrene in over 30 years. FDA is requiring updates to the prescribing information and medication guides for all SGLT2 inhibitors.
Patients should see a provider immediately if they have redness, swelling, or tenderness of the genital area or the perineum, and fever above 100.4˚ F or a general feeling of unwellness. Patient condition may change rapidly so recognition and treatment are vital. Health care professionals should assess all patients presenting with these symptoms for Fournier gangrene. Start broad-spectrum antibiotics immediately and discontinue any SGLT2 inhibitor if Fournier gangrene is suspected. Continue to closely monitor blood glucose and manage hyperglycemia with alternate therapy. Patients and healthcare professionals are encouraged to report any side effects involving SGLT2 inhibitors or other medications to the FDA MedWatch program.
More information can be found in the following links:
- FDA Drug Safety Report link:
- MedWatch Safety Report link: