FDA Warns of Genital Gangrene Associated with SGLT2 Inhibitors for Type II Diabetes

After increasing incidents of necrotizing fasciitis of the perineum reported among Type II diabetic patients taking sodium-glucose cotransporter-2 (SGLT2) inhibitors, the FDA is requiring the risk to be added to the prescribing information. The infection, commonly called Fournier’s gangrene, is rare but potentially lethal. The bacteria usually enter the body through a cut in the skin, and quickly spreads and destroys the surrounding muscles, nerves, fat, and blood vessels of the perineum.

From 2013 to 2018, the FDA identified 12 cases of Fournier’s gangrene that developed shortly after the patients were prescribed SGLT2 inhibitors. Of these cases, 7 were men and 5 were women, all of whom required hospitalization and surgery. Some patients were left disfigured or with lingering complications, and one of the patients died. In contrast, only 6 cases of the infection were identified during a span of 30 years when reviewing other antidiabetic drug classes. While there is little research into the infection, the published reports suggest that it occurs in 1.6 out of 100,000 men, most commonly in men from 50 to 79 years of age.

Patients taking a SGLT2 inhibitor should seek medical attention immediately if they experience any tenderness, redness, or swelling of the genitals to the rectum, and if they have a fever that exceeds 100.4, or even if they just have a general feeling of being unwell.  Doctors can then cease the medication and start a treatment of antibiotics, potentially accompanied by surgical removal of the infection.

Some of the brand names for FDA approved SGLT2 inhibitors are: Invokana, Invokamet (XR), Farxiga, and Qtern. For a full list of medications, or to report side effects involving SGLT2 inhibitors, please go to link below. Unfortunately, this is another instance of unintended side effects from pharmaceuticals.

https://www.fda.gov/Drugs/DrugSafety/ucm617360.htm