Fournier's gangrene is a rare but potentially life-threatening bacterial infection of the tissue underlying the skin surrounding the perineal muscles, nerves, fat, and blood vessels.
Prescribers should advise patients taking SGLT2 inhibitors to seek medical attention immediately if they experience symptoms such as severe pain, tenderness, erythema or swelling in the genital or perineal area accompanied by fever or malaise.
If Fournier’s gangrene is suspected, the SGLT2 inhibitor should be stopped and appropriate treatments should be started immediately.
The MHRA says it has received 6 Yellow Card reports of UK cases of Fournier’s gangrene in patients on SGLT2 inhibitors up to January 2019. Of these cases, 4 were in men and 2 were in women.