FDA Warns of Serious Genital Infection With SGLT2 Inhibitors


The US Food and Drug Administration (FDA) is warning about cases of necrotizing fasciitis of the perineum in patients taking sodium-glucose cotransporter-2 (SGLT2) inhibitors.

The new warning will be added to the prescribing information and the patient medication guides for all single and combination agents in the glucose-lowering SGLT2 inhibitor class of drugs approved to treat type 2 diabetes. Those drugs include the following:

  • Canagliflozin (Invokana, Invokamet, Invokamet XR; Janssen)

  • Dapagliflozin (Farxiga, Xigduo XR, Qtern, AstraZeneca

  • Empagliflozin (Jardiance, Glyxambi, Synjardy, Synjardy XR; Boehringer Ingelheim/Eli Lilly)

  • Ertugliflozin (Steglatro, Segluromet, Stelujan; Merck)

Necrotizing fasciitis of the perineum, also called Fournier’s gangrene, is an extremely rare but life-threatening bacterial infection of the tissues underlying the skin surrounding the perineal muscles, nerves, fat, and blood vessels.

Patients taking SLGT2 inhibitors should be advised to seek medical attention immediately if they experience tenderness, redness, or swelling of the genitals or the area from the genitals to the rectum and have a temperature higher than 100.4° F.

Healthcare professionals should assess patients for Fournier’s gangrene if they present with tenderness, erythema, swelling in the genital or perineal area, fever, malaise, and have pain out of proportion to the physical examination.

If the condition is suspected, broad-spectrum antibiotics should be started immediately, and surgical debridement performed if necessary. The SGLT2 inhibitor should be discontinued, the patient’s blood glucose levels should be carefully monitored, and alternative blood glucose-lowering medications should be provided.

Culled from MedScape NEWS

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