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FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.

On August 29, 2018, FDA warned that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (or SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. We are requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. They lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin.

Health care professionals should assess patients for Fournier’s gangrene and if suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary. Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.

Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. Published literature about the occurrence of Fournier’s gangrene for men and women is limited, with reported occurrence in 1.6 out of 100,000 males annually in the U.S., most frequently in males 50-79 years of age.

From March 2013 to May 2018, we identified 12 cases, 7 men and 5 women, of Fournier’s gangrene in patients taking an SGLT2 inhibitor. This includes only reports submitted to FDA and found in the medical literature, so there may be additional cases about which we are unaware. Fournier’s gangrene developed within months of patients starting an SGLT2 inhibitor. All 12 patients were hospitalized and required surgery. In comparison, only six cases of Fournier’s gangrene (all in men) were identified in review of other antidiabetic drug classes over a period of more than 30 years.

Side effects involving SGLT2 inhibitors should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete data summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

Thank you for listening.

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