FDA Officials Warn About Potential for Genital Infection Caused by Certain Diabetes Drugs

FDA officials are requiring a warning about this on the prescription information.

Officials with the US Food and Drug Administration (FDA) have released a warning on cases of rare, serious genital area infections having been reported with sodium-glucose contransporter-2 (SGLT2) inhibitors, and are now requiring a warning regarding this risk be added to the prescribing information.

SGLT2 inhibitors, a class of drugs indicated for use with diet and exercise in patients with type 2 diabetes (T2D), has been linked to necrotizing fasciitis of perineum (Fournier’s gangrene).

First approved by the FDA in 2013, SGLT2 inhibitors such as canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin have been valued by clinicians and physicians for their ability to remove sugar from the body of patients with T2D through urination. Specific drugs such as empagliflozin have also been approved to lower the mortality risk of heart attacks and strokes in adult patients with T2D and heart disease.

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