Sodium-glucose cotransporter 2 (SGLT-2) inhibitors used to treat adults with type 2 diabetes have been linked with necrotizing fasciitis of the perineum, a serious rare infection also known as Fournier gangrene, the FDA has warned.
Agency officials said that between March 2013 and May 2018 they identified 12 cases of Fournier gangrene in patients taking an SGLT-2 inhibitor. But those cases include only reports submitted to the FDA or published in the medical literature; the actual number of cases could be greater. In comparison, the FDA said only 6 cases of Fournier gangrene were linked with other antidiabetic drug classes over more than 30 years.
Infections developed in all 12 patients within several months of starting an SGLT-2 inhibitor. All were hospitalized and required surgery that in some was disfiguring or resulted in complications. One patient died. In 2017, an estimated 1.7 million patients received a dispensed prescription for an SGLT-2 inhibitor from US outpatient retail pharmacies.
First approved in 2013, medications in the SGLT-2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. Empagliflozin also is approved to reduce the risk of dying of myocardial infarction or stroke among patients with type 2 diabetes and heart disease. Fournier gangrene is a life-threatening bacterial infection of the tissue under the skin surrounding the muscles, nerves, fat, and blood vessels of the perineum. Symptoms include genital tenderness, redness, or swelling and temperature higher than 100.4°F.
The FDA said it is requiring manufacturers to add a new warning to the prescribing information and patient medication guide for all SGLT-2 inhibitors.
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