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News From the Food and Drug Administration
October 2, 2018

Rare Infection Linked With SGLT-2 Inhibitor Use

JAMA. 2018;320(13):1309. doi:10.1001/jama.2018.14128

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.