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SGLT2i, Topics

August 30, 2018

New FDA SGLT2i Warning For Rare Genital Infections

Here is a brief preview of this blast: FDA issued a warning for the risk of a rare genital infection (necrotizing fasciitis of the perineum aka Fournier’s gangrene) with the use of SGLT2 inhibitors. FDA is also requiring label updates for the class. According to the FDA’s warning letter, there have been 12 cases (7 males and 5 females) of Fournier’s gangrene from March 2013 to May 2018.