From this August 29, 2018 Drug Safety Communication, “FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes”, we get the following details about this new safety issue for Invokana, Farxiga, Jardiance, and similar diabetes drugs:
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….
In the five years from March 2013 to May 2018, we identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor…. Although most cases of Fournier’s gangrene have previously been reported in men, our 12 cases included 7 men and 5 women. Fournier’s gangrene developed within several months of the patients starting an SGLT2 inhibitor and the drug was stopped in most cases. All 12 patients were hospitalized and required surgery. Some patients required multiple disfiguring surgeries, some developed complications, and one patient died. 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.
We have started investigating possible drug injury lawsuits for patients diagnosed with necrotizing fasciitis of the perineum, also referred to as Fournier’s gangrene, while using Invokana, Jardiance, Farxiga, or one of the other SGLT-2 inhibitor diabetes drugs.[Read article in full at original source]
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