FDA Mandates Label Changes With New Warnings For Invokana, Farxiga, Jardiance, Other SGLT2 Inhibitors
In late August 2018 the FDA warned doctors and patients that cases of Fournier’s gangrene, a rare but serious infection of the genitals and area around the genitals, have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. More specifically, this serious rare infection is called necrotizing fasciitis of the perineum.
Oral diabetes medicines included in this SGLT2 inhibitors drug class are Invokana, Farxiga, and Jardiance, as well as Invokamet, Xigduo, Glyxambi, Synjardy, Qtern, Steglatro, Steglujan, and Segluromet.
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 the other SGLT2 inhibitor diabetes drugs:
Strictly Confidential, No Obligation.
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.
In the Additional Information for Patients part of that FDA document there is this important point:
- Seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly.
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.
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