The FDA this week warned of serious flesh-eating bacterial infections, or necrotizing fasciitis, reported by patients taking sodium-glucose cotransporter-2 (SGLT2) inhibitors intended for treating type 2 diabetes.
The federal watchdog said that between March 2013 and May 2018, 12 cases of Fournier’s gangrene, a rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat and blood vessels of the perineum, were reported by users of the drug.
The FDA said that a single patient was reported to have died from the infection, and that all patients were hospitalized and required surgery, with some requiring “multiple disfiguring surgeries.”
The drugs are produced by Johnson & Johnson‘s (NYSE:JNJ) Ivokana, Eli Lilly‘s (NYSE:LLY) Jardiance, Bristol-Myers Squibb (NYSE:BMY), Astra Zeneca (NYSE:AZN), Merck (NYSE:MRK) and Pfizer (NYSE:PFE), according to a Reuters report, which said that the producing companies had not yet responded to a request for comment.
The FDA said that SGLT2 inhibitors are approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes, and that the inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.
The agency said that any patients experiencing symptoms of tenderness, redness or swelling of the genitals or area from the genitals to the back of the rectum on the drug seek medical attention immediately.
The federal watchdog said that it is requiring a new warning be added to labels of the drug.