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FDA Warns Of Link Between Flesh-Eating Genital Infection And Diabetes Medicines

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The U.S. Food and Drug Administration has warned that certain medications prescribed for people with diabetes have been linked to cases of potentially deadly flesh-eating genital infection.

SGLT2 Inhibitors

In a statement released on Aug. 29, FDA said that cases of a rare infection of the genitals and crotch have been reported with use of a class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors.

SGLT2 inhibitors are approved by the FDA for use, along with exercise and diet, to lower blood sugar levels in adults with type 2 diabetes. The drugs work by causing the kidney to remove sugar from the body through the urine.

Invokana, Invokamet XR, Steglatro, Farxiga, Synjardy, Synjardy XR, Xigduo XR, Qtern, Invokamet, Jardiance, Glyxambi, Segluromet, and Steglujan are brand names of SGLT2 inhibitors green-lighted by health regulators.

SGLT2 Inhibitors And Fournier's Gangrene

From March 2013 to May 2018, health regulators were able to identify 12 cases of Fournier's gangrene in people prescribed to take SGLT2 inhibitor.

Fournier's gangrene, or necrotizing fasciitis of the perineum, typically occurs when bacteria enters the body through a cut or break in the skin. The condition is fatal in 20 to 30 percent of the cases.

FDA said that Fournier's gangrene developed several months after the patients started SGLT2 inhibitor. All 12 patients were hospitalized and had to undergo surgery. Some needed multiple disfiguring surgeries and complications. One patient died.

The 12 cases include only those reported and those in the medical literature, which means that there are possibly more unidentified cases.

In comparison, a review found there were only six identified cases of Fournier's gangrene in patients taking other classes of diabetes drugs over a 30-year period. All of these six cases occurred in men, but five of the 12 cases linked to SGLT2 inhibitors involved women.

New Warning

The FDA now requires that a new warning about the risk for Fournier's Gangrene be added to the prescribing information of SGLT2 inhibitors and the medication guide for patients.

The agency advised patients taking the drug to seek medical attention as soon as possible if they notice redness or swelling of the genitals or the area from the genitals to the rectum, and if they have a fever above 100.4 F.

It also urged healthcare professionals to check their patients for potential symptoms of Fournier's gangrene.

"If suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary. Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control," the FDA said.

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