Certain medications used to treat diabetes have been linked to cases of a rare, potentially deadly flesh-eating genital infection, the Food and Drug Administration announced this week.
The medications affected: sodium-glucose cotransporter-2 (SGLT2) inhibitors, which are used in the treatment of type 2 diabetes. A Wednesday release from the FDA lists more than a dozen drugs that will have to warn of the infection. Among the brand names listed: Invokana, Farxiga and Jardiance.
The infection that prompted the warning is "necrotizing fasciitis of the perineum," also called "Fournier’s gangrene." The rare infection affects the genital region and has a mortality rate of more than 20 percent, according to a 2012 study published by ISRN Surgery and US National Library of Medicine.
Necrotizing fasciitis is a rare bacterial infection commonly known as “flesh eating bacteria," according to the Centers for Disease Control and Prevention.
The warning comes after the FDA identified 12 cases of the disease in patients taking an SGLT2 inhibitor over the course of 5 years, between March 2013 to May 2018. That's compared to only six recorded cases in more than 30 years in patients taking other antidiabetic drug classes, the FDA says.
Of the 12 cases studied, all patients required surgery, with some surgeries disfiguring in nature. One patient died, the FDA reported.
The FDA's warning urges patients to seek medical treatment if they experience "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."
SGLT2 inhibitors were first approved by the FDA in 2013 and are used, with diet and exercise, to help lower blood sugar in patients with type 2 diabetes, the FDA says.
"Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease," according to the FDA.