The FDA is mandating a new warning label on all sodium-glucose cotransporter-2 (SGLT2) inhibitors after the drugs were linked to 12 cases of Fournier’s gangrene in diabetic patients over the past five years.
Fournier’s gangrene, also known as necrotizing fasciitis of the perineum, is “rare but serious,” according to an FDA statement. It develops when life-threatening bacteria find their way into peoples’ bodies through cuts or breaks in the skin, at which point they spread and start infecting nearby tissue.
Diabetes is a risk factor for the condition, officials said, though it remains highly uncommon in diabetics. Past research has estimated around 1.6 in 100,000 men living in the U.S. will develop Fournier’s gangrene over the course of a year.
SGLT2 inhibitors are FDA-approved to manage that risk, and it’s been that way since 2013. Medicines like canagliflozin, dapagliflozin, empagliflozin and ertugliflozin are all approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.
Still, the FDA said a recent review of cases of Fournier’s reported to the FDA or documented in medical literature between 2013 and 2018 found 12 cases of gangrene among 1.7 million patients who received a dispensed prescription for an SGLT2 inhibitor from U.S. outpatient retail pharmacies. Though most cases of the disease are found in men, the FDA’s review found five cases in women.
All patients were hospitalized and required surgery—sometimes disfiguring and oftentimes complicated—according to the statement. One patient died.
Officials said healthcare professionals and patients alike need to keep an eye out for symptoms of the illness, including redness and swelling around the genitals and a fever above 100.4 degrees Fahrenheit. If doctors identify Fournier’s, the FDA recommends discontinuing the inhibitor immediately and replacing it with broad-spectrum antibiotics and alternative therapy for glycemic control.
“These symptoms can worsen quickly, so it is important to seek treatment right away,” officials wrote.