This article is more than 5 years old. Information may no longer be current.
Fournier gangrene associated with SGLT2 inhibitors use
Fournier gangrene, also known as necrotizing fasciitis of the perineum, is a safety concern in patients who receive sodium-glucose cotransporter-2 inhibitors, according to new study findings published in the Annals of Internal Medicine.
“Previous studies describing [Fournier gangrene] implicated diabetes as a major risk factor,” Susan J. Bersoff-Matcha, MD, of the FDA, and colleagues wrote. “Although diabetes is common, [Fournier gangrene] is very rare, with an overall incidence of 1.6 in 100,000 males and a peak incidence of 3.3 in 100,000 men aged 50 to 79 years.”
Researchers used the FDA Adverse Event Reporting System (FAERS) database to identify cases of Fournier gangrene in patients receiving SGLT2 inhibitors. All reports of Fournier gangrene between Mar. 1, 2013, and Jan. 31, 2019 in patients receiving SGLT2 inhibitors at the time of diagnosis. Patients had a necrotizing infection of the perineum and received surgical debridement to treat the infection.
In addition, researchers used PubMed, Google Scholar, EMBASE, and EBSCOhost to search for case reports, case series, and epidemiologic studies that reported on Fournier gangrene and SGLT2-inhibitor therapy.
The FAERS search yielded 183 reports of Fournier gangrene associated with SGLT2 inhibitors, 55 of which were included in study results. Patients were a median age of 56 years, 39 were male, and 44 cases occurred in the United States. Three patients died, and all patients were severely ill and hospitalized. The time to onset after starting SGLT2 inhibitors ranged from 5 days to 49 months.
Among patients, at least 25 required more than one procedure and one required 17 visits to the operating room. Operations included fecal diversion surgery (n = 8), amputation of a lower extremity due to development of necrotizing fasciitis in a lower extremity (n = 2), and lower extremity bypass procedure due to gangrenous toes (n = 1). Patients reported adverse events including diabetic ketoacidosis (n = 8), sepsis or septic shock (n = 9), and acute kidney injury (n = 4).
Researchers also searched FAERS to find cases of Fournier gangrene with anti-glycemic agents other than SGLT2 inhibitors. They found 19 Fournier gangrene cases associated with use of other anti-glycemics such as metformin, insulin glargine, and short-acting insulin from 1984 to Jan. 31, 2019. Two patients died and were aged 42 to 79 years.
“Awareness of the association between [Fournier gangrene] and SGLT2 inhibitor use may be an important factor in an informed prescriber-patient discussion regarding appropriate diabetes therapy,” Bersoff-Matcha and colleague wrote. “Although the risk for [Fournier gangrene] is low, serious infection should be considered and weighed against the benefits of SGLT2-inhibitor use.” – by Erin Michael
Disclosures: The authors report no relevant financial disclosures.