Anew analysis from the FDA has found that use of sodium-glucose cotransporter-2 (SGLT2) inhibitors is associated with increased risk for Fournier gangrene (FG), a rare urologic necrotizing infection.
The FDA previously issued a warning about the potential association in 2018.
To examine this relationship, they examined data from the FDA Adverse Event Reporting System and from published case reports. Overall, they identified 55 cases of FG in patients treated with SGLT2 inhibitors between March 1, 2013 and January 31, 2019. The time to onset of FG following start of SGLT2 inhibitors ranged from 5 days to 49 months. Three of the patients died.
For comparison, 19 cases of FG were identified between 1984 and January 31, 2019. These cases were associated with metformin (n = 8), insulin glargine (n = 6), short-acting insulin (n = 2), sitagliptin plus metformin (n = 2), and dulaglutide (n = 1). Of these, 2 patients died.
“FG is a newly identified safety concern in patients receiving SGLT2 inhibitors. Physicians prescribing these agents should be aware of this possible complication and have a high index of suspicion to recognize it in its early stages,” they concluded.
Bersoff-Matcha SJ, Chamberlain C, Cao C, et al. Fournier gangrene associated with sodium–glucose cotransporter-2 inhibitors: a review of spontaneous postmarketing cases [published online May 7, 2019]. Ann Intern Med. DOI: 10.7326/M19-0085.