1. In this descriptive case series, 55 cases of patients with diabetes who developed Fournier gangrene while using sodium-glucose cotransporter-2 (SGLT2) inhibitors are described.
2. While neither causality nor incidence are identified in this paper, physicians prescribing SGLT2 inhibitors should be aware of the association with Fournier gangrene.
Evidence Rating Level: 4 (Below Average)
Study Rundown: Fournier gangrene (FG) is a rapidly progressive necrotizing fasciitis of the perineum, external genitalia, and perianal region that requires immediate broad-spectrum antibiotics and surgical intervention. While some risk factors such as HIV status, alcoholism, and diabetes mellitus (DM) have been described, FG is extremely rare and remains poorly understood. Recently, the FDA issued warnings that sodium-glucose cotransporter-2 (SGLT2) medications for DM could be associated with FG. This study reviewed and described 55 reported cases of adults who developed FG while also taking SGLT2 inhibitors. The time from initiation of SGLT2 and FG onset were variable, as were associated complications. As this study was purely descriptive, there were many limitations. There was no establishment of causality or incidence. Further, the data was limited by the voluntary nature of incident reporting, thus leading to variable quality of the reports, underreporting, and confounding by indication.
Click to read the study in Annals of Internal Medicine
Relevant Reading: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
In-Depth [descriptive case-series]: The authors used the FDA Adverse Event Reporting System (FAERS), a database of adverse drug events voluntarily reported by health care providers, as well as published cases reports, to identify 55 cases of FG after SGLT2 therapy. Age of patients ranged from 33-87 years, with 39 men and 19 women. Time from initiation of SGLT2 therapy to development of FG ranged from 5 days to 49 months. Common complications in the order of prevalence included sepsis (n=9), diabetic ketoacidosis (n=8), fecal diversion surgery (n=8), acute kidney injury (n=4), and death (n=3). Comparatively, only 19 cases of FG associated with other antiglycemic agents were identified by the FDA between 1984 and 2019. The patients were between the ages of 42 and 79, and were on metformin (n=8), short-acting insulin (n=2), insulin glargine (n-6) and dulaglutide (n=1). Of these patients, two died. The results of this study showed that in patients receiving SGLT2 inhibitors, physicians should be aware of complications such as FG and be able to diagnose them during their early stages.
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