UNITED STATES – As reported in an online article published by Infectiousdiseaseadvisor.com, patients taking SGLT2 inhibitors to treat type 2 diabetes may be at risk of developing Fournier’s Gangrene, an infection of the genital area.
According to study results published in the Annals of Internal Medicine, infections of the genital area such as Fournier’s Gangrene and urinary tract infections are the most common adverse events reported in clinical trials evaluating the use of SGLT2 inhibitors to treat type 2 diabetes. While Fournier’s Gangrene is rare, study results reveal that in 33% to 66% of cases of Fournier’s Gangrene, the patients with the genital infection also had type 2 diabetes.
Additionally, a review of the United States Food and Drug Administration’s (FDA) adverse event reporting system between March 2013 and January 2019 as well as other sources identifying adverse events, reveal a total of 55 cases of Fournier’s Gangrene in patients who were taking SGLT2 inhibitors for the treatment of type 2 diabetes. Patients ranged in age from 33 years old to 87 years old, and the average time the patients took SGLT2 inhibitors was 9 months (with a range of 5 days of usage to 49 months of usage).
In each of the 55 cases of patients with Fournier’s Gangrene, all of them were severely ill and hospitalized. Some of these patients also experienced additional complications, including diabetic ketoacidosis (DKA) and sepsis.
In 2 cases, patients underwent amputation of a lower extremity because of necrotizing fasciitis. In 8 cases, patients underwent a procedure for fecal diversion. In 3 cases, patients died, although, the specific details of the 3 deaths are not clear. While 55 patients were identified as having been diagnosed with Fournier’s Gangrene, the total number of patients with this condition that were taking SGLT2 inhibitors to treat type 2 diabetes may be much higher as many cases are unreported.
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