Bao Anh Tran1, Wendy H Updike1,2, Krystal Bullers3, Erini Serag-Bolos1. 1. Department of Pharmacotherapeutics & Clinical Research, Taneja College of Pharmacy, University of South Florida, Tampa, FL. 2. Department of Family Medicine, Morsani College of Medicine, University of South Florida, Tampa, FL. 3. Univeristy of South Florida Health Libraries, Tampa, FL.
Abstract
BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors are effective for glycemic control and have demonstrated cardiorenal benefits. The U.S. Food and Drug Administration (FDA) released a boxed warning in 2018 regarding the potential development of Fournier's gangrene (FG) with the use of SGLT2 inhibitors. FG is a serious perineal infection with a mortality rate of up to 88% in some cases. OBJECTIVES: To report spontaneous post-marketing cases from the FDA Adverse Event Reporting System (FAERS) database and case reports from the literature of FG associated with the use of SGLT2 inhibitors and to determine whether correlations exist with specific agents. METHODS: A search of the FAERS database was conducted to identify reported cases of FG associated with the use of any FDA-approved SGLT2 inhibitor between 1 March 2013 and 30 June 2020. Additionally, a literature search was conducted of PubMed, Embase, and the Cochrane library using PRISMA guidelines to identify case reports of FG with the use of SGLT2 inhibitors up to 9 October 2020. RESULTS: A total of 491 cases from the FAERS database were included for review. Descriptive analysis depicted more cases in the empagliflozin, canagliflozin, and dapagliflozin groups than in the ertugliflozin group. Nine case reports were included from the literature review; four attributed to dapagliflozin, three to empagliflozin, and two to canagliflozin. The median ages from cases reported in the FAERS database and from the literature review were 54 and 52 years, respectively. In both datasets, males had a higher incidence of FG than females. Additional data reported include clinical outcomes and concomitant antihyperglycemic medications. CONCLUSION: Consistent findings are noted in this systematic review and warrant further investigation to elucidate the association between SGLT2 inhibitor use and the development of FG. These results may drive enhanced prescribing patterns to consider patient-specific risk factors and timely monitoring, especially as more indications are approved related to these medications' cardiorenal protective properties.
BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors are effective for glycemic control and have demonstrated cardiorenal benefits. The U.S. Food and Drug Administration (FDA) released a boxed warning in 2018 regarding the potential development of Fournier's gangrene (FG) with the use of SGLT2 inhibitors. FG is a serious perineal infection with a mortality rate of up to 88% in some cases. OBJECTIVES: To report spontaneous post-marketing cases from the FDA Adverse Event Reporting System (FAERS) database and case reports from the literature of FG associated with the use of SGLT2 inhibitors and to determine whether correlations exist with specific agents. METHODS: A search of the FAERS database was conducted to identify reported cases of FG associated with the use of any FDA-approved SGLT2 inhibitor between 1 March 2013 and 30 June 2020. Additionally, a literature search was conducted of PubMed, Embase, and the Cochrane library using PRISMA guidelines to identify case reports of FG with the use of SGLT2 inhibitors up to 9 October 2020. RESULTS: A total of 491 cases from the FAERS database were included for review. Descriptive analysis depicted more cases in the empagliflozin, canagliflozin, and dapagliflozin groups than in the ertugliflozin group. Nine case reports were included from the literature review; four attributed to dapagliflozin, three to empagliflozin, and two to canagliflozin. The median ages from cases reported in the FAERS database and from the literature review were 54 and 52 years, respectively. In both datasets, males had a higher incidence of FG than females. Additional data reported include clinical outcomes and concomitant antihyperglycemic medications. CONCLUSION: Consistent findings are noted in this systematic review and warrant further investigation to elucidate the association between SGLT2 inhibitor use and the development of FG. These results may drive enhanced prescribing patterns to consider patient-specific risk factors and timely monitoring, especially as more indications are approved related to these medications' cardiorenal protective properties.
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