“…Although the incidence of reported cases was low, this observation prompted a warning in the Summary of Product Characteristics of all FDA‐approved SGLT2i (canagiflozin, dapagliflozin, empagliflozin and ertugliflozin). In the meantime, four cases of FG associated with SGLT2i have been published …”
Section: Introductionmentioning
confidence: 99%
“…In the meantime, four cases of FG associated with SGLT2i have been published. [4][5][6][7] SGLT2i are associated with an increase in the risk of genital infections, usually mild, and with a modest increase in infections of the lower urinary tract, 8 whereas there is no clear association of these drugs with skin infections.…”
Fournier's gangrene (FG) is a rare, life‐threatening necrotizing fasciitis of the perineum. The US Food and Drug Administration (FDA) released a Drug Safety Communication regarding the risk of FG associated with sodium‐glucose co‐transporter‐2 inhibitors (SGLT2i), relying on the FDA Adverse Event Reporting System. To verify this association, we performed a meta‐analysis of all randomized controlled trials enrolling patients with type 2 diabetes, comparing SGLT2i with placebo or different therapies, collecting cases of FG reported as a serious adverse event. Risk of abscess, cellulitis and erysipela were secondary outcomes. We retrieved 84 trials enrolling 42 415 patients in the SGLT2i group and 27 158 patients in comparator groups. No difference was observed between SGLT2i and comparators in the risk of FG (Mantel‐Haenzel odds ratio [MH‐OR] 0.41 [0.09, 1.82]), abscess (MH‐OR 0.94 [0.54, 1.65]), cellulitis (MH‐OR 0.90 [0.71, 1.13] or erysipela (MH‐OR 0.89 [0.45, 1.77]). The number of events was small, leading to a wide confidence interval that does not allow ruling out an increase in FG or skin and subcutaneous tissue infections.
“…Although the incidence of reported cases was low, this observation prompted a warning in the Summary of Product Characteristics of all FDA‐approved SGLT2i (canagiflozin, dapagliflozin, empagliflozin and ertugliflozin). In the meantime, four cases of FG associated with SGLT2i have been published …”
Section: Introductionmentioning
confidence: 99%
“…In the meantime, four cases of FG associated with SGLT2i have been published. [4][5][6][7] SGLT2i are associated with an increase in the risk of genital infections, usually mild, and with a modest increase in infections of the lower urinary tract, 8 whereas there is no clear association of these drugs with skin infections.…”
Fournier's gangrene (FG) is a rare, life‐threatening necrotizing fasciitis of the perineum. The US Food and Drug Administration (FDA) released a Drug Safety Communication regarding the risk of FG associated with sodium‐glucose co‐transporter‐2 inhibitors (SGLT2i), relying on the FDA Adverse Event Reporting System. To verify this association, we performed a meta‐analysis of all randomized controlled trials enrolling patients with type 2 diabetes, comparing SGLT2i with placebo or different therapies, collecting cases of FG reported as a serious adverse event. Risk of abscess, cellulitis and erysipela were secondary outcomes. We retrieved 84 trials enrolling 42 415 patients in the SGLT2i group and 27 158 patients in comparator groups. No difference was observed between SGLT2i and comparators in the risk of FG (Mantel‐Haenzel odds ratio [MH‐OR] 0.41 [0.09, 1.82]), abscess (MH‐OR 0.94 [0.54, 1.65]), cellulitis (MH‐OR 0.90 [0.71, 1.13] or erysipela (MH‐OR 0.89 [0.45, 1.77]). The number of events was small, leading to a wide confidence interval that does not allow ruling out an increase in FG or skin and subcutaneous tissue infections.
“…The US FDA recently issued a warning about patients taking sodium-glucose cotransporter-2 (SGLT2) inhibitors in that these patients are liable to develop Fournier's gangrene. This complication usually occurs a few months after starting the medication [1][2][3][4][5][6][7][8][9][10][11][12]. A total of 12 cases have been reported in the literature from May 2013 to May 2018 (Abstract: Chi WC, Lim-Tio S. Fournier's Syndrome: A Life-Threatening Complication of SGLT2 Inhibition in Poorly Controlled Diabetes Mellitus.…”
Fournier's gangrene is an extremely rare infection that can occur in immunocompromised patients, especially those with diabetes. Given the severity of this infection and the new associated link to sodium-glucose cotransporter-2 inhibitors, the US FDA recently issued a warning in August 2018. Few cases of Fournier's gangrene have been reported in the literature in diabetic patients taking these oral medications. We report a case of Fournier's gangrene presenting 10 days after a patient with type 2 diabetes started empagliflozin therapy.
“…The present issue of the Journal of Diabetes includes a case report of a patient with diabetes receiving dapagliflozin who developed necrotizing fasciitis of the scrotal and inguinal regions . On 29 August 2018 the US Food and Drug Administration (FDA) issued a warning that stated: …cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium–glucose cotransporter‐2 inhibitors (SGLT2i) …”
mentioning
confidence: 99%
“…The present issue of the Journal of Diabetes includes a case report of a patient with diabetes receiving dapagliflozin who developed necrotizing fasciitis of the scrotal and inguinal regions. 1 On 29 August 2018 the US Food and Drug Administration (FDA) issued a warning that stated:…”
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