scholarly journals Sodium–Glucose Cotransporter 2 Inhibitor Use Associated With Fournier's Gangrene: A Review of Case Reports and Spontaneous Post-Marketing Cases

2021 ◽  
Author(s):  
Bao Anh Tran ◽  
Wendy H. Updike ◽  
Krystal Bullers ◽  
Erini Serag-Bolos
Keyword(s):  
Mortality Rate ◽  
Case Reports ◽  
Fournier’S Gangrene ◽  
Boxed Warning ◽  
Sglt2 Inhibitors ◽  
Fournier's Gangrene ◽  
Sodium Glucose Cotransporter ◽  
Potential Development ◽  
Post Marketing ◽  
The U.S

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.

scholarly journals Sodium–Glucose Cotransporter 2 Inhibitor Use Associated With Fournier's Gangrene: A Review of Case Reports and Spontaneous Post-Marketing Cases

2021 ◽  
Author(s):  
Bao Anh Tran ◽  
Wendy H. Updike ◽  
Krystal Bullers ◽  
Erini Serag-Bolos
Keyword(s):  
Mortality Rate ◽  
Case Reports ◽  
Fournier’S Gangrene ◽  
Boxed Warning ◽  
Sglt2 Inhibitors ◽  
Fournier's Gangrene ◽  
Sodium Glucose Cotransporter ◽  
Potential Development ◽  
Post Marketing ◽  
The U.S

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.

scholarly journals Fournier’s gangrene with dapagliflozin in a rural hospital: a case report

2021 ◽  
Vol 14 (2) ◽  
pp. e237784
Author(s):  
Ali Elbeddini ◽  
Yasamin Tayefehchamani ◽  
Michelle Davey ◽  
Jodi Gallinger ◽  
Naushin Hooda ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Wound Care ◽  
Case Reports ◽  
Signs And Symptoms ◽  
Fournier’S Gangrene ◽  
Sglt2 Inhibitors ◽  
Fournier's Gangrene ◽  
Urogenital Infections ◽  
Anogenital Area

Sodium-glucose cotransporter 2 (SGLT2) inhibitors, which are used for treatment of type 2 diabetes, are associated with risk of urogenital infections. FDA issued a black box warning about multiple case reports of Fournier’s gangrene (FG) observed in patients taking SGLT2 inhibitors. FG is a type of necrotising fasciitis that occurs in the anogenital area. We report a case of a 71-year-old woman with type 2 diabetes on dapagliflozin, presenting with foul-smelling discharge and a large abscess in the perianal area. Her risk factors for FG included her advanced age, obesity, diabetes and trauma to the site. During her stay, dapagliflozin was discontinued and she received procedural debridement, wound care and broad-spectrum intravenous antibiotics. Due to possible association between FG and SGLT2 inhibitors, patients presenting with signs and symptoms of FG who are taking SGLT2 inhibitors should be examined for infection in the urogenital area and treated promptly.

Fournier's gangrene as Amyand's hernia complication

2019 ◽  
Vol 98 (7) ◽  
pp. 291-296
Keyword(s):  
Case Report ◽  
Case Reports ◽  
Rare Condition ◽  
Sporadic Case ◽  
Fournier’S Gangrene ◽  
Amyand’S Hernia ◽  
Fournier's Gangrene ◽  
Randomized Controlled Studies ◽  
Based Medicine ◽  
Hernia Complication

Introduction: Fournier’s gangrene is a rare but fast deteriorating and serious condition with high mortality. In most cases, it is characterized as necrotizing fasciitis of the perineum and external genitals. Amyand’s hernia is a rare condition where the appendix is contained in the sac of an inguinal hernia. Inflammatory alterations in the appendix account only for 0.1 % of the cases when Amyand’s hernia is verified. Fournier’s gangrene as a complication of a late diagnosis of appendicitis located in the inguinal canal is described in the literature as rare case reports. Case report: The case report of a 70-year-old patient with Fournier’s gangrene resulting from gangrenous appendicitis of Amyand’s hernia. Conclusion: Fournier’s gangrene as a complication of Amyand’s hernia is a rare condition. Only sporadic case reports thereof can be found in the literature. Because of the rarity of this pathology and the lack of randomized controlled studies, it is difficult to determine the optimal treatment according to the principles of evidence-based medicine. An appropriate approach for this condition appears to be the combination of guidelines developed in Amyand’s therapy according to Losanoff and Basson, along with the recommended “gold standard” therapy for Fournier’s gangrene. This means early and highly radical surgical debridement, adequate antibiotic therapy and intensive care.

Gangrena de Fournier. Reporte de caso

2020 ◽  
Vol 63 (5) ◽  
pp. 26-30
Author(s):  
Paloma Pérez Ladrón de Guevara ◽  
Georgina Cornelio Rodríguez ◽  
Oscar Quiroz Castro
Keyword(s):  
Mortality Rate ◽  
Necrotizing Fasciitis ◽  
Broad Spectrum ◽  
Soft Tissues ◽  
Fournier’S Gangrene ◽  
Type Ii ◽  
Necrotic Tissue ◽  
Fournier's Gangrene ◽  
Necrotizing Fascitis ◽  
Key Words Fournier's Gangrene

Fournier’s Gangrene is a type II necrotizing fascitis that leads to thrombosis of small subcutaneous vessels and spreads through the perianal and genital regions and the skin of the perineal. Most cases have a perianal or colorectal focus and in a smaller proportion it originates from the urogenital tract. The mortality rate varies between 7.8 and 50%1-3, only timely diagnosis decreases the morbidity and mortality of this condition. Treatment includes surgical debridement of all necrotic tissue and the use of broad-spectrum antibiotics. Key words: Fournier’s gangrene; gangrene; necrotizing fasciitis; infectious necrotizing of soft tissues.

scholarly journals Pharmacovigilance assessment of the association between Fournier’s gangrene and other severe genital adverse events with SGLT-2 inhibitors

2019 ◽  
Vol 7 (1) ◽  
pp. e000725 ◽  
Author(s):  
Gian Paolo Fadini ◽  
Mayur Sarangdhar ◽  
Fabrizio De Ponti ◽  
Angelo Avogaro ◽  
Emanuel Raschi
Keyword(s):  
Reporting System ◽  
Immunosuppressive Drugs ◽  
Fournier’S Gangrene ◽  
Rare Occurrence ◽  
Fournier's Gangrene ◽  
Glucose Lowering ◽  
Sodium Glucose Cotransporter ◽  
Definition Of ◽  
Reporting Frequency ◽  
Design And Methods

ObjectiveSodium glucose cotransporter-2 inhibitors (SGLT2i) exert cardiorenal protection in people with diabetes. By inducing glycosuria, SGLT2i predispose to genital infections. In addition, rare occurrence of Fournier’s gangrene (FG) has been reported. We aimed to investigate such association through the U.S. Food and Drug Administration (FDA) adverse event (AE) reporting system (FAERS).Research design and methodsWe mined the FAERS up to 2018q3 (before FDA warning about SGLT2i-associated FG) to retrieve reports including FG as an AE and SGLT2i as suspect or concomitant drugs, and calculated proportional reporting ratios (PRR).ResultsWe retrieved 47 cases of FG and 17 cases of other severe AEs of the genital area associated with SGLT2i. Patients with FG were ~10 years older than those with other severe genital AEs. Overall, 77% occurred in men. Three patients were concomitantly treated with systemic immunosuppressive drugs. Increased reporting frequency emerged for SGLT2i compared with other drugs, with a PRR ranging from 5 to 10. The disproportional reporting of FG with SGLT2i remained robust and consistently significant when restricting to the period when SGLT2i were available, to reports filed for glucose-lowering medications or for drugs with the diabetes indication, and after refining the definition of FG. FG was disproportionally associated with psoriasis and with the combination of immunosuppressants and SGLT2i.ConclusionsAlthough causality cannot be demonstrated, SGLT2i may predispose to FG and other severe genital AEs. Since the use of SGLT2i is expected to increase significantly, clinicians should be aware of these severe, although rare, AEs and their predisposing factors.

MICROBIOLOGICAL PROFILE, ANTIBIOTIC SENSITIVITY AND PROGNOSIS OF PATIENTS WITH FOURNIER’S GANGRENE: A PROSPECTIVE, HOSPITAL BASED STUDY FROM NORTH INDIA

2021 ◽  
pp. 78-80
Author(s):  
Sanjay Gupta ◽  
Ajay Kumar ◽  
Adiveeth Deb
Keyword(s):  
Mortality Rate ◽  
Acinetobacter Baumannii ◽  
Ventilatory Support ◽  
Antibiotic Sensitivity ◽  
Fournier’S Gangrene ◽  
North India ◽  
Klebsiella Pneumonia ◽  
Bacterial Strains ◽  
Perianal Region ◽  
Fournier's Gangrene

Background: Fournier's gangrene (FG) is a devastating disease that is characterized by necrotizing fasciitis of the perineal, genital, or perianal region. Broad-spectrum antibiotics are the key component of its treatment. However, there is paucity of data regarding the optimal empirical antibiotic therapy for FG. Materials and Methods: Data from patients who underwent surgery for FG was retrieved from a prospectively collected departmental FG database. Demographics, clinical characteristics, causative pathogens and drug susceptibility/resistance were evaluated. Outcome was also assessed in terms of mortality. Results: Fifty patients with a median age of 58.5 (40-83) years were included. The perianal region and scrotum (88%) were the most commonly affected. Diabetes mellitus (DM) was the most common comorbidity (92%). The median time to onset of symptoms was 7 (2-15) days, and the median duration of hospital stay was 22 (4-65) days. Ventilator requirement was required in 15 (30%) patients. The median UFGSI score was 9.5 (3-15). The overall mortality rate was 26%. A positive growth was found in specimen cultures of 48 (96%) patients. The median number of bacterial strains that grew in the cultures was 3 (0-10). Amikacin was the antibiotic with the highest frequency of sensitivity (74%), while the highest resistance was observed against ampicillin-sulbactam (64%). Escherichia coli was the most common microorganism (68%). Acinetobacter baumannii and Klebsiella pneumonia were signicantly more common in patients who required mechanical ventilation. The mortality rate was 26%. An Uludag Fournier's Gangrene Severity Index (UFGSI) score of > 9.5 and ventilatory support requirement were factors associated with an increased rate of mortality. Acinetobacter baumannii was the only microorganism which was associated with an increased mortality rate. Conclusion: Causative pathogens in FG appeared to be shifting; thus, empirical antibiotic treatment for this disease should be modied. We recommend 3rd-generation cephalosporin, metronidazole and amikacin for empirical therapy.

scholarly journals Real-world evidence on sodium-glucose cotransporter-2 inhibitor use and risk of Fournier’s gangrene

2020 ◽  
Vol 8 (1) ◽  
pp. e000985 ◽  
Author(s):  
Jeff Yufeng Yang ◽  
Tiansheng Wang ◽  
Virginia Pate ◽  
John B Buse ◽  
Til Stürmer
Keyword(s):  
Real World ◽  
Fournier’S Gangrene ◽  
Sensitivity Analyses ◽  
Standardized Mortality Ratio ◽  
Fournier's Gangrene ◽  
Diagnosis Codes ◽  
Sodium Glucose Cotransporter ◽  
Real World Evidence ◽  
Increased Risk ◽  
The Impact

BackgroundSodium-glucose cotransporter-2 inhibitors (SGLT2i) have been associated with increased occurrence of Fournier’s gangrene (FG), a rare but serious form of necrotizing fasciitis, leading to a warning from the Food and Drug Administration. Real-world evidence on FG is needed to validate this warning.MethodsWe used data from IBM MarketScan (2013–2017) to compare the incidence of FG among adult patients who initiated either SGLT2i, a dipeptidyl peptidase-4 inhibitor (DPP4i), or any non-SGLT2i antihyperglycemic medication. FG was defined using inpatient International Classification of Diseases, Ninth Edition and Tenth Edition diagnosis codes 608.83 and N49.3, respectively, combined with procedure codes for debridement, surgery, or systemic antibiotics. We estimated crude incidence rates (IRs) using Poisson regression, and crude and adjusted HRs (aHR) and 95% CIs using standardized mortality ratio-weighted Cox proportional hazards models. Sensitivity analyses examined the impact of alternative outcome definitions.ResultsWe identified 211 671 initiators of SGLT2i (n=93 197) and DPP4i (n=118 474), and 305 329 initiators of SGLT2i (n=32 868) and non-SGLT2i (n=272 461). Crude FG IR ranged from 3.2 to 3.8 cases per 100 000 person-years during a median follow-up of 0.51–0.58 years. Compared with DPP4i, SGLT2i initiation was not associated with increased risk of FG for any outcome definition, with aHR estimates ranging from 0.25 (0.04–1.74) to 1.14 (0.86–1.51). In the non-SGLT2i comparison, we observed an increased risk of FG for SGLT2i initiators when using FG diagnosis codes alone, using all diagnosis settings (aHR 1.80; 0.53–6.11) and inpatient diagnoses only (aHR 4.58; 0.99–21.21).ConclusionsNo evidence of increased risk of FG associated with SGLT2i was observed compared with DPP4i, arguably the most relevant clinical comparison. However, uncertainty remains based on potentially higher risk in the broader comparison with all non-SGLT2i antihyperglycemic agents and the rarity of FG.Trial registration numberEUPAS Register Number 30018.

scholarly journals Fournier's gangrene and sodium–glucose cotransporter 2 inhibitors: Is there a causal association?

2019 ◽  
Vol 11 (5) ◽  
pp. 340-341 ◽  
Author(s):  
Zachary Bloomgarden ◽  
Daniel Einhorn ◽  
George Grunberger ◽  
Yehuda Handelsman
Keyword(s):  
Fournier’S Gangrene ◽  
Causal Association ◽  
Fournier's Gangrene ◽  
Sodium Glucose Cotransporter

Fournier's gangrene: Report on two cases

1997 ◽  
Vol 64 (2) ◽  
pp. 266-268
Author(s):  
F. Laganà ◽  
E. Cossaro ◽  
C. Ronconi ◽  
F. Sercia ◽  
M. Marchini
Keyword(s):  
Mortality Rate ◽  
Chronic Diseases ◽  
High Mortality ◽  
Hyperbaric Oxygenation ◽  
Fournier’S Gangrene ◽  
Fournier's Gangrene ◽  
Tissue Ischemia ◽  
First Choice

– Fournier's gangrene is a rare pathology that generally occurs in weakened patients with chronic diseases, like diabetes, which imply tissue ischemia and even today a high mortality rate. Two cases are presented, one of which is interesting for its pathogenesis. The authors confirm that first choice treatment should be surgical associated with antiobiotics and hyperbaric oxygenation whenever possible.

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