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

2021 ◽  
pp. cd210015
Author(s):  
Bao Anh Tran ◽  
Wendy H. Updike ◽  
Krystal Bullers ◽  
Erini Serag-Bolos
Keyword(s):  
Case Reports ◽  
Fournier’S Gangrene ◽  
Fournier's Gangrene ◽  
Sodium Glucose Cotransporter ◽  
Post Marketing

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.

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.

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.

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

scholarly journals Undiagnosed Behçet’s Disease Presenting as Fournier’s Gangrene in a Young Male

2021 ◽  
Vol 2021 ◽  
pp. 1-2
Author(s):  
Jasmine C. Winyard ◽  
Anton Wong ◽  
Hala Rashed ◽  
John K. Mellon
Keyword(s):  
Risk Factors ◽  
Behçet’S Disease ◽  
Behcet’S Disease ◽  
Behçet's Disease ◽  
Case Reports ◽  
Young Male ◽  
Paediatric Population ◽  
Fournier’S Gangrene ◽  
Fournier's Gangrene ◽  
Behcet's Disease

Behçet’s disease is rare, especially in the paediatric population. In this case, a healthy 16-year-old made presented with discrete scrotal ulcers and systemic illness. He was found to have Fournier’s gangrene and with subsequent investigation was diagnosed with Behçet’s disease as an underlying cause. A PubMed search reveals no similar case reports. His only risk factors for Fournier’s gangrene was his raised body mass index. His only risk factor for Behçet’s disease was his ethnic origin. An understanding of risk factors and epidemiology can raise suspicion of these rare pathologies.

scholarly journals Localized Fournier’s Gangrene in “End-Stage” Renal Failure: Multidisciplinary Approach and Integration of Palliative Care

2020 ◽  
Vol 2020 ◽  
pp. 1-5
Author(s):  
M. Voordeckers ◽  
J. Noels ◽  
M. Brognet ◽  
M. T. Salaouatchi ◽  
M. Mesquita
Keyword(s):  
Palliative Care ◽  
End Of Life ◽  
End Of Life Care ◽  
Case Reports ◽  
Vascular Complications ◽  
Fournier’S Gangrene ◽  
Morbidity And Mortality ◽  
Time Interval ◽  
Life Care ◽  
Fournier's Gangrene

Presentation of the Case. Penile gangrene is a rare entity with significant morbidity and mortality. There are only few case reports of isolated penile Fournier’s gangrene in literature. Its rare occurrence, associated with complex and serious comorbidity, poses a major challenge to the attending medical personnel. A 53-year-old Caucasian patient with poorly controlled diabetes, progressive renal insufficiency, and multiple vascular complications presented with progressive necrosis of the penis (localized Fournier’s gangrene). Discussion. Fournier’s gangrene or necrotizing fasciitis refers to any synergistic necrotizing infection of the external genitalia or perineum and is a hallmark of severe systemic vascular disease. Fournier’s gangrene is an absolute emergency because the time interval between diagnosis and treatment significantly influences morbidity and mortality. Despite aggressive management, the estimated mortality rates range from 57 to 71%. Conclusions. Improved integration of palliative care services into the care of such patients is important to improve end-of-life care even though they do not have a malignant disease. The “Palliative Care Indicator Tool” can help identifying people at risk of deteriorating health and is important to improve end-of-life care.

scholarly journals USEFULNESS OF FECAL INCONTINENCE CATHETER (Flexi-Seal®) FOR POSTOPERATIVE MANAGEMENT OF EVACUATION IN FOURNIER'S GANGRENE: TWO CASE REPORTS

2016 ◽  
Vol 107 (1) ◽  
pp. 59-62
Author(s):  
Yushi Yamauchi ◽  
Shinri Yoshida ◽  
Ryo Ishida ◽  
Toshinori Nishikimi ◽  
Hiroshi Yamada ◽  
...  
Keyword(s):  
Fecal Incontinence ◽  
Case Reports ◽  
Postoperative Management ◽  
Fournier’S Gangrene ◽  
Fournier's Gangrene

scholarly journals The risk for urinary tract infections with sodium-glucose cotransporter 2 inhibitors: no longer a cause of concern?

2019 ◽  
Vol 13 (1) ◽  
pp. 24-26 ◽  
Author(s):  
Pantelis A Sarafidis ◽  
Alberto Ortiz
Keyword(s):  
Type 2 Diabetes ◽  
Urinary Tract ◽  
Case Reports ◽  
European Medicines Agency ◽  
Sodium Glucose Cotransporter ◽  
Increased Risk ◽  
The Us ◽  
Post Marketing ◽  
Tract Infections

Abstract Sodium–glucose co-transporter-2 (SGLT2) inhibitors improve cardiovascular and renal outcomes in patients with type 2 diabetes, including those with diabetic kidney disease. However, the US Food and Drug Administration and European Medicines Agency warnings about potential adverse effects, such as urosepsis and pyelonephritis, based on post-marketing case reports, may deter physicians from prescribing these drugs. A recent evaluation of two large US-based databases of commercial claims failed to find evidence for an increased risk of urinary tract infection (UTI) or severe UTI in type 2 diabetes patients who were prescribed an SGLT2.

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