MHRA drug safety update: risk of Fournier’s gangrene with SGLT2 inhibitors for diabetes

2019 ◽  
Vol 57 (8) ◽  
pp. 117-117 ◽  
2021 ◽  
Author(s):  
Bao Anh Tran ◽  
Wendy H. Updike ◽  
Krystal Bullers ◽  
Erini Serag-Bolos

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.


2021 ◽  
Vol 8 ◽  
Author(s):  
Luke Taylor ◽  
Omar Asmar ◽  
Anirban Mandal ◽  
Ascanio Tridente ◽  
Kevin Hardy ◽  
...  

Introduction: The recent report issued by the MHRA indicating an association of Sodium glucose linked transporter type 2 (SGLT2) Inhibitors with the contraction of Fournier's Gangrene (FG), has been drawn with insufficient supporting evidence and without an adequately powered study to make any meaningful assertions or recommendations. We aimed to look specifically at the currently available dataset used to link SGLT2 Inhibitors to FG and highlight what conclusions or inferences can meaningfully be made, in particular the power of any study that would be required to make sensible conclusions.Methods: World literature review of SGLT2 Inhibitors and FG was performed. With a subsequent 10-year review of cases of FG seen in a regional burns and plastics centre. Data was collected retrospectively from the coding department at Whiston Hospital for all patients with necrotising fasciitis. An electronic document management system was used to identify patients with FG specifically as well as their diabetes state and medication history.Results: Seventy-eight patients were admitted with FG, of whom 32 had diabetes mellitus (DM). Of those with DM none was taking an SGLT2 Inhibitor, 17 patients were taking metformin, a further nine patients were taking a second line medication and 14 required insulin injections.Discussions: DM is a known major risk factor for FG, which is clearly observed in our patient cohort. The risk of patients with DM developing FG is irrespective of the medication patients are taking. The current articles and reports published have little ground to claim an association between SGLT2 Inhibitors and FG and are missing the crucial message that needs to be conveyed to the public: that DM is a major risk factor for FG and patients suffering with diabetes need to be extra vigilant.


2020 ◽  
Vol 11 (3) ◽  
pp. 711-723 ◽  
Author(s):  
Tongtong Wang ◽  
Shrita M. Patel ◽  
Anne Hickman ◽  
Xinyue Liu ◽  
Philip LStJ Jones ◽  
...  

2021 ◽  
Author(s):  
Bao Anh Tran ◽  
Wendy H. Updike ◽  
Krystal Bullers ◽  
Erini Serag-Bolos

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.


2020 ◽  
Vol 67 (6) ◽  
pp. 423-425
Author(s):  
Alejandra García-García ◽  
Francisco Galeano-Valle ◽  
Jose Antonio Nuevo-González ◽  
Pablo Demelo-Rodríguez

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
George Alexiades Stamatiades ◽  
Kinjal Kasbawala ◽  
Aristea Sideri Gugger ◽  
Mehreen Elahee ◽  
Sachin K Majumdar

Abstract Introduction Sodium glucose co-transporter 2 (SGLT2) inhibitors have become an appealing treatment for diabetes due to their favorable cardiac and renal outcomes. However, reports continue to emerge describing potentially life-threatening adverse events such as Fournier’s gangrene (FG) and diabetic ketoacidosis (DKA) associated with their use. Herein, we report a case of simultaneous FG and DKA in a patient taking canagliflozin. Case Presentation A 37-year-old woman with a history of type 2 diabetes mellitus, peripheral neuropathy, and morbid obesity (BMI of 45.8 kg/m2) presented to the hospital with left gluteal pain associated with dysuria despite 5-day treatment with trimethoprim/sulfamethoxazole for a presumed urinary tract infection. Approximately 1 month prior, sitagliptin and canagliflozin were added to her regimen due to poor glycemic control on metformin (HbA1c 9.8%). On examination her temperature was 36.9oC, pulse 117 beats/minute, blood pressure 144/79 mmHg and respiratory rate was 19 bpm. She appeared lethargic and had suprapubic tenderness and induration in the left gluteal region extending to the perineum. Laboratory findings revealed an arterial pH of 7.23 and PCO2 of 34 mmHg, a blood glucose of 402 mg/dL, serum bicarbonate 12mmol/L (20-30mmol/L), an elevated anion gap of 24mmol/L (7-17mmol/L) and a lactate of 1.8 mmol/L. Urinalysis showed 4+ glucose and 1+ ketones. Serum β-hydroxybutyrate was 2.49 mmol/L (0.02-0.27mmol/L). A CT scan of the abdomen and pelvis showed marked inflammatory changes with subcutaneous edema and air within the medial left gluteal soft tissues and locules of air extending into the presacral soft tissues suggestive of Fournier’s gangrene. The diagnoses of Fournier’s gangrene and DKA were made. The patient was started on empirical antibiotic treatment and required six surgical explorations with debridement. Interestingly, initial DKA management included only subcutaneous insulin. Only when serum ketones were identified and the anion gap persisted, insulin infusion with aggressive fluid resuscitation was initiated with successful resolution of anion gap metabolic acidosis. She was discharged with a urinary catheter, vacuum dressing, colostomy with instructions to start insulin glargine 18U and discontinue the oral anti-diabetic medications. Discussion To the best of our knowledge, this is the first case describing the simultaneous occurrence of two potentially fatal adverse effects of SGLT2 inhibitor therapy; Fournier’s gangrene and DKA. In light of the FDA’s warnings and the growing popularity of SGLT2 inhibitor therapy it is important to be mindful of their more serious and potentially fatal complications. It is also important to promptly terminate SGLT2 inhibitors when harmful adverse effects are suspected to prevent further progression.


2021 ◽  
Vol 14 (2) ◽  
pp. e237784
Author(s):  
Ali Elbeddini ◽  
Yasamin Tayefehchamani ◽  
Michelle Davey ◽  
Jodi Gallinger ◽  
Naushin Hooda ◽  
...  

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.


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