From the Guidelines
SGLT2 inhibitors, a class of diabetic medications, have been associated with Fournier's gangrene, a rare but serious form of necrotizing fasciitis affecting the genital and perineal regions, as reported in a study published in 2022 1. This class includes medications such as empagliflozin (Jardiance), dapagliflozin (Farxiga), canagliflozin (Invokana), and ertugliflozin (Steglatro). While the absolute risk is low, patients taking these medications should be aware of symptoms like genital or perineal pain, redness, swelling, or fever, and seek immediate medical attention if these develop. The mechanism behind this association likely involves increased urinary glucose excretion, which may promote bacterial growth in the genital region. Patients with diabetes are already at higher risk for infections due to compromised immune function and elevated blood glucose levels. Despite this rare side effect, SGLT2 inhibitors remain valuable medications for managing type 2 diabetes and have demonstrated cardiovascular and renal benefits, as shown in studies such as the DAPA-CKD trial 1 and the EMPEROR trials 1. However, proper hygiene and regular monitoring are essential for patients using these medications, as emphasized in guidelines such as the European Association of Urology guidelines on urological infections 1. Some key points to consider include:
- The importance of prompt recognition and treatment of Fournier's gangrene, as delayed treatment can lead to increased mortality 1.
- The use of scoring systems such as the Laboratory Risk Indicator for Necrotising Fasciitis (LRINEC) score and the Fournier's Gangrene Severity Index (FGSI) to aid in diagnosis and prognosis 1.
- The need for a multidisciplinary approach to management, including surgical debridement, antibiotic therapy, and supportive care 1.
- The potential for SGLT2 inhibitors to increase the risk of genital mycotic infections, and the importance of counseling patients on genital hygiene 1.
From the FDA Drug Label
Necrotizing Fasciitis of the Perineum (Fournier's Gangrene) Reports of necrotizing fasciitis of the perineum (Fournier's gangrene), a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in postmarketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors, including INVOKANA Cases have been reported in both females and males. Inform patients that necrotizing infections of the perineum (Fournier’s Gangrene) have occurred with dapagliflozin in patients with diabetes mellitus Counsel patients to promptly seek medical attention if they develop pain or tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, along with a fever above 100.4°F or malaise
The diabetic medications canagliflozin and dapagliflozin are associated with necrosis of the scrotum, specifically Fournier's gangrene, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention 2 3 3.
From the Research
Diabetic Medications Associated with Fournier's Gangrene
The following diabetic medications have been associated with an increased risk of Fournier's gangrene:
Mechanism of Action
These medications are sodium-glucose cotransporter 2 (SGLT2) inhibitors, which increase the risk of genital infections due to their glycosuric effects 4, 5, 6, 8.
Risk Factors
Risk factors for developing Fournier's gangrene while taking SGLT2 inhibitors include:
- Diabetes 4, 5, 6, 8
- Obesity 4
- Immunocompromised states 4, 8
- Smoking 4
- Alcohol abuse 4
- End-stage renal or liver failure 4
- Age 5, 8
- Gender (male) 5, 8
Treatment and Management
Treatment for Fournier's gangrene typically involves emergency surgical debridement, broad-spectrum antibiotics, and discontinuation of the SGLT2 inhibitor 4, 5, 6, 7.