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Dear Doctor Letter (Rote-Hand-Brief) on Sodium-Glucose-Co-Transporter 2 inhibitors (SGLT2i): risk of Fournier´s gangrene (necrotising fasciitis of the perineum)

Active substance: SGLT2 inhibitors

The Marketing Authorisation Holders (MAH) of products containing SGLT2 inhibitors [Invokana (canagliflozin), Forxiga (dapagliflozin), Jardiance (empagliflozin), Steglatro (ertugliflozin)], in agreement with the European Medicines Agency (EMA) and the Federal Institute for Medicinal Products and Medical Devices (BfArM), would like to inform you that post-marketing cases of Fournier´s gangrene (necrotising fasciitis of the perineum) have been associated with the use of SGLT2 inhibitors.

Fournier´s gangrene is a rare but serious and potentially life-threatening infection. Uro-genital infection or perineal abscess may precede necrotizing fasciitis. Patients should be advised to seek urgent medical attention if they experience severe pain, tenderness, erythema, or swelling in the genital or perineal area accompanied by fever or malaise. If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and promptly start treatment (including antibiotics and surgical debridement).

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 965KB, File is accessible

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