The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a safety alert following report of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) with sodium-glucose co-transporter 2 (SGLT2) inhibitors.
In November 2018, a European Union (EU) review assessed the reported cases of Fournier’s gangrene across the class of SGLT2 inhibitors. Although diabetes mellitus is a risk factor for the development of Fournier’s gangrene, some of the EU post-marketing reports were considered possibly to be related to the use of SGLT2 inhibitors. While Fournier’s gangrene usually occurs almost exclusively in men, around a third of the EU cases reviewed were reported in women. Cases have also been reported in the United States.
In the United Kingdom, 6 cases (4 in men and 2 in women) have been reported in association with SGLT2 inhibitors up to January 2019, corresponding to a UK estimated exposure to SGLT2 inhibitors of 548,565 patient-years of treatment.
Prescribers are advised to stop SGLT2 inhibitor therapy and urgently start treatment (including antibiotics and surgical debridement as required) if Fournier’s gangrene is suspected. The MHRA is also advising prescribers to instruct patients receiving SGLT2 inhibitors 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.
SGLT2 inhibitors authorised in the United Kingdom include Edistride (dapagliflozin), Forxiga (dapagliflozin), Ebymect (dapagliflozin/metformin), Xigduo (dapagliflozin/metformin), Qtern (dapagliflozin/saxagliptin), Invokana (canagliflozin), Vokanamet (canagliflozin/metformin), Jardiance (empagliflozin), Synjardy (empagliflozin/metformin), Glyxambi (empagliflozin/linagliptin), Steglatro (ertugliflozin), Segluromet (ertugliflozin/metformin) and Steglujan (ertugliflozin/sitagliptin).
