SGLT2 inhibitors: advice on the risk of diabetic ketoacidosis (MHRA release April 2016)

Test for raised ketones in patients with ketoacidosis symptoms, even if plasma glucose levels are near-normal.

Further information can be found in the MHRA Drug Safety Update


SGLT2 inhibitors: advice on increased risk of lower-limb amputation (mainly toes) (MHRA release March 2017)

Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes. Evidence does not show an increased risk for dapagliflozin and empagliflozin, but the risk may be a class effect. Preventive foot care is important for all patients with diabetes.

Further information can be found in the MHRA Drug Safety Update


SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) (MHRA release February 2019)

If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and start treatment urgently (including antibiotics and surgical debridement). Fournier’s gangrene is a rare but potentially life-threatening infection that requires urgent medical attention.

Further information can be found in the MHRA Drug Safety Update


SGLT2 inhibitors: monitor ketones in blood during treatment interruption for surgical procedures or acute serious medical illness (MHRA release March 2020)


SGLT2 inhibitor treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses and ketone levels measured, preferably in blood rather than urine. Treatment may be restarted when the ketone values are normal and the patient's condition has stabilised.

Further information can be found in the MHRA Drug Safety Update