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

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.

Advice for healthcare professionals:

  • carefully monitor patients receiving canagliflozin who have risk factors for amputation, such as poor control of diabetes and problems with the heart and blood vessels
  • consider stopping canagliflozin if patients develop foot complications such as infection, skin ulcers, osteomyelitis, or gangrene
  • advise patients receiving any sodium-glucose co-transporter 2 (SGLT2) inhibitor about the importance of routine preventive foot care and adequate hydration
  • continue to follow standard treatment guidelines for routine preventive foot care for people with diabetes
  • report any suspected side effect with SGLT2 inhibitors or any other medicine on a Yellow Card