SGLT2 inhibitors: risk of diabetic ketoacidosis

Patients receiving SGLT2 inhibitors (canagliflozin, dapagliflozin or empaglifozin) should be monitored for diabetic ketoacidosis, the MHRA has advised.

Prescribers are reminded that SGLT2 inhibitors are not licensed for the treatment of type I diabetes.
Prescribers are reminded that SGLT2 inhibitors are not licensed for the treatment of type I diabetes.

Serious and life-threatening cases of diabetic ketoacidosis have been reported in patients taking SGLT2 inhibitors. In several cases, blood glucose levels were only moderately elevated (eg, <14 mmol/L or 250mg/dL), which is atypical for diabetic ketoacidosis. 

The MHRA has issued the following recommendations for prescribers:

  • Test for raised ketones in patients with symptoms of diabetic ketoacidosis, even if plasma glucose levels are near-normal. 
  • Discontinue treatment if diabetic ketoacidosis is suspected. 
  • If diabetic ketoacidosis is confirmed, take appropriate corrective measures and monitor glucose levels.
  • Continue to report suspected side-effects of SGLT2 inhibitors.

Further information
MHRA Drug Safety Update 
View SGLT2 inhibitor drug records

To avoid a delay in diagnosis and treatment of diabetic ketoacidosis, prescribers should inform patients of the symptoms and signs:

  • nausea
  • vomiting
  • anorexia
  • abdominal pain
  • excessive thirst
  • difficulty breathing
  • confusion
  • unusual fatigue or sleepiness.
Prescribers are reminded that SGLT2 inhibitors are not approved for the treatment of type I diabetes. 
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