Recommendations on minimizing risk of diabetic ketoacidosis with SGLT2 inhibitors from PRAC

12 February 2016

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has finalized a review of SGLT2 inhibitors (a class of type 2 diabetes medicines) and has made recommendations to minimize the risk of diabetic ketoacidosis.

Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels. Rare cases of this condition, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors for type 2 diabetes and a number of these cases have been atypical, with patients not having blood sugar levels as high as expected.

An atypical presentation of diabetic ketoacidosis can delay diagnosis and treatment. Healthcare professionals should therefore consider the possibility of ketoacidosis in patients taking SGLT2 inhibitors who have symptoms consistent with the condition even if blood sugar levels are not high.

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