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SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis. Healthcare professionals should be aware of atypical cases
Notice type:
3rd Party Publications
Date:
12/02/2016
Product name or type:
SGLT2 inhibitors (canagliflozin, dapagliflozin and empagliflozin)
Problem Or Issue:
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has finalised a review of SGLT2 inhibitors (a class of type 2 diabetes medicines) and has made recommendations to minimise 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.
The PRAC's recommendations will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) for the adoption of EMA's final opinion. HPRA will be contacting Healthcare Professionals in due course.
Background Information Or Related Documents:
PRAC recommendation for SGLT2 inhibitors can be seen
here
Further Information:
For full EMA statement please see
here
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Date Printed: 24/04/2024