PRAC News – June 2015
The PRAC has started a review of medicines for diabetes from the group of SGLT2 inhibitors due to a risk of diabetic ketoacidosis.
The European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review of the following medicines from the SGLT2: kanagliflozin, dapagliflozin and empagliflozin. The aim of this procedure is to assess the risk of diabetic ketoacidosis associated with use of these medicines. The diabetic ketoacidosis is a serious condition occurring in general in type 1 diabetic patients when the insulin level is to low.