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.

More about this procedure is available on the HALMED webpages, or here. Further information on the PRAC June 2015 meeting is available here.