Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2015

12 June 2015

Review of diabetes medicines called SGLT2 inhibitors

The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of canagliflozin, dapagliflozin and empagliflozin, which are medicines known as SGLT2 inhibitors used to treat type 2 diabetes. The aim of the review is to evaluate the risk of diabetic ketoacidosis with these medicines. Diabetic ketoacidosis is a serious condition that usually develops in people with type 1 diabetes when insulin levels are too low.

More information is included in the table below.

Agenda

Agenda - PRAC draft agenda of meeting 8-11 June 2015

Start of referral procedure

SGLT2 inhibitors
Article-20 procedure: SGLT2 inhibitors SGLT2 inhibitors Article-20 procedure - Review started SGLT2 inhibitors Article-20 procedure - Notification SGLT2 inhibitors Article-20 procedure - PRAC list of questions SGLT2 inhibitors Article-20 procedure - Timetable for the procedure