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

News 12/06/2015

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.


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

Start of referral procedure

SGLT2 inhibitors

Article-20 procedure: SGLT2 inhibitors

PDF icon Review started
PDF icon Referral notification
PDF icon PRAC list of questions
PDF icon Timetable for the procedure

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