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.

Agenda

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

Related content

How useful was this page?

Add your rating