EMA started review of diabetes medicines called SGLT2 inhibitors


The European Medicines Agency (EMA) has started a review of canaglifozin, 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, a serious condition that usually develops in people with type 1 diabetes when insulin levels are too low.

The review of SGLT2 inhibitors has been requested by the European Commission following reports of diabetic ketoacidosis in patients on SGLT2 inhibitor treatment for type 2 diabetes. All cases were serious and some required hospitalisation. Although diabetic ketoacidosis is usually accompanied by high blood sugar levels, in a number of these reports blood sugar levels were only moderately increased. These uncharacteristic blood levels could delay diagnosis and treatment. EMA will now review all available data on the risk of diabetic ketoacidosis with SGLT2 inhibitors and consider any changes are needed in the way these medicines are used in the EU.

While the review is ongoing, healthcare professionals will be informed in writing of the risk of diabetic ketoacidosis and how to manage it. Patients who have any concerns about their diabetes medicines should consult their doctor or pharmacist. It is important that patients with diabetes continue to take their prescribed treatment and do not stop treatment without first discussing with a doctor.

More information on this procedure is accessible on the EMA webpages, or here.