Review of type 2 medicines over diabetic ketoacidosis risk

By Editor
29th July 2015
Latest news, Pharmaceutical

A review has been launched across Europe into the safety of type 2 diabetes medicines known as SGLT2 inhibitors.

The investigation by The European Medicines Agency (EMA) comes at the request of the European Commission following more than 100 cases of diabetic ketoacidosis (DKA) in people treated with canagliflozin, dapagliflozin and empagliflozin.

They had shown symptoms of DKA such as excessive thirst, unusual fatigue, confusion, and high blood glucose levels.

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.

A statement from EMA said: “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.

While the review is ongoing, healthcare professionals will be informed in writing of the risk of diabetic ketoacidosis and how to manage it

“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 whether 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 healthcare professional.”

A total of 101 cases of diabetic ketoacidosis in people treated with SGLT2 inhibitors for type 2 diabetes had been reported worldwide as of May 19, 2015.

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