The European Medicines Agency (EMA) has begun a review into the sodium–glucose cotransporter 2 inhibitor class of antidiabetes drugs, including canagliflozin, dapagliflozin and empagliflozin, following reports of diabetic ketoacidosis (DKA) developing in people with type 2 diabetes who were receiving this treatment.
A total of 101 cases of DKA have been reported worldwide, out of an estimated exposure of more than 500 000 patient-years. All cases were serious and required hospitalisation, and some occurred in people with only mildly elevated blood glucose levels. These uncharacteristic glucose levels, combined with the fact that most DKA cases are observed in people with type 1 diabetes, mean that the diagnosis and treatment of DKA could be delayed.
The EMA will now review all available data on the risk of DKA associated 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 this risk and how to manage it. Patients who have any concerns about their diabetes medicines should consult their doctor or pharmacist. It is important that people with diabetes continue to take their prescribed treatment and do not stop treatment without first discussing with a healthcare professional.
The EMA announcement can be read in full here.
