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EMA review into SGLT2 inhibitors

11 August 2015

The European Medicines Agency (EMA) have launched a review into the safety of SGLT2 inhibitors. The investigation comes after more than 100 cases of DKA in people treated with canaglifozin, dapagliflozin and empagliflozin. The EMA noted that although DKA is usually accompanied by high blood glucose levels, in a number of these cases blood glucose levels were only moderately increased. These uncharacteristic blood glucose levels could delay diagnosis and therefore treatment of DKA. The review will look at all available data on the risk of DKA with SGLT2 inhibitors and will consider if any changes are needed to how they are used in the EU.  Healthcare professionals will be written to regarding the risk of DKA and how to manage it. 

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