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Safety Review of SGLT2 Inhibitors Initiated by Health Canada

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Ottawa, CanadaHealth Canada has initiated a safety review for the prescription diabetes drugs Dapagliflozin (Forxiga) and canagliflozin (Invokana), and the risk of ketoacidosis, a serious condition that leads to high levels of blood acids called ketones. These drugs are approved in Canada for use in patients with type 2 diabetes to improve blood sugar levels, along with diet and exercise.

A preliminary search of Health Canada’s adverse reaction database identified one report of diabetic ketoacidosis involving the hospitalization of a 56-year old male taking an SGLT2 inhibitor. The patient was taking other medications at the time and further assessment will be conducted.

In the US, a search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014 (see Data Summary). All patients required emergency room visits or hospitalization to treat the ketoacidosis. Since June 2014, the FDA continues to receive additional FAERS reports for DKA and ketoacidosis in patients treated with SGLT2 inhibitors.

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