SGLT2 Inhibitor Forxiga Safety Review Launched

Ottawa, Canada: Further to the US Food & Drug Administration' (FDA) warning regarding Invokana, a sodium-glucose cotransporter-2 (SGLT2 ) inhibitors, Health Canada has initiated a safety review for the prescription diabetes drug dapagliflozin (Forxiga) and the risk of ketoacidosis, a serious condition that leads to high levels of blood acids called ketones.

Dapagliflozin is 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' 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.

The FDA is investigating this safety issue and will determine whether changes are needed in the prescribing information for SGLT2 inhibitors. The FDA is warning patients to pay close attention for any signs of ketoacidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.

SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. These medicines are available as single-ingredient products and also in combination with other diabetes medicines such as metformin. The safety and efficacy of SGLT2 inhibitors have not been established in patients with type 1 diabetes, and FDA has not approved them for use in these patients.

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Last updated on Jun-22-15