On June 22, 2015, Health Canada announced that it has initiated a safety review of sodium-glucose cotransporter-2 (SGLT2) inhibitors Invokana (canagliflozin) and Forxiga (dapagliflozin), and their risk of causing diabetic acidosis. SGLT2 inhibitors are a new class of drugs used to treat type 2 diabetes. Invokana was approved by the U.S. Food and Drug Administration (FDA) in March, 2013, and was not approved in Canada until May, 2014.
Invokana Linked to Diabetic Ketoacidosis
On May 15, 2015, the FDA issued a safety warning about the risk of ketoacidosis linked to use of SGLT2 inhibitors, including Invokana. The FDA’s warning was based on 20 cases found in the FDA Adverse Event Reporting System (FAERS) database.
Little more than a month later Health Canada, the Canadian equivalent of the FDA, has announced its own safety review of SGLT2 inhibitors and the risk of diabetic ketoacidosis. The agency says that a preliminary search of its adverse reaction database identified one report of diabetic ketoacidosis involving the hospitalization of a patient using an SGLT2 inhibitor.
Diabetic Ketoacidosis in SGLT2 Users
Diabetic ketoacidosis is a dangerous and potentially fatal condition. It is typically seen in people with type 1 diabetes with significantly elevated blood sugar levels. When the condition is seen in Invokana and other SGLT2 inhibitor users, the cases are unusual because the victims have type 2 diabetes and only mildly elevated blood sugar.
Those who have been harmed by Invokana may be able to recover substantial compensation for their injuries.