Product News and Recalls

Health Canada Launches Safety Review of SGLT2 Inhibitors

Health Canada, the Canadian government’s public health department, has initiated a safety review of the diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors and their link to ketoacidosis. Ketoacidosis is a serious blood condition wherein the body produces excess blood acids, or ketones. Ketoacidosis may require hospitalization and in extreme cases can cause death.

Last month, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication warning of a link between the SGLT2 inhibitors canagliflozin, dapagliflozin, and empagliflozin, and ketoacidosis. A search of the agency’s Adverse Event Reporting System 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.” All 20 cases required treatment by hospitalization or visit to the emergency room.

According to a WFLA news report, a search of Health Canada’s adverse event database turned up a report about a 56-year-old who was hospitalized with diabetic ketoacidosis after taking an SGLT2 inhibitor. The patient in question was taking other drugs at the time of his diagnosis, so like the FDA, Canada Health is unsure of the precise association between SGLT2 inhibitors and ketoacidosis. To this end, they have launched an investigation into the link between canagliflozin and dapagliflozin and heightened blood acid levels.

Symptoms of ketoacidosis include difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Both Canada Health and the FDA are advising patients using SGLT2 inhibitors to seek immediate medical attention should they notice any of these onset signs.

Consult your health care provider before starting or suspending medications. If you or someone close was diagnosed with ketoacidosis after taking an SGLT2 inhibitor, contact Lopez McHugh today to discuss your case free of charge with a seasoned SGLT2 lawyer. You may be eligible to receive compensation for your injuries through an SGLT2 inhibitor lawsuit.