W&L Fights On As Canada Strengthens Warnings Linking Invokana and Farxiga with Kidney InjuriesOctober 27th, 2015
The Canadian counterpart to the U.S. Food and Drug Administration (FDA) this month reported it found sufficient evidence in a safety review to link the SGLT2 inhibitor drugs Invokana and Forxiga (known as Forxiga in the United States) to a risk of acute kidney injury.
The finding by Health Canada was announced as Weitz & Luxenberg’s investigation of cases involving those taking SGLT2 inhibitors who have been hospitalized or deceased continued making headway.
SGLT2 stands for sodium glucose co-transporter 2. SGLT2 inhibitors are a class of drugs indicated for treatment of adult type 2 diabetes mellitus along with diet and exercise.
W&L represents numerous clients (who were prescribed an SLGT2 inhibitor and then were hospitalized with a severe diabetic ketoacidosis (DKA), with some clients also suffering cardiac complications, kidney failure, and coma.
The SLGT2 inhibitors include medications sold under the brand names Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin and metformin extended release), Glyxambi (empagliflozin and linagliptin), and Jardiance (empagliflozin).
SGLT2 Inhibitor Risks Cited
Health Canada’s investigation of acute kidney injury among those taking Invokana and Forxiga arose after the agency learned of serious reports both domestically and internationally.
The agency said in its Oct. 16, 2015 announcement that it is working with Invokana and Forxiga’s manufacturers to strengthen the labeling of those products regarding risk of acute kidney injury.
Health Canada said the two drugs’ labels at the time the agency reviewed them contained only limited warnings about the risks of kidney problems from SGLT2 inhibitors.
At that time the labels contained warnings directed only to patients who already have severe kidney problems or else are receiving dialysis treatments, the agency said.
This safety review regarding acute kidney injury comes several months after the U.S. Food and Drug Administration (FDA), Health Canada, and the European Medicines Agency (EMA) recently notified the public regarding reports of SGLT2 inhibitors and diabetic ketoacidosis, a potentially deadly condition.
W&L Can Help
Health Canada noted that Invokana has been available in Canada since mid-2014. Forxiga, meanwhile, has been on the Canadian market since the beginning of this year.
The agency pointed out that both Invokana and Forxiga, since their respective debuts, have been making strong inroads into the Canadian market.
Health Canada investigated only Invokana and Forxiga, choosing to exclude Jardiance. This exclusion is due to the fact that Jardiance is too new to the Canadian market – its Canadian approval came only two months ago.
Anyone who has taken and been harmed by an SGLT2 inhibitor drug for treatment of adult type 2 diabetes mellitus should contact W&L to explore the potential for receiving injury compensation.
Complete the adjacent form on this page or call W&L toll-free at (855) 274-5624 to arrange for a no-cost, no-obligation consultation with an attorney.