Side Effects of Invokana, Farxiga Reviewed by Health Canada

Following a warning issued by U.S. regulators last month, and continuing concerns over potential health risks associated with side effects of Invokana, Farxiga (sold as Forxiga in some countries) and other new-generation diabetes drugs, Canadian health officials have announced that they are launching a similar investigation into reports of users hospitalized due to high blood acid levels. 

In a press release issued on June 22, Health Canada indicated that it is reviewing reports of ketoacidosis associated with a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors.

The review comes after a recent FDA warning about the risk of ketacidosis from Invokana and other related diabetes drugs on May 15. The U.S. regulatory agency indicated that at least 20 cases of diabetic ketoacidosis (DKA) were reported during the first 15 months Invokana was on the market, with all of the cases involving hospitalization or emergency room treatment.

The FDA warning was followed by an announcement by the European Medicines Agency (EMA) that it was placing Invokana and similar drugs under closer observation as well.

Health Canada notes that when it looked through its own adverse event database it found only one report of a 56-year-old man being hospitalized for diabetic ketoacidosis after taking a SGLT2 inhibitor. That case is still under assessment, however, as the patient was taking other medications at the time as well.

While the safety review is underway, Health Canada is warning citizens to be aware of the symptoms and risks of ketoacidosis if they are taking an SGLT2 inhibitor class.

Ketoacidosis is a serious and potentially life threatening medical condition that occurs when high levels of blood acids, known as ketones, build up in the blood. This can result in difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, often requiring urgent medical treatment.

Since the FDA statement in May, a number of product liability lawyers have begun investigating potential Invokana lawsuits and Farxiga lawsuits over the drug maker’s failure to adequately warn consumers and the medical community.

As a result of the regulatory reviews by the FDA, Health Canada, and EMA, more stringent warnings may be required for Invokana and other drugs in the same class, such as Farxiga, Glyxambi, Jardiance, and Xigduo XR.