Health Canada Revises Safety Warning on Invokana

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Health Canada proposed a safety warning on May 2016, before the warning the safety review was launched in June of last year and its conclude Invokana and the other prescription diabetes drugs like dapagliflozin (Forxiga) are linked with severe life threatening side effects. As per the Health Canada reports this class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors are associated with the risk of ketoacidosis, a serious condition that leads to high levels of blood acids called ketones. Health Canada’s safety review found that the use of Invokana and Forxiga increase the risk of acute kidney injury. According to the safety review this drugs medication lead to serious adverse event includes acute kidney injury, acute renal failure and severe renal impairment. These kidney issues occur when the kidneys suddenly become unable to filter waste products from the blood. As per the review Invokana and Forxiga, marketed since June 2014 and January 2015, subsequently. Invokana and Forxiga use has been steadily increasing since the time of their marketing in Canada.

Invokana and its adverse reactions

Invokana (canagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor used to control blood sugar in people with type 2 diabetes mellitus, along with diet and exercise. This drug lead to Ketoacidosis, is a very dangerous and potentially life-threatening medical condition that needs to be diagnosed and treated as soon as possible as it can cause diabetic coma or even death due to the bloodstream becoming overwhelmed with toxic acid. Ketoacidosis is most common in untreated type 1 diabetes mellitus, when the liver breaks down fat and proteins in response to a perceived need for respiratory substrate. Delayed alcoholism may lead to alcoholic ketoacidosis. Invokana promote absorption of glucose in the kidneys, and its subsequent release through the urinary tract when levels go too high. This initial stage of this condition can happen very quickly, in many cases in less than 24 hours. Disastrously, the medication also carries some more adverse reactions DKA includes:

  • Frequent urination
  • Urgent, burning, or painful urination
  • Urine that’s cloudy, pink, red, or brown
  • Urine that has a strong odor
  • Flushed face
  • Fruity-smelling breath

As per Food and Drug Administration (FDA) reports, more than 50 patients who were on Invokana medication discontinued the medications and saw some improvement, but it warned that kidney injury is not reversible in all situations. FDA advised that before prescribing Invokana or Farxiga, physicians and healthcare providers should screen patients for aspects that might incline them to kidney injury.


The Food and Drug Administration (FDA) approved this medicine in 2013. It’s manufactured by Janssen Pharmaceuticals, Inc. The manufacturers have failed to warn patients and doctors about the life threatening risk associated with the diabetic medicine Invokana. Health Canada will investigate on the available information and will figure out whether the changes are needed in the prescribing information for this class of drugs. Once the safety review completed Health Canada will communicate the results. As the investigation is in progress, the citizens of Canada are advised to report adverse reactions linked with Invokana to Health Canada. The medications should be discontinued if the symptoms occur and ketoacidosis is diagnosed. An appropriate action should be taken to treat the acidosis and monitor glucose levels.

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