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Information update

Forxiga, Invokana: Health Canada begins safety review of diabetes drugs known as SGLT2 inhibitors and risk of ketoacidosis

Starting date:
June 22, 2015
Posting date:
June 22, 2015
Type of communication:
Information Update
Source of recall:
Health Canada
Usage, Important Safety Information
General Public, Healthcare Professionals
Identification number:

Health Canada initiated a safety review for the prescription diabetes drugs dapagliflozin (Forxiga) and canagliflozin (Invokana) and the risk of ketoacidosis, a serious condition that leads to high levels of blood acids called ketones.

Dapagliflozin and canagliflozin are known as SGLT2 (sodium-glucose cotransporter-2) inhibitors and are approved in Canada for use in patients with type 2 diabetes to improve blood sugar levels, along with diet and exercise. 

Ketoacidosis predominantly develops in people with type 1 diabetes when insulin levels are too low, and is associated with high blood sugar levels. There have been international reports of ketoacidosis with the use of SGLT2 inhibitors in patients with type 2 diabetes who had only slightly increased blood sugar levels.

Because ketoacidosis is unexpected and can appear with only slightly increased blood sugar levels in people with type 2 diabetes, it is possible it may not be quickly identified or treated.

A preliminary search of Health Canada’s adverse reaction database identified one report of diabetic ketoacidosis involving the hospitalization of a 56-year old male taking an SGLT2 inhibitor. The patient was taking other medications at the time and further assessment will be conducted.

Health Canada will review the available information and will determine whether changes are needed in the prescribing information for this class of drugs. Health Canada will communicate the results of its review once it is complete. While the review is progressing, Health Canada is advising Canadians of this potential risk and encouraging them to report adverse reactions to Health Canada.

What you should do

  • Symptoms of ketoacidosis include difficulty breathing, feeling very thirsty, vomiting, abdominal pain, nausea, loss of appetite, confusion, and unusual tiredness. Seek urgent medical attention if you think you have these symptoms.
  • You should not stop treatment with Forxiga or Invokana without first consulting a healthcare professional.
  • Talk to your doctor or pharmacist if you have any concerns about your diabetic treatment.

What industry professionals should do

  • Evaluate patients with type 2 diabetes taking an SGLT2 who show signs of diabetic ketoacidosis regardless of blood sugar levels.
  • Treatment with an SGLT2 inhibitor should be discontinued if acidosis is confirmed, and appropriate measures should be taken to treat the acidosis and monitor sugar levels.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

  • Call toll-free at 1-866-234-2345
  • Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

SGLT2 Inhibitors [INVOKANA (canagliflozin), FORXIGA (dapagliflozin), XIGDUO (dapagliflozin/metformin), JARDIANCE (empagliflozin)] - Risk of Diabetic Ketoacidosis

2016-05-16 | Health products


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