Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
The link between diabetic ketoacidosis (DKA) and SGLT2 inhibitor treatment for type 1 and type 2 diabetes has been previously established through studies conducted by the EMA and the American Diabetes Association.
For more information on the EMA's warning, see my previous article, "EMA Advises How to Reduce DKA Risk While Taking SGLT2 Inhibitors." Information from the American Diabetes Association on the link between DKA and Invokana / Invokamet, specifically, can be found in my article, "Canagliflozin Also Causes DKA in Those With Type 1 Diabetes."
On May 16, 2016, Health Canada released additional information regarding the SGLT2 inhibitors Invokana, Farxiga / Forxiga (Europe), Xigduo, and Jardiance. In their article, they provide the following information:
- Serious, sometimes life-threatening and fatal cases of diabetic ketoacidosis (DKA) have been reported in patients on sodium glucose co-transporter 2 (SGLT2) inhibitors for type 1 and type 2 diabetes.
- In a number of these cases, the presentation of the condition was atypical with only moderately increased blood glucose levels observed.
- SGLT2 inhibitors are NOT indicated for treatment of type 1 diabetes mellitus and should not be used in type 1 diabetes.
- It is recommended that:
- if DKA is suspected or diagnosed, treatment with SGLT2 inhibitors should be discontinued immediately.
- SGLT2 inhibitors should not be used in patients with a history of DKA.
- in clinical situations known to predispose to ketoacidosis (e.g. major surgical procedures, serious infections and acute serious illness), consideration be given to temporarily discontinuing SGLT2 inhibitor therapy.
- patients be informed of the signs and symptoms of DKA and be advised to immediately seek medical attention if they develop them.
- caution be used before initiating SGLT2 inhibitor treatment in patients with risk factors for DKA.
In summary, Health Canada states that patients with type 1 and type 2 diabetes mellitus who have used SGLT2 inhibitors are at an increased risk for DKA, according to clinical trials and reported post-market cases. Additionally, the majority of the patients involved in the aforementioned trials and reports required hospitalization, many after taking SGLT2 inhibitors for only two months.
They also found that among some patients diagnosed with DKA after using SGLT2 inhibitors, their blood glucose levels were only moderately increased. As such, there is a higher chance of delayed diagnosis and treatment, putting the patient at greater risk for hospitalization, and even death.
Health Canada gives the following warning to those taking Invokana, Farxiga / Forxiga (Europe), Xigduo, or Jardiance:
Patients taking any of these medicines should be aware of the symptoms of DKA, including loss of appetite, nausea or vomiting, stomach pain, feeling very thirsty, rapid breathing, confusion, feeling unusual tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.
Patients should immediately seek medical advice if they develop any of these symptoms. Patients should also inform their healthcare professional about medical issues or factors (see below) that may predispose them to ketoacidosis.
We will continue to monitor the medical literature concerning these SGLT2 inhibitors and an increased risk of DKA, and report on any additional findings.
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More articles on this topic:
- Canagliflozin Also Causes DKA in Those With Type 1 Diabetes
- EMA Advises How to Reduce DKA Risk While Taking SGLT2 Inhibitors
- U.S. FDA warns on newer class of type 2 diabetes drugs