TGA Safety Alert for sodium glucose co-transporter 2 inhibitors used to treat type 2 diabetes
TGA Safety Alert for sodium glucose co-transporter 2 inhibitors
used to treat type 2 diabetes
Safety advisory – risk of diabetic ketoacidosis
14 August 2015
The Therapeutic Goods Administration (TGA) is advising consumers and health professionals
that serious cases of diabetic ketoacidosis (DKA) have been reported in patients taking
prescription medicines that are inhibitors of sodium glucose co-transporter 2 (SGLT2).
These medicines include canagliflozin, dapagliflozin or empagliflozin, which are used to help
lower blood glucose levels in patients with type 2 diabetes.
The TGA has advised that:
Early signs and symptoms of DKA include abdominal pain, nausea, vomiting, anorexia,
excessive thirst, difficult breathing, unusual fatigue and sleepiness. If DKA is not diagnosed
early and treatment initiated, more serious signs and symptoms including dehydration, deep
gasping breathing, confusion and coma can potentially develop.
DKA occurs most commonly in patients with type 1 diabetes, although it can occur in type 2
diabetes. It is usually accompanied by high blood glucose levels.
However, in a number of the cases of DKA associated with SGLT2 inhibitors, patients
demonstrated only a moderately increased blood glucose level. This could lead to delayed
diagnosis and treatment...
...If you or someone you care for takes one of the affected products, you should continue taking
your medicine until advised otherwise by your health professional. However, if you experience
abdominal pain, nausea, vomiting, anorexia, excessive thirst, difficulty breathing, confusion,
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TGA Safety Alert for sodium glucose co-transporter 2 inhibitors used to treat type 2 diabetes
unusual fatigue or sleepiness, you should immediately seek medical advice.
Affected brands include:
- Invokana (canagliflozin) tablets – 100 mg and 300 mg
- Forxiga (dapagliflozin) tablets – 10 mg
- Xigduo XR (dapagliflozin and metformin hydrochloride XR) tablets – 5 mg/1000 mg, 10
mg/1000 mg and 10 mg/500 mg
- Jardiance (empagliflozin) tablets – 10 mg and 25 mg.
The sponsors of these medicines have jointly written to health professionals to provide further
information about this issue, including recommendations for patient management. This
information relates to a potential risk associated with these medicines.
If you have any questions or concerns about this issue, speak to your diabetes healthcare team.
To view the original TGA alert, please click here .
The National Diabetes Services Scheme (NDSS) is an initiative of the Australian Government
administered with the assistance of Diabetes Australia.
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