TGA statement regarding SGLT2 inhibitors – Safety Advisory

The Therapeutic Goods Administration has recently published information regarding SGLT2 inhibitors titled Sodium glucose co-transporter 2 inhibitors – used to treat type 2 diabetes – Safety advisory – risk of diabetic ketoacidosis.

The statement notes that:

Consumers and health professionals are advised 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 sugar levels in patients with type 2 diabetes.

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.

Affected brands include:

The sponsors of these medicines have jointly written to health professionals to provide further information about this issue, including recommendations for patient management.

The entire TGA statement can be found at: https://www.tga.gov.au/alert/sodium-glucose-co-transporter-2-inhibitors-used-treat-type-2-diabetes

TGA statement regarding SGLT2 inhibitors – Safety Advisory

The Therapeutic Goods Administration has recently published information regarding SGLT2 inhibitors titled Sodium glucose co-transporter 2 inhibitors – used to treat type 2 diabetes – Safety advisory – risk of diabetic ketoacidosis.

The statement notes that:

Consumers and health professionals are advised 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 sugar levels in patients with type 2 diabetes.

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.

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.

The entire TGA statement can be found at: https://www.tga.gov.au/alert/sodium-glucose-co-transporter-2-inhibitors-used-treat-type-2-diabetes