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Dapagliflozin - no longer authorised for treatment of type 1 diabetes mellitus in Europe and the UK

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

Authoring team

In Europe and the UK authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus. The removal of the type 1 diabetes indication is not due to any new safety concerns and the other indications of dapagliflozin are unchanged (1)

Advice for healthcare professionals:

  • dapagliflozin 5 mg is no longer authorised for the treatment of patients with type 1 diabetes mellitus
  • the removal of the type 1 diabetes indication is not due to any new safety concerns and the other indications of dapagliflozin are unchanged
  • dapagliflozin should be reviewed and discontinued in patients with type 1 diabetes by or in consultation with a physician specialised in diabetes care as soon as clinically practical
  • after stopping dapagliflozin treatment, frequent blood glucose monitoring is recommended
  • an increased insulin dose may be needed, which should be undertaken carefully to minimise the risk of hypoglycaemia or hyperglycaemia
  • diabetic ketoacidosis is a known risk with use of dapagliflozin in all patients with diabetes, but it occurs more frequently in patients with type 1 diabetes than those with type 2 diabetes
  • additional risk minimisation materials to mitigate the risks in patients with type 1 diabetes are no longer available
  • report suspected adverse drug reactions associated with use of dapagliflozin on a Yellow Card

Advice for healthcare professionals to give to patients and carers:

  • always seek advice from your doctor or diabetes team before making changes to your diabetes medicines
  • the manufacturer of dapagliflozin (Forxiga) has voluntarily withdrawn its use in type 1 diabetes
  • this decision was not linked to a new safety issue and other patients using dapagliflozin for type 2 diabetes, heart failure, or chronic kidney disease can continue taking their medicine as recommended by a healthcare professional
  • if you take dapagliflozin for your type 1 diabetes, your specialist will help you safely discontinue this treatment – you will need to monitor your blood glucose levels more closely to prevent hypoglycaemia or hyperglycaemia in the transition

Reference

  • Drug Safety Update volume 15, issue 5: December 2021: 3.

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