In Europe and the UK authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus.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- the manufacturer of dapagliflozin (Forxiga) has voluntarily withdrawn its use in type 1 diabetes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.