Dapagliflozin (Forxiga): no longer authorised for treatment of type 1 diabetes mellitus

Author: 
Dr Hermione Price, ABCD Committee
Date of the announcement: 
Monday, 13 December, 2021

As of 25th October 2021, dapagliflozin 5mg is no longer authorised for the treatment of people with type 1 diabetes mellitus (T1DM) and should no longer be used in this population . This is based on AstraZeneca’s decision to remove the Type 1 diabetes indication for dapagliflozin 5mg.

ABCD are disappointed that the use of dapaglifozin has been withdrawn for people with type 1 diabetes. 

This is not due to any safety concern for dapagliflozin in any indication, including people with type 1 diabetes.

The use of dapagliflozin should be reviewed and discontinued inplans to discontinue treatment must be discussed with people  patients with type 1 diabetes in consultation with a physician specialised in diabetes care as soon as clinically practical as per MHRA instructions1 .

The pro-active contacting of people with type 1 diabetesatients is recommended, and this may be best done in collaboration with primary care colleagues.

Whilst, as per MHRA instructions, it is recognised that routine use of dapagliflozin should be discontinued in people with type 1 diabetes, ABCD recognises that there will be instances in which the treating physician and person with type 1 diabetes agree that the benefits of continued off-licence administration of dapagliflozin outweigh the risks, including that of diabetic ketoacidosis, and is supportive of this individualised approach. 

In these cases, the rationale and risk versus benefit discussion should be clearly documented in medical records and clearly communicated to the general practitioner whose consent to continue prescribing dapagliflozin would be required.

If using dapagliflozin in people with type 1 diabetes, strategies for mitigating the risk of diabetic ketoacidosis must be supported by healthcare practitioners. These include blood ketone monitoring and ensuring the provision of education regarding the STITCH protocol2 that involves the administration of insulin, carbohydrates and fluids once ketosis has been detected.

After stopping dapagliflozin treatment, frequent blood glucose monitoring is advised, and insulin doses may need to be carefully increased to minimise risks of hyperglycaemia.

  1. https://www.gov.uk/drug-safety-update/dapagliflozin-forxiga-no-longer-au...
  2. Strategy for Mitigating DKA Risk in Patients with Type 1 Diabetes on Adjunctive Treatment with SGLT Inhibitors: A STICH Protocol - PubMed (nih.gov) https://care.diabetesjournals.org/content/42/6/1147

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