Forxiga (dapagliflozin) no longer authorised for treatment of type 1 diabetes

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Amity Island

Amity Island

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Type 1
  • 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

www.gov.uk

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

The authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus.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.
www.gov.uk www.gov.uk
 
I don’t know if any of our T1s have been prescribed Forxiga, but I do know it was contraindicated in T1 in the US in 2014, so I’m amazed it was ever approved (with cautions) in the UK.

It’s mode of action, in reducing the volume of fluid in the body, is an obvious route to DKA. Anyone can see that. Any doctor who prescribed this to a T1 patient should be forced to do 3 years forced re-education and his/her licence to practice suspended until completed.
 
@peedee76 - you are literally the first T1 I have ever 'met' on a forum who has taken it. What problems did it sort out for you which couldn't be sorted any other way?
 
Is it specifically that one or the whole category of drugs? I had DKA from empagliflozin within a week and was surprised they were authorised for anyone on MDI really.
 
Lucyr said:
Is it specifically that one or the whole category of drugs? I had DKA from empagliflozin within a week and was surprised they were authorised for anyone on MDI really.
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Dapagliflozin 5mg was the only SGL2 authorised for use in T1 and the manufacturers have withdrawn it themselves - it was always said upfront it made minimal difference anyway so the cons (DKA etc) always outweighed the pros anyway, it seems to me.
 
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