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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Dapagliflozin no longer indicated in T1DM

The manufacturer of dapagliflozin (Forxiga®) has written to healthcare professionals advising that dapagliflozin 5mg is no longer recommended in patients with Type 1 Diabetes Mellitus. The other licensed indications are unaffected.

The communication states that this decision has not been made due to any safety concerns for the withdrawn or any continued indications. The letter goes on state that DKA was reported in studies at a rate of at least 1 per 100 patients. Additional risk minimisation measures have always been recommended with patient alert cards and guides for healthcare professionals made available. With the removal of this indication, the risk minimisation materials will no longer be available.

It is recommended that the treatment is reviewed and discontinued by or in consultation with a specialist and that this is done as soon as clinically practical.

Action: Clinicians should be aware of this license change. It would be prudent to run clinical system searches to identify any patients who are currently prescribed this product to allow a review.

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4 Comments to “Dapagliflozin no longer indicated in T1DM”

  1. Link to the AZ communication:
    https://assets.publishing.service.gov.uk/media/619374948fa8f5037ffaa083/20211102-uk-dhpc-forxiga-T1D-withdrawal.pdf

    The NICE TA has indeed now been withdrawn.

    Comment by Andrew Martin — November 17, 2021 #
    Reply

    1. @Andrew,

      Thanks for finding that link, very helpful.

      Comment by Matthew Robinson — November 17, 2021 #
      Reply

  2. I guess this has just trashed NICE TA 597.

    Comment by Andrew Martin — November 10, 2021 #
    Reply

    1. @Andrew,

      Indeed. I expect NICE will be withdrawing that TA at some point.

      Comment by Matthew Robinson — November 11, 2021 #
      Reply

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