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The communication states that this decision has not been made due to any safety concerns for the withdrawn or any continued indications.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.