Dapagliflozin no longer indicated for type I diabetes

Forxiga 5mg tablets were previously indicated as an adjunct to insulin for the treatment of type I diabetes in adults with a BMI ≥27kg/m² when optimal therapy with insulin alone was inadequate, but they should no longer be used in this setting. The other licensed indications are unaffected.

The risk of diabetic ketoacidosis is increased in patients with type I diabetes; however, the manufacturer of Forxiga says the withdrawal of the SGLT2 inhibitor is not due to any safety concerns in type I diabetes or any other indications. In pooled data from two placebo-controlled studies in type I diabetes, diabetic ketoacidosis was reported in 4% of patients who received dapagliflozin and 1.1% of those who received placebo.

It is recommended that use of dapagliflozin in patients with type I diabetes is reviewed and discontinued by or in consultation with a specialist and that this is done as soon as clinically practical.

With the removal of the type I diabetes indication, the previously published risk minimisation materials for the drug will no longer be available.