![]() Dapagliflozin remains authorised in adults for the treatment of type 2 diabetes, for the treatment of symptomatic chronic heart failure with reduced ejection fraction, and for the treatment of chronic kidney disease. Other indications for dapagliflozin 5mg and 10mg are not affected by this licensing change and both strengths will remain on the market. The decision was not driven by any new safety concerns, such as the already known increased risk of diabetic ketoacidosis in type 1 diabetes compared with type 2 diabetes. The decision by the marketing authorisation holder to voluntarily withdraw the indication in type 1 diabetes followed commercial considerations due to a specific European-wide regulatory requirement for this authorisation. As a result of the indication removal, the additional risk minimisation materials are no longer available. This reflected the increased risk in type 1 compared with type 2 diabetes, with studies in type 1 diabetes reporting diabetic ketoacidosis with a common frequency (may affect up to 1 in 10 patients), and cases reported of euglycaemic diabetic ketoacidosis. The use of dapagliflozin 5mg for the treatment of type 1 diabetes required specific additional risk minimisation measures for the risk of diabetic ketoacidosis, including a patient alert card and a healthcare professional guide. It should therefore be noted that a small increase in blood pressure may be seen upon discontinuation of dapagliflozin.ĭapagliflozin was the only SGLT2 inhibitor that was available for treatment of type 1 diabetes. ![]() As such, patients with type 1 diabetes should discontinue dapagliflozin 5mg in consultation with their specialist diabetes physician as soon as clinically practical.ĭapagliflozin has a diuretic effect and has been associated with a decrease in blood pressure. A letter was sent to UK healthcare professionals to inform them of the withdrawal. On 25 October 2021, the marketing authorisation holder for dapagliflozin withdrew the indication for type 1 diabetes across Europe and in the UK. ![]() For the full indications, see the Summary of Product Characteristics (SmPC).ĭapagliflozin (Forxiga) was authorised in 2019 as an adjunct to insulin in patients with type 1 diabetes with a body-mass index (BMI) of 27 kg per m2 or higher, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy. The SGLT2 inhibitor dapagliflozin has been indicated for the treatment of type 2 diabetes since 2012 and is also indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction and for the treatment of chronic kidney disease. Sodium glucose co-transporter 2 (SGLT2) inhibitors act to improve glycaemic control by reducing glucose reabsorption and increasing urinary glucose excretion. if you take dapagliflozin for your type 1 diabetes, your specialist will help you safely discontinue this treatment – you will need to monitor your blood glucose levels more closely to prevent hypoglycaemia or hyperglycaemia in the transition.this decision was not linked to a new safety issue and other patients using dapagliflozin for type 2 diabetes, heart failure, or chronic kidney disease can continue taking their medicine as recommended by a healthcare professional.the manufacturer of dapagliflozin (Forxiga) has voluntarily withdrawn its use in type 1 diabetes.always seek advice from your doctor or diabetes team before making changes to your diabetes medicines.report suspected adverse drug reactions associated with use of dapagliflozin on a Yellow CardĪdvice for healthcare professionals to give to patients and carers:. ![]() additional risk minimisation materials to mitigate the risks in patients with type 1 diabetes are no longer available.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.an increased insulin dose may be needed, which should be undertaken carefully to minimise the risk of hypoglycaemia or hyperglycaemia.after stopping dapagliflozin treatment, frequent blood glucose monitoring is recommended.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.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 5 mg is no longer authorised for the treatment of patients with type 1 diabetes mellitus.
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