其 他 安 全 警 示
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| The United Kingdom: Dapagliflozin (Forxiga): no longer authorised for treatment of type 1 diabetes mellitus (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that the authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus.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.
Sodium glucose co-transporter 2 (SGLT2) inhibitors act to improve glycaemic control by reducing glucose reabsorption and increasing urinary glucose excretion. 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. Dapagliflozin (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.
On 25 October 2021, the marketing authorisation holder for dapagliflozin withdrew the indication for type 1 diabetes across Europe and in the UK. A letter was sent to UK healthcare professionals to inform them of the withdrawal. As such, patients with type 1 diabetes should discontinue dapagliflozin 5mg in consultation with their specialist diabetes physician as soon as clinically practical.
Dapagliflozin has a diuretic effect and has been associated with a decrease in blood pressure. It should therefore be noted that a small increase in blood pressure may be seen upon discontinuation of dapagliflozin.
Dapagliflozin was the only SGLT2 inhibitor that was available for treatment of type 1 diabetes.
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. 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. As a result of the indication removal, the additional risk minimisation materials are no longer available.
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. 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.
Other indications for dapagliflozin 5mg and 10mg are not affected by this licensing change and both strengths will remain on the market.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/dapagliflozin-forxiga-no-longer-authorised-for-treatment-of-type-1-diabetes-mellitus
In Hong Kong, there are 5 registered pharmaceutical products containing dapagliflozin. All these products are prescription only medicines and have not registered for the indication of treatment of type 1 diabetes mellitus. In light of the MHRA announcement, DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/ Saturday, Dec 11, 2021
Issued at HKT 13:00
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