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Drugs regulator to review safety of gliflozins for type 2 diabetes patients

The European drugs regulatory body has launched a review of the group of diabetes drugs known as SGLT2 inhibitors – or gliflozins – following cases of diabetic ketoacidosis among patients with type 2 diabetes taking the drugs.

The European Medicines Agency (EMA) said it was conducting the review after 101 cases of diabetic ketoacidosis - a condition usually seen in patients with type 1 diabetes - were reported worldwide in patients with type 2 diabetes using the drugs to help control their blood glucose.

All the cases were serious and some required patients to be admitted to hospital, the EMA said, while some patients’ blood glucose levels were not elevated as is usually characteristic of the condition, potentially delaying diagnosis and treatment.

SGLT2 (sodium-glucose co-transporter-2) inhibitors lower blood sugar by increasing the amount of glucose that is removed via the kidneys.

The regulator said it was writing to GPs and other clinicians about the risk of diabetic ketoacidosis and how to manage it and that ‘patients who have any concerns about their diabetes medicines should consult their doctor or pharmacist’.

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Readers' comments (5)

  • Could this seriously be missed in trials before being licensed?

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  • I suspect this is not a drug effect at all but some other factor is at play Press will love it Patients will worry Probably nought will come of it Time will tell

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  • Vinci Ho

    Yes
    Like to know more about this
    SGLT2 inhibitors in general , has not worked very successfully on my type 2 diabetic patients.....

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  • I find it can work well and result in weight loss. Lots of side effects though with GU tract

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  • Samuel Lewis

    And still we wait for outcomes evidence.. not a single rct.
    I would not use it till I see the evidence.

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