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EMA makes recommendations to minimise risk of DKA in people receiving SGLT2 inhibitors

The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee has finalised a review of sodium–glucose cotransporter 2 (SGLT2) inhibitors and has made recommendations to minimise the risk of diabetic ketoacidosis (DKA).

Rare cases of this condition have occurred in people taking SGLT2 inhibitors for type 2 diabetes, and a number of these cases have been atypical, with patients not having blood sugar levels as high as expected. In order to minimise this risk, the Committee has made the following recommendations.

  • An atypical presentation of diabetic ketoacidosis can delay diagnosis and treatment. Healthcare professionals should therefore consider the possibility of DKA in people taking SGLT2 inhibitors who have symptoms consistent with the condition even if blood sugar levels are not high.
  • Patients taking any of these medicines should be aware of the symptoms of DKA and contact their healthcare professional if they have any of these symptoms:
    – Rapid weight loss.
    – Nausea or vomiting.
    – Stomach pain.
    – Excessive thirst.
    – Fast and deep breathing.
    – Confusion.
    – Unusual sleepiness or tiredness.
    – A sweet smell to the breath.
    – A sweet or metallic taste in the mouth.
    – A different odour to urine or sweat.
  • If diabetic ketoacidosis is suspected or confirmed, treatment should be stopped immediately and should not be re-started unless another cause for the DKA is identified and resolved.
  • Healthcare professionals should exercise caution in patients with risk factors for DKA and inform them of the risk factors, including the following:
    – Low reserves of insulin-secreting cells.
    – Conditions that restrict food intake or can lead to severe dehydration.
    – A sudden reduction in insulin or an increased requirement for insulin due to illness, surgery or alcohol abuse.
  • SGLT2 inhibitor treatment should be temporarily stopped in people hospitalised for major surgical procedures or due to serious illness.
  • Finally, the Committee reminds practitioners that these medicines are not authorised for treating type 1 diabetes, noting that some cases of DKA had occurred with off-label use.

The Committee’s recommendations will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) for the adoption of the EMA’s final opinion. Further details will be published at the time of the CHMP opinion.

The recommendations can be viewed in full here.

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