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diabetes3February 17 2016

Patients with diabetes who are at risk of diabetic ketoacidosis should exercise caution if taking SGLT2 inhibitors or glifozin medicines for their diabetes.

The European Medicines Agency has issued the warning following a review of data on the type 2 diabetes drug class. Three of the drugs - canagliflozin, dapagliflozin and empagliflozin - are licensed for use in the EU, either alone or in combination with metformin, under the following brand names: Ebymect, Edistride, Forxiga, Invokana, Jardiance, Synjardy, Vokanamet and Xigduo.

“Patients taking any of these medicines should be aware of the symptoms of diabetic ketoacidosis, including 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, or a different odour to urine or sweat,” said EMA.

“If diabetic ketoacidosis is suspected or confirmed, treatment should be stopped immediately and should not be re-started unless another cause for the ketoacidosis is identified and resolved.”

In addition, EMA is advising healthcare professionals to exercise caution in patients with risk factors for ketoacidosis and inform patients of the risk factors. “These include low reserve 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.”

The recommendations have been made following the conclusion of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) review of SGLT2 inhibitors. PRAC has also recommended temporarily stopping SGLT2-inhibitor treatment in patients in hospital for major surgical procedures or due to serious illness.

It concluded that the benefits of SGLT2 inhibitors continue to outweigh their risks in the treatment of type 2 diabetes. It has reminded healthcare professionals that these medicines are not authorised for treating type 1 diabetes, although some cases of ketoacidosis had occurred with off-label use.

In a separate announcement, NICE has published final diagnostics guidance recommending the MiniMed Paradigm Veo System (Medtronic) for managing blood glucose levels in some people with type 1 diabetes.

The MiniMed Paradigm Veo system comprises a glucose sensor implanted under the skin to continuously measure glucose levels, an insulin pump to deliver insulin continuously, and a transmitter to send glucose level readings wirelessly from the sensor to the pump. It alerts the patient if glucose levels are too high or low, and will suspend insulin delivery for two hours if the patient does not respond to the alert.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said that one of the greatest fears for people with type 1 diabetes and their carers is severe hypoglycaemia. “This can have a substantial impact on quality of life by leading people to restrict their daily activities. It can also cause significant anxiety for carers, particularly parents who may have to wake several times a night to check on their child.

“The committee concluded that using the MiniMed Paradigm Veo System may help people with type 1 diabetes improve their glucose control and as a result may reduce the number of diabetes-related complications they experience and improve their quality of life. Using the system may also make it easier for people to stick to their treatment.”

Links:

EMA announcement

NICE announcement

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