The European Medicines Agency (EMA) has finalised a review of Type 2 diabetes medications canagliflozin, dapagliflozin and empagliflozin (1).
The review was requested by the European Commission following over a hundred cases ofdiabetic ketoacidosis(DKA) in patients treated with these medicines, known as SGLT2 inhibitors.
Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels. Rare cases of this condition, including life-threatening ones, have occurred in patients 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.
The EMA has advised that 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.
Patients should contact their healthcare professional if they have any of these symptoms.
Healthcare professionals are advised 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.
In addition the EMA recommends temporarily stopping SGLT2 inhibitor treatment in patients in hospital for major surgical procedures or due to serious illness.
Simon O’Neill, Diabetes UK Director of Health Intelligence, said: “The number of reported cases of diabetic ketoacidosis in patients treated with SGLT2 inhibitors is very small and the benefits of these Type 2 medicines continue to outweigh the risks. However, it is important that patients consult their doctor if they feel unwell and their blood glucose levels go high. We also want healthcare professionals to be aware of this review and particularly that DKA may occur in these patients without them having very high blood glucose levels. Patient safety is of paramount importance.”
(1) The three SGLT2 inhibitors authorised in the UK are available (alone or in combination with other Type 2 medications) under the following tradenames: Forxiga, Invokana and Jardiance.