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’.