European Medicines Agency issues statement on link between SGLT2 inhibitors and diabetic ketoacidosis

Kurt Wood
Mon, 22 Feb 2016
European Medicines Agency issues statement on link between SGLT2 inhibitors and diabetic ketoacidosis
The European Medicines Agency (EMA) has urged healthcare professionals to pay attention to signs of diabetic ketoacidosis (DKA) in people with type 2 diabetes who are taking SGLT2 inhibitors.

These drugs, which in the UK are available under the trade names Forxiga (dapagliflozin), Invokana (canagliflozin) and Jardiance (empagliflozin), are designed to lower blood glucose levels in people with type 2 diabetes.

Since mid-2015, there have been concerns that SGLT2 inhibitors are a risk factor for DKA in people with type 2 diabetes. DKA is a serious short-term complication usually associated with type 1 diabetes. It normally occurs when blood glucose levels are extremely high.

However, a study published in the journal Diabetes Care identified "an increased risk of diabetic ketoacidosis (DKA) with uncharacteristically mild to moderate glucose elevations [...] associated with the use of all the approved [SGLT2 inhibitors]." In other words, these cases of DKA were not associated with significantly elevated blood glucose levels; this phenomenon is known as euglycemic diabetic ketoacidosis.

The safety concerns surrounding SGLT2 inhibitors prompted the US Food and Drug Administration (FDA) to issue a notice. Shortly after, the EMA conducted its own review, through which it identified that more than 100 people taking SGLT2 inhibitors had developed DKA.

The EMA has now released a statement in which it advises doctors to look out for symptoms of DKA in people with type 2 diabetes taking SGLT2 inhibitors, even if they don't have high blood glucose levels. It lists the symptoms and explains the risk factors associated with DKA.

"Healthcare professionals should exercise caution in patients with risk factors for ketoacidosis and inform patients of the risk factors," the document states. "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."

However, the statement also points out that the benefits of SGLT2 inhibitors - Forxiga, Invokana and Jardiance - consistently outweigh the relatively slim risk of DKA. Although SGLT2 treatment should be discontinued immediately if you show signs of DKA, you should carry on adhering to the treatment until then.

The statement can be accessed here.
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