Study Finds Invokana Increases Ketones in T1 Diabetics

April 15, 2016 — Diabetes Care has published a study linking the use of Invokana (canagliflozin) with an increased risk of diabetic ketoacidosis (DKA). Ketone-related adverse events occurred in 5-10% of type-1 diabetic patients on 100-mg or 300-mg doses in addition to insulin.

The study involved 351 people with type-1 diabetes who used insulin injections were randomly assigned to take Invokana (100-mg or 300-mg doses) or a placebo once a day before breakfast.

After 18 weeks, 5.1% of patients on the 100-mg dose and 9.4% of patients on the 300-mg dose had suffered any ketone-related adverse event. Furthermore, serious events of ketoacidosis requiring hospitalization occurred in 4.3% of patients on the 100-mg dose and 6% on the 300-mg dose.

The FDA warns that patients on Invokana can develop ketoacidosis even when blood-sugar levels are normal or only slightly elevated. Of the 12 patients who were hospitalized with severe ketoacidosis, five patients had blood-sugar levels under 13.9 mmol/L, which is the standard threshold to diagnose ketoacidosis.

All of the patients who developed severe ketoacidosis missed a dose of insulin or had other health problems, such as influenza, pneumonia, infusion-site infection, food poisoning, insulin pump failure/malfunction, noncompliance with insulin regimen, or decrease in food intake.

Invokana (canagliflozin) is not approved for patients with type-1 diabetes. In September 2015, the FDA revised the label to warn about the risk of ketoacidosis. From March 2013 to May 2015, the agency identified 73 cases of ketoacidosis in patients with type-1 or type-2 diabetes. All of the patients required hospitalization or treatment in an emergency department. In many cases, diagnosis was delayed because blood-sugar levels were relatively normal.

According to the FDA, risk-factors for ketoacidosis include major illness, reduced food and fluid intake, and missing a dose of insulin. The agency recommends:

“Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.”

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