FDA Adds New Warnings on SGLT2 Inhibitors for Diabetes

December 7, 2015 — The FDA has updated the label on diabetes drugs in the sodium-glucose cotransporter 2 (SGLT2) inhibitor class to warn about side effects like ketoacidosis and serious urinary tract infections.

In May 2015, the FDA issued a Safety Communication to warn about ketoacidosis. The agency received 73 reports of ketoacidosis in patients on SGLT2 inhibitors from March 2013 through May 2015.

The FDA also received 19 reports of potentially fatal blood infections (urosepsis) and kidney infections (pyelonephritis) that began as urinary tract infections. All of the patients were hospitalized and a few required intensive care or dialysis for kidney failure.

Ketoacidosis associated with SGLT2 inhibitors can occur even if blood-sugar levels are not very high. According to the FDA:

“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.”

Medications in the SGLT2 inhibitor class include canagliflozin (Invokana, Invokamet), dapagliflozin (Farxiga), and empagliflozin (Jardiance). This new class of drugs improves blood-sugar control by increasing insulin sensitivity and the absorption of sugar by muscle cells.

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