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FDA Updates Safety Label on SGLT2 Inhibitors

Dec 7, 2015

The U.S. Food and Drug Administration (FDA) is updating the safety label on sodium-glucose cotransporter-2 (SGLT2) inhibitors to warn about the risk of ketoacidosis and serious urinary tract infections. SGLT2 inhibitors are used to lower blood sugar in patients who have type 2 diabetes. The FDA announcement follows up on a previous safety alert issued in May. Ketoacidosis, a condition in which the blood is too acidic due to production of ketone bodies, and serious urinary tract infections can both result in hospitalization.

The FDA warns that signs of ketoacidosis include nausea, vomiting, abdominal pain, tiredness and difficulty breathing. Symptoms of urinary tract infection include feeling the need to urinate often or immediately and a burning sensation while urinating. A urinary tract infection may also cause pain in the lower abdominal or pelvic area, fever and blood in the urine. Patients should seek medical attention if they experience these symptoms.

According to the FDA alert, physicians should test for ketoacidosis and urinary tract infections in patients taking SGLT2 inhibitors with symptoms of these conditions. SGLT2 inhibitor-linked ketoacidosis may occur even when blood sugar levels are not elevated.

The FDA warned about the risk of ketoacidosis with SGLT2 inhibitors in May. An FDA review of its Adverse Event Reporting System (FAERS) identified 73 cases of ketoacidosis among diabetic patients taking SGLT2 inhibitors between March 2013 and May 2015. Since the database only includes cases that were reported to the FDA, it is likely that this number is an underestimation. "All patients required hospitalization or treatment in an emergency department. In many cases, ketoacidosis was not immediately recognized because the blood glucose levels were below those typically expected for diabetic ketoacidosis. As a result, treatment of the ketoacidosis was delayed in some cases." the FDA said.

Between March 2013 and October 2014, the FDA identified 19 cases of urinary tract infections that led to urosepsis, life-threatening blood infections, and kidney infections. "All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure." the FDA stated. In addition to the label update, the FDA is requiring manufacturers of SGLT2 inhibitors to conduct a post marketing study.

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