FDA Adds New Warnings Regarding Ketoacidosis and Infections to SGLT2 Type 2 Diabetes Drugs

WASHINGTON, D.C. — The Food and Drug Administration has added new warnings to the labels of sodium-glucose cotransporter-2 (SGLT2) inhibitors regarding the risks of too much acid in the blood and of serious urinary tract infections, following a safety review of the type 2 diabetes drugs.

In a Dec. 4 Drug Safety Communication, the agency explained that a review of the FDA Adverse Event Reporting System database from March 2013 to May 2015 identified 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors.

In May, the agency issued a warning about the …