Updated Warning: FDA Warns of Diabetic Ketoacidosis and Serious Urinary Tract Infections with SGLT-2 Inhibitor Use

January 19, 2018. The US Food and Drug Administration (FDA) has identified further evidence supporting its May 2015 decision to revise the labeling for sodium-glucose cotransporter-2 (SLGT-2) inhibitors in patients with type 2 diabetes. Based on data submitted to the FDA’s Adverse Event Reporting System database, this update warns that use of these drugs may result in life-threatening diabetic ketoacidosis (DKA) and serious urinary tract infections (UTIs). In all identified cases (73 DKA and 19 UTIs), patients required emergency treatment or hospitalization. Some cases of DKA were not immediately recognized due to lower-than-typical blood glucose levels. All UTIs had progressed to blood (urosepsis) or kidney (pyelonephritis) infections. Both patients and practitioners must be vigilant and monitor for symptoms of UTI or elevated blood acid levels. The FDA has also mandated that the manufacturers of SGLT-2 inhibitors conduct 5-year postmarketing research programs to analyze spontaneous reports of DKA in patients using these drugs. You can read the FDA’s updated statement here.