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News From the Food and Drug Administration
January 19, 2016

Update on SGLT2 Inhibitor Warning

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Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;315(3):243. doi:10.1001/jama.2015.18729

The FDA has added warnings to sodium-glucose cotransporter 2 (SGLT2) inhibitor labels concerning increased risks of ketoacidosis and serious urinary tract infections.

Used to treat type 2 diabetes, SGLT2 inhibitors were the subject of a May 2015 warning that addressed risks associated with the drugs. At that time, a search of the FDA Adverse Event Reporting System (FAERS) turned up 20 cases of diabetic ketoacidosis, ketoacidosis, or ketosis linked with SGLT2 inhibitors between March 2013 and June 2014 ( More extensive FAERS data from March 2013 to May 2015 identified a total of 73 cases of ketoacidosis in patients with type 1 or 2 diabetes who took an SGLT2 inhibitor (

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