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December 4, 2015: FDA Orders Relabeling Due to SGLT2 Inhibitor Adverse Effects

SGLT2 Inhibitor News

After reports of adverse effects regarding the type-2 diabetes treatment SGLT2 inhibitors, the U.S. Food and Drug Administration (FDA) has announced that new warnings will be added to the labels of these types of medication. This announcement was the result of FDA review, which identified the risks associated with these medications, namely the possibility of ketoacidosis (too much acid in the blood) and of serious urinary tract infections (UTIs).
Between March, 2013 and May, 2015, according to the FDA’s Safety Communication, 73 cases of ketoacidosis were reported in diabetic patients being treated with SGLT2 inhibitors. Furthermore, “all patients required hospitalization or treatment in an emergency department.”

From March, 2013 through October, 2014, there were 19 reports of urinary tract infections developing into life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) in diabetics taking SGLT2 inhibitors.


Attorney Eric Weinberg has represented thousands of patients injured by drug adverse events including for example, the products Vioxx, Baycol, Pradaxa, Ortho Evra, and blood clotting products. If you or a loved one developed ketoacidosis or a blood or kidney infection after taking Invokana, Invokamet, or another SGLT2 inhibitor, please contact our firm for a free drug lawsuit evaluation by calling us toll free at 1-877-934-6274. You can also contact a Weinberg Firm lawyer by submitting our easy-to-use free legal case evaluation form.

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FDA Action on SGLT2 Inhibitor Diabetes Drug

In response to the risks of adverse effects, the FDA has required the addition of new Warnings and Precautions to the labels of all SGLT2 inhibitors. The updated labeling will describe the risk ketoacidosis and serious UTIs, as well as prescribing and monitoring recommendations. Additionally, the FDA ordered manufacturers of SGLT2 inhibitor diabetes drug to conduct post-marketing studies regarding the risk of these adverse effects.

Medicines in the SGLT2 inhibitor class

Brand name and Active ingredient(s)
Invokana – (canagliflozin)
Invokamet – (canagliflozin and metformin)
Farxiga – (dapagliflozin)
Xigduo XR – (dapagliflozin and metformin extended-release)
Jardiance – (empagliflozin)
Glyxambi – (empagliflozin and linagliptin)

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