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The U.S. Food and Drug Administration released a safety communication informing the public of stronger kidney injury warning labels on SGLT2 inhibitors that treat Type 2 diabetes, including J&J’s Invokana/Invokamet (Canagliflozin) and Farxiga/Xigduo XR.
“Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk,” the FDA said.
From the time the FDA approved these medications in 2013 to 2015, the agency received 101 reports of acute kidney injury — 73 caused by Invokana and 28 by Farxiga. Of these cases, 96 patients required hospitalization, and 22 of these cases required admission to intensive care.
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