STORY FROM: Drugs & Medical Devices
FDA Strengthens Warnings of Acute Kidney Injury on Invokana, Farxiga Labels
June 15, 2016
WASHINGTON, D.C. — The Food and Drug Administration has strengthened the warning regarding the risk of acute kidney injury posed by type 2 diabetes drugs Invokana, Invokamet, Farxiga and Xigduo XR.
In response to recent reports, the agency has revised the warnings in the drug labels to include information about acute kidney injury and added recommendations, according to a June 14 Drug Safety Communication.
From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use,” the agency says. “This number ...