FDAnews Drug Daily Bulletin

FDA Beefs Up Warning Labels for Canagliflozin and Dapagliflozin

June 21, 2016

The FDA is requiring stronger warning labels for Type 2 diabetes drug products that include canagliflozin — such as Invokana and Invokamet — and dapagliflozin — such as Farxiga and Xigduo XR — following reports affirming an increased risk for acute kidney damage.

Updated labeling includes information and factors to consider before taking the drugs to minimize the risk of kidney damage, including:

  • Decreased blood volume;
  • Chronic kidney insufficiency; and
  • Congestive heart failure.

The new warning labels also note that taking diuretics, blood pressure medicines and nonsteroidal anti-inflammatory drugs may increase the risk of kidney damage.

Between March 2013 and October 2015 – when canagliflozin was approved – the agency received reports of 101 cases of AKI, 73 for canagliflozin and 28 for dapaglifozin.

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