FDA Removes Invokana Boxed Warning, Says New Data Show Heart, Kidney Benefits

WASHINGTON, D.C. — Citing new data from three clinical trials, the Food and Drug Administration has removed a boxed warning that type 2 diabetes drug Invokana, Invokamet (canagliflozin) poses an increased risk of leg and foot amputations.

The agency said the new data showed additional heart-and kidney-related benefits, which led to additional approved uses.

Specifically, in 2018, canagliflozin was approved to reduce the risk of major heart-related events such as heart attack, stroke, or death in patients with type 2 diabetes who have known heart disease. In 2019, the drug was approved to reduce the risk of end-stage kidney …