U.S. FDA Adds Boxed Warning on Invokana Label Over Increased Risk of Foot/Leg Amputations

The U.S. Food and Drug Administration (FDA) has announced that it will be imposing new warnings, including a Boxed Warning, on canagliflozin products including Invokana, Invokamet, Invokamet XR (all marketed by Johnson & Johnson, J&J; U.S.) in light of new safety concerns observed in two large clinical trials (CANVAS and CANVAS-R). The prescription drugs are indicated for the treatment of type 2 diabetes, and were found to double the chances of leg and foot amputations

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