On May 16, the Food and Drug Administration (FDA) issued a new warning about the diabetes drug Invokana. Now, the FDA “has concluded” based on tests that the drug presents an increased risk of foot and leg amputations. Specifically, the FDA safety alert says:
Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.