FDA removes canagliflozin boxed warning about risk of leg and foot amputations

FDA announced Wednesday that the boxed warning about amputation risk from canagliflozin (Invokana, Invokamet, Invokamet XR) has been removed from the drug’s prescribing information. The agency said the decision was based on its review of new data from three clinical trials. The reviews identified additional heart- and kidney-related benefits, which led to additional approved uses of the drug. Canagliflozin was approved in 2018 to reduce the risk of major heart-related events 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 disease, worsening of kidney function, heart-related death, and being hospitalized for heart failure in certain patients with type 2 diabetes and diabetic kidney disease. “Collectively, these newly identified effects of canagliflozin on heart and kidney disease show significantly enhanced benefit of this medicine,” FDA said in its Drug Safety Communication. “Safety information from recent clinical trials also suggests that the risk of amputation, while still increased with canagliflozin, is lower than previously described, particularly when appropriately monitored. Based upon these considerations, FDA has concluded that the boxed warning should be removed.” The new information is an update to a May 16, 2017, FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR). The agency recommends that health care providers and patients continue to recognize the importance of preventative foot care and pay attention to any new pain, tenderness, sores, ulcers, and infections in the legs and feet.