FDA Removes Black Box Warning for Canagliflozin

August 26, 2020 – The U.S. FDA has removed a black box warning for canagliflozin-containing products regarding an increased risk of amputation. The warning was originally added to the drugs’ prescribing information in 2017. However, new clinical trial data suggests that the risk, while still present, is lower than previously believed.

Canagliflozin is an active pharmaceutical ingredient in Janssen’s Invokana® (canagliflozin), Invokamet® (canagliflozin/metformin), and Invokamet® XR (canagliflozin/metformin extended release). It is FDA- approved to treat diabetes, specifically to help lower blood sugar and to reduce the risk of serious cardiovascular events and worsening kidney function (including end-stage kidney disease).

The FDA still requires a description of the risk of amputation with canagliflozin in the Warnings and Precautions section of the prescribing information. This warning is less prominent than a black box warning, which is the FDA’s most stringent warning of the potential for adverse effects related to a medication’s use.

Healthcare professionals and patients should continue to practice preventative foot care and monitor for new pain, tenderness, sores, ulcers, and infections in the legs and feet. They should also consider risk factors that may predispose a patient to an eventual need for amputation when choosing medication to treat diabetes.