The FDA has required new Boxed Warning labels on medications that contain canagliflozin. These include Invokana, Invokamet, and Invokamet XR. Two large clinical trials showed that leg and foot amputations occurred almost twice as often in patients treated with canagliflozin compared to those treated with placebo. The most common types were amputations of the toe and middle of the foot.

Before starting a medication that contains canagliflozin, health care professionals should consider factors that may predispose patients to the need for amputations including a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.

For patients taking a medication containing canagliflozin, they are recommended to notify their health care professionals immediately if they develop new pain/tenderness, sores/ulcers, or infections in legs or feet.

Click here to view the full article released be the FDA.