The FDA is requiring new warnings, including a Boxed Warning, to be added to type 2 diabetes medicine canagliflozin drug labels to describe the increased risk of leg and foot amputations. The FDA drew its conclusions from new data from 2 large clinical trials; the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus), which showed that leg and foot amputations occurred twice as often in patients treated with canagliflozin compared to patients treated with placebo. The FDA has issued the following recommendation for health care professionals:

• Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur.