The FDA is requiring new warnings, including a boxed warning, be added to the canagliflozin drug labels to describe this risk.
Patients taking canagliflozin are being asked to notify their healthcare professionals if they develop any new pain, tenderness, sores, ulcers or infections in their feet or legs. Healthcare professionals should consider factors that may predispose patients to the need for amputations, such as a history of prior amputation, peripheral vascular disease, neuropathy and/or diabetic foot ulcers, before starting a patient on canagliflozin. Patients taking canagliflozin should be monitored for signs and symptoms indicative of these predisposing conditions, and canagliflozin should be discontinued if they arise.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- Bally M, Dendukuri N, Rich B, et al. Risk of acute myocardial infarction with NSAIDs in real world use: Bayesian meta-analysis of individual patient data. BMJ. 2017 May 9;357:j1909. doi: 10.1136/bmj.j1909.
- U.S. Food and Drug Administration. FDA drug safety communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR). 2017 May 16.
