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FDA Removes Boxed Warning About Risk of Leg and Foot Amputations for Canagliflozin (Invokana®)

August 26, 2020


Canagliflozin belongs to a class of medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. It is used in patients with Type 2 Diabetes to lower blood glucose.


Although the Boxed Warning will be removed, there is still an increased risk of leg and foot amputations. Healthcare professionals and patients should continue to recognize the importance of preventative foot care and monitor for new pain, tenderness, sores, ulcers, and infections in the legs and feet. Risk factors that may predispose patients to the need for amputation should be considered when choosing antidiabetic medicines.

Report adverse events involving this or other medicines to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).

Instructions for reporting can be found online at the NPTC Pharmacovigilance website.