Risk of lower limb amputations (primarily of the toes) during treatment with INVOKANA™ (canagliflozin)

Janssen would like to inform healthcare professionals of the risk of lower limb amputations (primarily of the toes) during treatment with INVOKANA™ (canagliflozin). A two-fold higher incidence of lower limb amputations (primarily of the toes) has been observed in patients treated with canagliflozin in the CANVAS study, an ongoing long-term cardiovascular outcomes trial of type 2 diabetes patients who are at high risk for cardiovascular events. The increased risk is independent of predisposing risk factors, although the absolute risk was higher in patients with previous amputations, existing peripheral vascular disease or neuropathy. Dehydration and volume depletion might also play a role in the development of lower limb amputations during treatment with canagliflozin. Healthcare professionals are reminded to follow standard diabetes treatment guidelines for routine preventive foot care, and to monitor patients for signs and symptoms of volume depletion and those with risk factors for amputation events during treatment with INVOKANA™. Early recognition and treatment should be initiated for foot problems and consideration should be given to stop INVOKANA™ treatment in patients who develop significant complications at least until the condition has resolved. Please refer to the letter for more details. 
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

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Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

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