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Invokana Poses 2X Leg, Foot Amputation Risk: FDA Black Box Warning

Canagliflozin was the first in a new class of type-2 diabetes drugs to work by forcing the kidneys to remove more sugar from the body in urine. Excessive urination can potentially cause dehydration and blood volume depletion in high-risk patients that exacerbates circulatory problems.

CANVAS and CANVAS-R, two large clinical trials that began in 2009 with 10,000 patients on canagliflozin or a placebo, released early data last year that prompted the FDA to warn about amputation risks.

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