BioCentury
ARTICLE | Clinical News

FDA adds amputation risk boxed warning to Type II diabetes drug canagliflozin

June 2, 2017 7:16 PM UTC

FDA will require a new boxed warning label for Type II diabetes drug canagliflozin from Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) and Johnson & Johnson (NYSE:JNJ), noting increased risk of leg and foot amputations. The warning was prompted by final results from the Phase III CANVAS and Phase IV CANVAS-R trials which showed that amputations occurred about twice as often in patients treated with canagliflozin compared to patients who received placebo.

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