Johnson & Johnson is required so as to add new warnings to its diabetes drug, Invokana, concerning the danger of foot and leg amputations, the US Meals and Drug Administration stated on Tuesday.
Ultimate outcomes from two medical trials confirmed leg and foot amputations occurred about twice as typically in sufferers with sort 2 diabetes handled with Invokana, recognized additionally as canagliflozin, as these given a placebo, the FDA stated in an announcement posted on its web site.
The warnings embrace a boxed warning, reserved for probably the most critical potential antagonistic occasions, the FDA stated.
Invokana belongs to a comparatively new class of sort 2 diabetes medicine referred to as SGLT-2 inhibitors, which assist take away extra blood sugar by means of urine. Others in the identical class embrace Eli Lilly and Co’s Jardiance and AstraZeneca Plc’s Farxiga.
The FDA famous that outcomes of 1 medical trial confirmed that over the course of a yr the danger of amputation in sufferers handled with Invokana was equal to five.9 out of 1,000, in contrast with 2.eight out of 1,000 for sufferers given a placebo.
A second trial confirmed the danger of amputation was equal to 7.5 out of each 1,000 sufferers handled with Invokana, in contrast with four.2 out of each 1,000 sufferers given a placebo.
The company stated amputations of the toe and center of the foot have been the most typical however that amputations involving the leg, under and above the knee, additionally occurred.
Untreated sort 2 diabetes may cause blindness, nerve and kidney injury, and coronary heart illness.
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