J&J directed to add new warnings to diabetes drug Invokana

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Johnson & Johnson's type 2 diabetes medicine Invokana (canagliflozin) will now be required to carry a black box warning for an increased risk of foot and leg amputations, the Food and Drug Administration said Tuesday in a safety alert posted to its website. A boxed warning will be added to canagliflozin drug labels to describe the risk.

Final results from two clinical trials-the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type-2 Diabetes Mellitus) studies-showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo. Before prescribing canagliflozin, FDA advises health care professionals to consider factors that may predispose patients to the need for amputations, including a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.

Most of the amputations were of toes or the middle of the foot, but some patients needed their entire foot or leg removed, sometimes even above the knee. In the other, which enrolled 5,814 patients, 7.5 out of 1,000 patients receiving canagliflozin had a foot or leg amputation that year, compared to 4.2 out of 1,000 of the patients receiving a placebo.

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The FDA recently issued a safety communication regarding canagliflozin (Invokana, Invokamet, Invokamet XR) due to an elevated risk of serious adverse events. This warning is an update to the safety communication issued on May 18, 2016. "Jardiance likely will be a near-term beneficiary of further and perhaps accelerated market share losses for Invokana", Leerink Partners analyst Seamus Fernandez wrote in a note to clients. Invokana and Jardiance belong to a class of drugs called SGLT2 inhibitors. The Canvas-R trial began in October 2013.

Now, though, "the increasingly differentiated labels and data to date suggest that ..." After all, SGLT2 rival Jardiance from Eli Lilly and Boehringer Ingelheim has already showed it can cut the combined rate of heart attack, stroke and cardiovascular death in high-risk Type 2 patients, and J&J is crossing its fingers that its med can do the same in an upcoming trial.

But the increased risk of lower limb amputation has heightened in recent years.