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The diabetes drug canagliflozin (Invokana, Invokamet, Invokamet XR) will no longer carry a boxed warning label regarding lower limb amputation risk, the FDA announced Wednesday.

After a review of new clinical data, the agency , instead placing information on amputation risk further down in the section of the prescribing information.

First approved in 2013, the SGLT-2 inhibitor had the warning added to its label in 2017 based on findings of the . While findings in these studies also documented cardioprotective properties for canagliflozin, they also showed that rates of lower limb amputation were doubled with the drug versus placebo (5.9 vs 2.8 per 1,000).

Another CANVAS study designed to examine renal effects also found higher amputation rates with canagliflozin relative to placebo (7.5 vs 4.2 per 1,000).

But after a review of new data from trials demonstrating additional heart- and kidney-related benefits of canagliflozin, the FDA determined that amputation risk -- while still increased -- is lower than previously thought.

"Collectively, these newly identified effects of canagliflozin on heart and kidney disease show significantly enhanced benefit of this medicine," the FDA explained in a statement, thus tilting the benefit-risk balance more in the drug's favor.

Based on the CANVAS program, canagliflozin gained an additional indication in October 2018 for the prevention of myocardial infarction, stroke, and death among patients with type 2 diabetes who have established cardiovascular disease.

In September 2019, canagliflozin received another label expansion: prevention of end-stage kidney disease, worsening renal impairment, cardiovascular death, hospitalization for heart failure, and diabetic nephropathy with albuminuria in adults with type 2 diabetes and diabetic kidney disease based on the CREDENCE study, which found no increased risk for amputation.

In its Wednesday statement, the FDA recommended patients on canagliflozin should receive preventive foot care and be monitored for new pain, tenderness, sores, ulcers, and infections in the legs and feet. The FDA also suggested prescribers weigh a patient's risk for amputation when selecting antidiabetic medicines.

Canagliflozin is not indicated for people with type 1 diabetes or those on dialysis.

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