FDA removes amputation Boxed Warning from canagliflozin label
medwireNews: The FDA has removed the Boxed Warning about increased amputation risk from the canagliflozin label.
The warning was added in 2017 following the results of the CANVAS trials, when canagliflozin was approved purely as a glucose-lowering medication.
Since then, however, its indication has expanded to include cardiovascular risk reduction in people with diabetes and existing heart disease, and most recently renoprotection in those with chronic kidney disease, based on the CREDENCE findings.
“Collectively, these newly identified effects of canagliflozin on heart and kidney disease show significantly enhanced benefit of this medicine,” says the FDA.
“Safety information from recent clinical trials also suggests that the risk of amputation, while still increased with canagliflozin, is lower than previously described, particularly when appropriately monitored. Based upon these considerations, we have concluded that the Boxed Warning should be removed.”
But the FDA stresses that amputation remains a risk and healthcare professionals should carefully monitor people with type 2 diabetes for pain, sores, ulcers, and infections in the legs and feet.
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