May 18, 2016 — Invokana has been associated with a doubled increased risk of leg and foot amputations in an ongoing clinical trial, according to the FDA.
The FDA issued a Safety Communication after preliminary data from the CANVAS clinical trial found that 7 in 1,000 patients on Invokana (100-mg/day) had amputations, compared to 3 in 1,000 on a placebo.
The agency is not yet sure whether Invokana actually increases the risk of amputations. But in the meantime, patients should be vigilant for foot complications and seek treatment as soon as possible:
“Patients taking canaglifozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.”
Experts are not sure why Invokana was associated with a higher risk of foot amputations. It works by increasing urination, which can lead to dehydration, low blood pressure, and poor circulation in the feet.
Foot complications are very common in people with type-2 diabetes. Even minor cuts or sores can become infected and require amputation.
The new warnings add to a long list of severe side effects the FDA has linked to Invokana since it was approved in 2013. Those risks include ketoacidosis, infections, kidney failure, bone fractures, and more.
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The Schmidt Firm, PLLC is currently accepting Invokana induced injury cases in all 50 states. If you or somebody you know needed an amputation, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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