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FDA Adds ‘Black Box’ Label for Invokana Amputation Risk

May 16, 2017 — The diabetes drugs Invokana and Invokamet will now carry a “Black Box” warning that they double a patient’s risk of leg and foot amputations.

The FDA required its strongest warning label after reviewing final results from the CANVAS and CANVAS-R clinical trials.

The agency issued a preliminary warning in May 2016 after the studies showed that 7 out of 1,000 patients on canagliflozin required an amputation, vs. 3 out of 1,000 patients on a placebo. According to the most recent Safety Announcement:

“Amputations to the toe and middle of the foot were the most common, however, amputations involving the leg, below and above the knee also occurred. Some patients had more than one amputation, some involving both limbs.”

Patients on Invokana, Invokamet, or Invokamet XR should tell their doctor right away if they develop new foot pain or tenderness, sores, ulcers, infections, or other symptoms of diabetic foot disease.

The risk of amputations increases for patients who have a history of amputations, foot disease, peripheral vascular disease, or foot ulcers.

Invokana (canagliflozin) is a prescription medication for type-2 diabetes that reduces blood-sugar levels by forcing the kidneys to remove more sugar from the body in urine. Excessive urination can cause dehydration, low blood-volume, and circulation problems.

Over time, high blood-sugar causes blood vessels to narrow and harden. This causes poor circulation in the toes, tissue death (necrosis), and nerve damage that makes it hard to feel when foot injuries occur. These injuries heal slowly and easily become infected. Amputations are often necessary to control the spread of infections.

Do I have an Invokana Lawsuit?

The Schmidt Firm, PLLC is currently accepting Invokana induced injury cases in all 50 states. If you or somebody you know had a foot or leg 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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