May 16, 2017 — The FDA will require a Black Box warning label about the risk of leg and foot amputations from the diabetes drugs Invokana, Invokamet, or Invokamet XR (canagliflozin).
Final results from two large clinical trials — CANVAS and CANVAS-R — showed that leg and foot amputations were twice as likely to occur in patients who took canagliflozin compared to a placebo.
The FDA issued a warning in May 2016 based on preliminary results that showed 7 out of 1,000 patients on 100-mg/day canagliflozin required an amputation, vs. 3 out of 1,000 patients on a placebo.
Amputations of the toe and middle foot were most common, but amputations of the leg below and above the knee also occurred. Some patients had multiple amputations, or both legs amputated.
Patients on Invokana, Invokamet, or Invokamet XR should tell their doctor right away if they develop symptoms of diabetic foot disease, such as pain, tenderness, sores, ulcers, or infections. The risk-factors may include a history of diabetic foot disease, amputations, peripheral vascular disease, and diabetic foot ulcers.
Invokana (canagliflozin) treats type-2 diabetes by forcing the kidneys to remove more sugar from the body in urine. One of the most common side effects is dehydration due to excessive urination, which can deplete blood-volume and cause circulation problems in the feet.
Diabetics have a high risk of amputations for a few reasons. Over time, high blood-sugar causes blood vessels to narrow and harden, which decreases circulation to the toes. This can cause tissue death (necrosis), nerve damage that makes it hard to feel injuries, and slow healing. Infections are hard to control and often require amputation.
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