FDA Warning: Invokana Foot and Toe Amputations

May 18, 2016 — The FDA has issued a Safety Communication to warn about the risk of amputations from the diabetes drug Invokana (canagliflozin).

The warning was issued after preliminary data from the CANVAS clinical trial found an increased risk of leg and foot amputations — mostly toe amputations — in patients treated with Invokana.

The analysis found that 7 out of ever 1,000 patients treated with 100-mg daily doses of Invokana had toe amputations — more than twice as often as patients on a placebo.

In comparison, amputations occurred in 3 in 1,000 patients on a placebo and 5 in 1,000 on the 300-mg dose.

The European Medicines Agency (EMA) issued a similar warning last month. However, both agencies have not determined whether Invokana actually increases the risk of amputations. In the meantime, the FDA recommends:

“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.”

Doctors should remind patients about the importance of treating foot injuries promptly and avoiding cuts or sores that could lead to an infection.

Experts are not sure why Invokana is associated with a higher risk of amputations. It treats diabetes by forcing the kidneys to remove extra sugar in urine, which can cause dehydration and low blood pressure. This could decrease circulation to the feet, which is a common problem in people with type-2 diabetes.

The new warnings add to a growing list of severe side effects linked to Invokana. The FDA has also issued warnings about ketoacidosis, infections, kidney failure, bone fractures, and more.

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