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FDA Warns of Increased Risk of Invokana Leg and Foot Amputations

Washington, DC: The US Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet).

The agency has not determined whether canagliflozin increases the risk of leg and foot amputations, but are currently investigating this new safety issue.

Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

In the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) clinical trial, the trial' independent data monitoring committee (IDMC) identified an increased risk of leg and foot amputations.

The amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. An interim analysis showed that over a year' time, the risks of amputation for patients in the trial were equivalent to:

7 out of every 1,000 patients treated with 100 mg daily of canagliflozin

5 out of every 1,000 patients treated with 300 mg daily of canagliflozin

3 out of every 1,000 patients treated with placebo

Patients in the CANVAS trial have been followed for an average of 4.5 years to date. The IDMC has recommended, based on an overall assessment, that the CANVAS trial continue.

The IDMC has also reported that a second, similar trial evaluating canagliflozin, the CANVAS-R trial, has not shown the same risks of increased leg and foot amputations to date. Patients in the CANVAS-R trial have been followed for an average of 9 months.


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