FDA Says Invokana (Canagliflozin) Causes Increased Risk of Leg, Foot Amputations

Francis Osborne
May 18, 2017

Based on two recent studies, the U.S. Food and Drug Administration (FDA) has issued a warning against type 2 diabetes medicine canagliflozin, sold commercially as Invokana, Invokamet, and Invokamet XR.

The FDA's decision follows a MedWatch safety alert from this time past year, which regulators issued after finding that patients in the Invokana arms of J&J's two cardiovascular outcomes studies for the med were about twice as likely to experience amputations than were those in the placebo groups.

Invokana's label also includes a warning for acute kidney injury, which was added last summer after more than 100 confirmable reports of kidney injury from treatment with Invokana or AstraZeneca's Farxiga (dapagliflozin) were reported to the FDA between March 2013 and October 2015. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors.

FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate. Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. In one, which had 4,330 patients enrolled, 5.9 out of 1,000 patients treated with the drug needed amputations, compared to 2.8 out of 1,000 patients receiving a placebo.

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The amputations were most commonly of the toe and middle of the foot, though some involved the leg, below and above the knee. In some cases, both limbs had to undergo amputation.

"Final results from two clinical trials - the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) - showed". Amputations of the leg, below and above the knee also happened and some patients required more than one amputation.

If you are taking canagliflozin, you should notify your doctor right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Even if ulcers are present, the patient should not stop taking the drug unless a physician indicates otherwise. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.

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