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Invokana/Canagliflozin Receives FDA Black Box Warning Due to Risk of Foot and Leg Amputation


Invokana Amputation Lawyer - Invokana Recall Lawyer - Canagliflozin Recall Lawyer

The US Food and Drug Administration (FDA) just added a black box warning to the labels of prescription medications containing canagliflozin, a drug used to treat type 2 diabetes, after data from not one but two significant clinical trials revealed an increase in the risk of foot and leg amputations among patients.

If you or a loved one have been forced to undergo a leg or foot amputation while taking Invokana (canagliflozin) for type 2 diabetes, contact our Undefeated Drug Recall Lawyers for a free consultation by clicking here or calling 1-888-603-3636.

The drug, sold under the names Invokana, Invokamet and Invokamet XR by Janssen Pharmaceuticals, Inc., was in fact found to be responsible for doubling the rate of foot and leg amputations in users versus those diabetic patients treated with a placebo.

This latest announcement is an update to an earlier communication issued in May of 2016 warning of problems with the drug.

What Sparked the FDA’s Concerns Regarding the Safety of Canagliflozin?

The clinical trials referenced include CANVAS (Canagliflozin Cardiovascular Assessment Study; identifier NCT01032629) and CANVAS-R (A Study of the Effects of Canagliflozin [JNJ-28431754] on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus; identifier NCT01989754).

Over the course of a single year, the risk of amputation for patients in CANVAS and CANVAS-R was found to be 5.9 and 7.5 out of every 1000 patients treated with canagliflozin versus 2.8 and 4.2 out of every 1000 patients treated with the placebo.

According to the FDA, amputations of the toe and middle of the foot were most commonly linked with canagliflozin use, although above-the-knee and below-the-knee leg amputations were reported also.

What’s Being Done to Solve the Problem?

In an effort to inform patients of the increased risk of foot and leg amputations, the FDA has elected to require a new boxed warning.

Unfortunately, the drug remains on the market at this time.

Patients and health care professionals are being asked to report any adverse effects stemming from the use of canagliflozin to the FDA MedWatch program