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FDA Confirms Amputation Risk with Invokana, Invokamet

The FDA has concluded that patients who take Invokana and Invokamet for the treatment of type 2 diabetes face an increased risk of leg and foot amputations.

The U.S. Food & Drug Administration (FDA) has concluded that patients who take Invokana (canagliflozin) and Invokamet (canagliflozin / metformin) for the treatment of type 2 diabetes face an increased risk of leg and foot amputations.

Free Confidential Lawsuit Evaluation: If you or a loved one had an amputation after taking Invokana or Invokamet, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.

What’s the problem?

May 16, 2017 – Based on data from 2 large clinical trials — the CANVAS and CANVAS-R studies — FDA is requiring that labels of Invokana and Invokamet be updated with a boxed warning about an increased risk of amputations associated with use of the drugs.

Final results from CANVAS and CANVAS-R indicated that patients treated with canagliflozin were about twice as likely to have a foot or leg amputation compared to those who received a placebo. Specifically, CANVAS found that over a year’s time, the amputation risk was equivalent to:

  • 5.9 out of every 1,000 patients treated with canagliflozin
  • 2.8 out of every 1,000 patients treated with placebo

Over the same time period, CANVAS-R found the risk to be:

  • 7.5 out of every 1,000 patients treated with canagliflozin
  • 4.2 out of every 1,000 patients treated with placebo

Amputations most commonly associated with Invokana and Invokamet occurred in the toe and middle of foot, but some also involved the leg (below and above the knee). Some patients were forced to undergo more than one amputation, and some of those involved both limbs.

Patients who take Invokana or Invokamet should contact their healthcare provider immediately if they develop any new pain or tenderness, sores or ulcers, or infections in their legs or feet. However, FDA cautions that patients should never stop taking their diabetes medications without talking to their doctor first.

Do I Have an Invokana Lawsuit?

The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Invokana lawsuits. We are handling individual litigation nationwide and currently accepting new amputation cases in all 50 states.

Free Case Evaluation: Again, if you were harmed by the side effects of Invokana, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

Free Confidential Case Evaluation

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