The U.S. Food & Drug Administration (FDA) has announced that a new boxed warning regarding an increased risk for leg and foot amputations will be added to the labeling of the type 2 diabetes medications Invokana (canagliflozin) and Invokamet (canagliflozin and metformin).
Free Confidential Lawsuit Evaluation: If you or a loved one was forced to undergo an amputation after taking Invokana or Invokamet, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the Problem?
May 16, 2017 – The new warnings follow a May 2016 FDA Safety Alert that was based on interim data from one of two trials in which the amputation risk was seen in one but not the other.
Now, final results from both trials — the CANVAS and CANVAS-R studies — indicate an approximate doubled risk for both leg and foot amputations in patients treated with canagliflozin compared to those who took a 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.
The European Medicines Agency (EMA) has been investigating the amputation risk with canagliflozin since April 2016, and in February 2017 required that labeling of all type 2 diabetes drugs from the sodium glucose cotransporter 2 (SGLT2) inhibitor class carry an amputation warning.
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 Class Action Lawsuit?
The Class Action 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 injured by the side effects of Invokana or Invokamet, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.