INVOKANA, INVOKAMET, INVOKAMET XR

INCREASED RISK OF LEG AND FOOT AMPUTATIONS

Canagliflozin is a prescription drug that is used to lower blood sugar levels in adults with Type 2 diabetes.  It can be prescribed as a single-ingredient product (canagliflozin only) called Invokana, or a combination-ingredient product (canagliflozin and metformin) called Invokamet and Invokamet XR.   Invokana is in a class of drugs called SGLT2 Inhibitors which reduce blood sugar levels by triggering the kidneys to removing small amounts of sugar through the process of urination.  

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In May of 2017, the FDA reported that preliminary results of two large clinical trials showed an increased risk of amputations when patients were taking canagliflozin (Invokana, Invokamet or Invokamet XR).   In July of 2017, the final report on these 2 clinical trials resulted in the FDA confirming the increased risk of leg and foot amputations when taking canagliflozin medications (Invokana, Invokamet or Invokamet XR) and requiring that a BOXED WARNING, the most prominent warning required by the FDA to be added to the canagliflozin drug labels.  

Below is an excerpt from the FDA which details these unfortunate findings:

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 that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. The CANVAS trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:

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

The CANVAS-R trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:

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

Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.

 

Carey Danis & Lowe is investigating the allegations that Johnson & Johnson, the manufacturer of Invokana, were negligent in:

  • properly testing this medication
  • warning physicians and the public of the great risk of below-the-knee amputations  
  • concealing evidence of these risk from the FDA and the public
  • misrepresenting how safe the medication was in their written and online marketing materials

LINKS:  

July 2017:  FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)

https://www.fda.gov/drugs/drugsafety/ucm557507.htm

May 17:  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

https://www.fda.gov/Drugs/DrugSafety/ucm500965.htm

FDA Facts about Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors   https://www.fda.gov/Drugs/DrugSafety/ucm475463.htm

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