INVOKANA, INVOKAMET, INVOKAMET XR

INCREASED RISK OF LEG AND FOOT AMPUTATIONS

FDA reports link the popular diabetes drug, Invokana®, to a number of severe health complications. Many are taking action against the drug’s manufacturer for failing to properly warn consumers about the life-threatening side effects.

If you were prescribed Invokana®, Invokamet®, or Invokamet XR® and you suffered a serious side effect, you may be entitled to compensation for your injury. The drug company should be held responsible for your resulting medical bills, missed income, and other losses. Contact our Invokana® lawsuit lawyers for a free case consultation today.

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What is Invokana®?

Canagliflozinis 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.

It quickly became a leading choice since 2013 for those who suffer from type 2 diabetes.

Invokana® Side Effects & Complications

Drug manufacturers marketed Invokana® as an advanced alternative to existing type 2 diabetes medications. Unfortunately, this drug is not all that patients were led to believe. Varying serious consequences have occurred after taking Invokana®, Invokamet®, and Invokamet XR®.

  • Invokana® Complications
  • Leg, foot, and toe amputations
  • Kidney damage
  • Ketoacidosis
  • Infections
  • Heart attacks
  • Stroke
  • Bone fractures

Johnson & Johnson and its Janssen Pharmaceuticals unit did not properly warn physicians and patients of the potential risks associated with the drug. If consumers were made aware, they might have opted to take a different drug or would have more closely monitored their health. Instead, countless people have suffered at the hands of the manufacturer’s negligence.

FDA Finds Evidence of Adverse Effects in Patients

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 theFDA 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:

Two clinical trials were conducted: 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).

The final results showed that leg and foot amputations occurred about twice as often in patients that were 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. Amputations involving the leg—below and above the knee—also occurred. In some cases, people had more than one amputation, a number of them involving both limbs.

Invokana® Lawsuit Lawyers

The experienced lawyers at Carey Danis & Lowe are 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

If you or a loved one have suffered a serious health complication after taking Canagliflozin medications such as Invokana®, Invokamet®, or Invokamet XR®, contact us for a free consultation. Our lawyers are ready to fight big drug companies to get you what you’re entitled.

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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