Diabetes Drug Invokana Linked to Leg and Toe Amputations

Invokana is the first in a new class of type 2 diabetes drugs, first approved by the FDA in 2013. Even with this approval, the drug is still new by drug standards and carries considerable risks.  It is questionable if it should have been fast tracked through FDA approval as complication warnings are being added at a rapid rate. The most recent is the increased risk of amputation for Invokana and Invokamet users. Clinical trials showed patients had an increase in urinary tract and yeast infections, and dizziness. The FDA does not recommend Invokana be used by patients with severe kidney problems, those on dialysis, or patients with increased ketones in the blood or urine. Long-term studies have been ordered as well.

In May of 2017, the FDA reported a link between Invokana or Invokamet and leg, foot and toe amputations.

“ISSUE: Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.”

May 2016 – FDA warns of increased risk in clinical trials between Invokana and leg, foot and toe amputations.

In May 2015, the FDA reported a link between Invokana and “too much acid in the blood” or diabetic ketoacidosis.

Patients who suffered major complications from Invokana may be eligible for a cash reward settlement.

Serious Complications Associated with Invokana

Manufacturers Johnson & Johnson and Janssen Pharmaceuticals claim Invokana is safe and effective, although a number of side effects have been associated with their drug. The following side effects have been reported:

  • Kidney impairment
  • Kidney stones
  • Urinary tract infections (UTIs)
  • Yeast infections
  • Weakness or Dizziness
  • Dehydration
  • Allergic Reactions

 

In addition to the side effects that are known from clinical trials, Invokana may also be linked to very serious health conditions: Leg and Foot Amputation, Kidney Failure and Diabetic Ketoacidosis.

Diabetic Ketoacidosis occurs when their is too much acid in the blood. Ketoacidosis most frequently occurs in type 1 diabetes patients, in cases where insulin levels are very low or due to fasting; this condition is rare in type 2 patients. FDA reported cases of ketoacidosis in Invokana patients have required hospitalization or emergency treatment. Symptoms of ketoacidosis include:

  • Trouble breathing
  • Abdominal pain
  • Nausea and/or vomiting
  • Confusion
  • Fatigue or sleepiness

 

If any of these symptoms are observed, patients should seek immediate medical attention. If left untreated, ketoacidosis can lead to diabetic coma or death.

Invokana Lawsuit Information

It is believed that the manufacturer withheld, or failed to adequately find and report, all health risks associated with their product.

Invokana (generic name “canagliflozin”) is a once daily pill prescribed to help type 2 diabetes patients control blood sugar levels. Invokana is the first in a new class of diabetes drugs and has only been on the market for a few years. This drug class, called sodium-glucose cotransporter-2 (SGLT2) inhibitors, help lower high blood sugar, but also affect kidney function by blocking glucose absorption in the blood and increasing glucose excretion in the urine. This is a distinct mechanism when compared to every other diabetes drug on the market.

With more than 10% of the adult population consisting of diabetics, and more than 1/3 of adults in America at risk for developing type 2 diabetes, first-in-class drugs like Invokana are poised to make major profits for their manufacturers. It is predicted that Invokana will make well over 400 billion dollars in sales by 2017.

Invokana was aggressively marketed and may have been under studied for safety. It is believed that the manufacturer withheld, or failed to adequately find and report, all health risks associated with their product.

If you or a loved one took Invokana and experienced toe, leg or foot amputation or amputations, kidney failure, diabetic ketoacidosis, or wrongful death, you may be entitled to a cash reward settlement. Contact us for a free, no obligation case review.

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