Invokana Drug Lawsuit Source

Invokana Complications: Foot and Leg Amputation

Commonly asked questions about Invokana and its link to foot and leg amputation:

Can Invokana Cause You To Have To Get Your Foot or Leg Amputated?

The U.S. Food and Drug Administration recently issued a safety alert that the diabetes drug canagliflozin (Invokana) has been associated with an increase in leg and foot amputations — largely affecting the toes.

The FDA is reportedly investigating the safety issue, but has yet to determine if taking canagliflozin (Invokana) is associated with an increased risk of leg and foot amputations.

The safety alert was issued nearly two weeks after the European Medicines Agency (EMA) announced that it was conducting an investigation into reports of lower limb amputations.

The FDA and EMA both approved Invokana in 2013 as a treatment for type 2 diabetes.

Does Invokana Increase The Risk of Having To Get A Foot or Leg Amputated?

The FDA’s safety communication comes after a four-year interim analysis, completed by the independent monitoring committee for the Canagliflozin Cardiovascular Assessment Study (CANVAS).

The study tracked roughly 4,000 type 2 diabetes patients treated with either a 100 mg or 300 mg daily dose of Invokana or a placebo. The panel reportedly found there were higher rates of lower-limb amputation in the Invokana groups.

On May 16, 2017, the FDA put out a safety announcement confirming an increased risk of leg and foot amputations with the SGLT2 inhibitor canagliflozin (Invokana, Invokamet).

“Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk,” the warning says.

“Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.”

What Kind of Foot Complications Can I Develop?

People with diabetes can develop many different foot problems.

Foot problems most often happen when there is nerve damage, also called neuropathy. Neuropathy can cause tingling, pain (burning or stinging), or weakness in the foot, according to the American Diabetes Association.

Below is a list of a half-dozen foot complications often caused by type 2 diabetes.

  1. Neuropathy
  2. Skin changes
  3. Calluses
  4. Foot ulcers
  5. Poor circulation
  6. Amputation

What Can I Do to Reduce Foot and Leg Complications?

According to the Mayo Clinic, the best strategy for preventing complications of diabetes is proper diabetes management with a healthy diet, regular exercise, blood sugar monitoring and adherence to a prescribed medication regimen.

Proper foot care will help prevent problems with feet and ensure prompt medical care when problems occur. The following is a list of 10 tips for preventing foot complications due to diabetes, according to the Mayo Clinic:

  1. Inspect your feet daily
  2. Wash your feet daily
  3. Don’t remove calluses or other foot lesions yourself
  4. Trim your toenails carefully
  5. Don’t go barefoot
  6. Wear clean, dry socks
  7. Buy shoes that fit properly
  8. Don’t smoke
  9. Schedule regular foot checkups
  10. Take foot injuries seriously

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Can I File An Invokana Foot and Leg Amputation Lawsuit?

The FDA is conducting an ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) clinical trial, the trial’s independent data monitoring committee (IDMC) identified an increased risk of leg and foot amputations. The study says that the amputations occurred about twice as often in patients treated with canagliflozin (Invokana) compared to patients treated with placebo, which is an inactive treatment.

How Many Invokana Foot/Leg Amputations Have Been Filed?

There are currently several dozen product liability lawsuits that are pending nationwide. However Invokana lawsuit lawyers are continuing to review and file cases for individuals who have experienced problems. It is expected that potentially thousands of claims will be brought against the manufacturers over their new diabetes drug.

What Are The Serious Side Effects Of Invokana?

There are a number of serious side effects that can occur from the use of Invokana, these side effects include:

What Are The Less Serious Side Effects Of Invokana?

There are also a number of other less serious side effects associated with the use of Invokana, these side effects include:

  • Urinary Tract Infections
  • Increased urination
  • Yeast Infections
  • Thirst
  • Constipation
  • Nausea
  • Fatigue
  • Weakness
  • Skin sensitivity to sunlight
  • Hypersensitivity reactions

What are the Criteria for Filing an Invokana Lawsuit?

Approved in March 2013, Invokana (canagliflozin) is an SGLT2 Inhibitor used to treat adults with Type 2 diabetes, manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

SGLT2 inhibitors work by preventing high blood sugar by helping the patient’s kidneys remove excess sugar through their urine.

In May 2015, the U.S. Food and Drug Administration (FDA) issued a warning the drug has been linked to cases of ketoacidosis, a serious condition where there is too much acid in the blood.

Complications of diabetic ketoacidosis include difficulty breathing, nausea/vomiting, abdominal pain, confusion and unusual fatigue or sleepiness. The condition can lead to diabetic coma and/or death.

The national Invokana lawsuit alleges that the manufacturers and marketers of SGLT2 Inhibitors failed to warn patients and physicians of the increased risks of kidney failure, myocardial infarction (heart attacks), other cardiovascular issues, and ketoacidosis.

The lawsuit states that if the manufacturers and marketers had properly warned of the risks, patients would have been prescribed and taken a substitute medication for their diabetes and would have had their health monitored on a more routine basis for potential signs of heart issues, renal impairment, and high level of ketones.

If you suffered severe complications from taking an SGLT2 Inhibitor, you may be entitled to compensation. Below is the criteria required to file an SGLT2 Inhibitor lawsuit:

  • Patient has taken Invokana, Invokamet, Farxiga, Glyxambi, Jardiance, or Xigduo XR and suffered one or more of the following:
    • Kidney failure
    • Diabetic Ketoacidosis
    • Heart attack
    • Stroke
    • Death
    • Dehydration requiring hospitalization
    • Bone fracture
    • Amputation

Our Invokana Foot and Leg Amputation Case Lawyers Can Help You

Our dangerous drug attorneys can help if you or someone you care about was harmed by Invokana.

Lawsuits have been filed against the drug manufacturers by both patients and their families seeking compensation for injuries caused. You may be entitled to a settlement.

We do not charge any legal fees unless you receive a settlement and we pay all of the case costs. If your claim is not successful for any reason, you do not owe us anything. We put it all in writing for you. Our lawyers will help you file your lawsuit.

Our No-Fee Promise on Invokana Foot and Leg Amputation Cases

You can afford to have our great team of lawyers on your side. When you choose us, it literally costs nothing to get started. We promise you in writing:

  • No money to get started
  • We pay all case costs and expenses
  • No legal fees whatsoever unless you receive a settlement
  • Phone calls are always free.

Start Your Invokana Foot and Leg Amputation Claim

Our Invokana foot and leg amputation case lawyers will help you file your lawsuit. To get started, you can:

  1. Submit the Free Case Review Box on this page, or
  2. Call (866) 280-3417 any time of day to tell us about your case.

We will listen to your story and answer your questions. If you have claim, we will start immediately.

WARNING: There are strict time deadlines for filing Invokana foot and toe amputation lawsuit claims.

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View Sources

  1. Diabetic Complications and Amputation Prevention – Foot Health Facts
  2. Amputation and Diabetes: How to Protect Your Feet – Mayo Clinic
  3. How to Avoid Amputations if You Have Diabetes – Health.com

References

  • Number (in millions) of civilian, non-institutionalized persons with diagnosed diabetes, United States, 1980–2011. CDC Data Sheet.
  • American Diabetes Association Standards of medical care in diabetes—2013. Diabetes Care36. S11–S66.