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Invokana

Prescription Drug Lawsuit

Invokana Amputation Victims

By | Invokana, Personal Injury Attorneys | No Comments

Invokana® Amputation Lawsuit

The FDA is requiring new warnings to be added to the diabetic drug Invokana to explain and emphasize the risk of amputations associated with Invokana use.  As a result physicians are taking action against using Invokana this according to a recent article by Inewsource, with some physicians taking their patients off of Invokana. The prescribing habits of physicians apparently changed after the FDA required the manufacturer, Johnson & Johnson, of Invokana to place a Black Box warning about the doubling of the risk of limb amputation with use of the drug. The most common amputations are toe, foot and lower leg. Invokana is prescribed to people with Type II diabetes.

Patients are urged to contact their doctor if they notice pain, tenderness, sores, ulcers or infections in their limbs. However, patients should not stop using this drug without consulting the doctor that prescribed Invokana.

Many physicians still prescribe Invokana believing that the drug is beneficial to patients. It is estimated that 4.5 million Invokana prescriptions were filled in the United States in 2016, so many patients could be affected by use of this drug.

Other Complications Associated With Invokana

The study that shined a bright light on the serious risk of amputations associated with Invokana also raised the questions about a condition called diabetic ketoacidosis. Other drugs in the same class of medication as Invokana carry a warning about ketoacidosis.

Cardiac risk is also a concern with Invokana. One of the investigators on the Invokana Clinical trial questioned the methods that were used to say that the drug prevented major cardiac events this according the Inewsource article.

We Can Help

If you or loved one has suffered a limb amputation while using Invokana you may have many questions about whether you have a claim against the manufacturer of Invokana. The James Esparza Law Firm can answer your questions. We have helped thousands of individuals and families recover from life altering injuries. We would like to help your too. Call us now at 1-800-745-4050. We will help you obtain full and complete compensation.

Helpful Links.
Doctors debate danger of popular diabetes drug after FDA amputation warning

Invokana Amputation; Heart Attacks

Invokana Black Box Warning – Leg & Foot Amputations

By | Invokana | No Comments

INVOKANA® BLACK BOX WARNING LEG, TOE & FOOT AMPUTATIONS

The Food & Drug Administration (FDA) is requiring a black box warning to appear for Invokana® and Invokamet® alerting users and physicians of the serious adverse event of an increased risk of Leg, Toes & Foot Amputations with Invokana use.  Black box warnings are reserved for the most serious adverse events.

Doubling of the Risk of Leg & Foot Amputations

Invokana® is manufactured by Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson. The FDA warning is the result of two large clinical studies that found that Invokana users faced twice the risk of leg and foot amputations with Invokana® compared to placebo users.  The studies were CANVAS (Canagliflozin Cardiovasculare Assessment Study) and CANVAS-R.

According to the FDA, the CANVAS trial showed that over a 1 year period that the risk of amputation was

  •  5.9 out of every 1000 patients treated with Invokana®
  • 2.9 out of every 1000 patients treated with placebo

CANVAS R results showed that over a 1 year period that the risk of amputation was

  • 7.5 out out every 1000 patients treated with Invokana®
  • 4.2 out of every 1000 patients treated with placebo

This is not the first time the FDA has expressed concern over Inovkana®.  In May 2016 the FDA’s review of interim clinical data caused the FDA to further investigate the increased risk of lower limb amputations, mostly toes, with the diabetes medicine Invokana®

The most common type of amputations was of the toe and middle of the foot. Amputations involving the leg, below and above the knee, had occurred as well. In addition, some patients had more than one amputation, some of which involved both limbs.

The FDA warning provides further information about Invokana® in regard to its usage, methodology, and side effects. It’s a prescription medicine used primarily with diet and exercise in order to lower the level of blood sugar in adults with type 2 diabetes. It falls into the drug class of sodium-glucose cotransporter-2 (SGLT2) inhibitors. It reduces the blood sugar by triggering the kidneys to remove sugar in the body through urine.

The FDA recommends “patients taking Invokana® 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.” This recommendation is further supplemented by emphasizing one shouldn’t stop their diabetes medication without first consulting their health care professional.

We Can Help You.

If you or a loved one has taken Invokana® and sustained an amputation of the foot, toes or leg we would like to help you.  Call for a confidential consultation at 1-800-745-4050.

Helpful link:

FDA

 

 

Invokana Kidney Injuries – We Can Help

By | Invokana | No Comments
Invokana Kidney & Heart Attacks

Invokana Kidney Injury

Invokana® Lawsuit News!

A Invokana kidney injury case can proceed according to a federal judge. No preemption exists according to Judge Martin Feldman. The case concerns the plaintiff developing acute kidney damage while using Invokana a Janssen Pharamaceutical product. Janseen is a division of Johnson & Johnson.

The case involved Gloria Guidry who was prescribed Invokana to treat her Type II diabetes.  She took Invokana from approximately 6 months before she was hospitalized for acute kidney injury and acute kidney failure. Guidry alleged that Invokana caused her acute kidney failure.

In the Guidry, Janssen filed a motion to dismiss urging Judge Feldman to dismiss all of the plaintiff’s claims because of preemption.  The were many issues addressed in Judge Feldman’s 45 page opinion.  However, the key issue in the case was whether a defective design claim arising from use of a brand name prescription drug, Invokana®, is preempted.

Judge Feldman ruled that under Louisiana law that a defective design claim against a brand name prescription drug is not preempted. His rational seemed to be focus, in part, on providing Louisiana residents the right to go to court and have their claim heard by a jury.  Further, a key fact the plaintiff alleged was that Janssen knew Invokana’s design posed an unreasonably dangerous risk of kidney injury before it was approved by the FDA.

How Does Invokana Work?

As noted in our Current Investigations, Invokana is designed to help diabetics reduce excess blood sugar by blocking re-absorption of glucose in the kidneys.  Instead glucose is pushed out through urination.  In this process, it is alleged, sugar builds up in the tubes connecting the kidney to the bladder, forcing the kidneys to over work.  This causes the kidneys to stress leading to kidney injury and kidney failure.

Why You Should Select Us?

If you have a serious injury case you need an experienced product liability attorney.  At the James Esparza Law Group we only accept clients who have been harmed from defective products. We provide each client with the personal care and attention they deserve.  If you or a loved one would like to discuss your Invokana injury we are here to answer your questions. We will make no promises to you, but we will investigate your case and answer your questions as best as possible. Call now 1.800-745-4050. Experience law done differently!

 

 

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