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Side effects of the type 2 diabetes drug Invokana may include ketoacidosis, heart attack, stroke, kidney failure, urinary tract infections and more. The medication has also recently been linked to a higher risk for amputation of the leg, foot and toes.
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Medical Devices

What is Invokana?

Invokana (generic: canagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor drug used to control blood sugar and reduce blood pressure in patients with type 2 diabetes, a disease that affects nearly 30 million Americans -- almost 10% of the U.S. population -- each year. The revolutionary drug works by increasing the removal of glucose and blood sugar from the kidneys.

Invokana was developed by Mitsubishi Tanabe Pharma pharmaceutical company, and is marketed under license by Janssen, a division of Johnson & Johnson.

SGLT2 Inhibitors May Cause Ketoacidosis: U.S. Food and Drug Administration

On May 15, 2015, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication warning that Invokana and other SGLT2 inhibitors had been linked to diabetic ketoacidosis (also known as "DKA," "diabetic acidosis," "metabolic ketoacidosis" or "ketoacidosis").

From March 2013 to June 6, 2014, at least 20 cases of ketoacidosis in patients who used these diabetes medicines were reported to the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) [1].

Diabetic ketoacidosis does not usually occur in patients with type 2 diabetes, according to the Food and Drug Administration, and the reports were "atypical in that glucose levels were only mildly elevated at less than 200 mg/dL in some reports, while patients with type 1 diabetes who have DKA typically have glucose levels greater than 250 mg/dL."

As a result of these problems, on Dec. 4, 2015, the U.S. Food and Drug Administration announced new warnings to the products’ labeling regarding ketoacidosis and serious UTIs. The new labels will include information about the side effects, as well as prescribing and monitoring recommendations for healthcare providers.

Which Drugs are SGLT2 Inhibitors?

In addition to Invokana, other diabetes medications in the SGLT2 inhibitor class include:

Ketoacidosis Symptoms

  • Difficulty breathing
  • Nausea
  • Vomiting
  • Abdominal pain
  • Confusion
  • Fatigue
  • Sleepiness
  • Lower blood sugar
  • Lower blood glucose levels
  • Low bone mineral density

Source: Mayo Clinic [2]

Patients with any of these symptoms should contact the physicians who prescribed Invokana. However, the U.S. Food and Drug Administration cautions that patients should never stop taking their diabetes medications without talking to their prescribing doctor first.

Reduce Blood Sugar Levels

Invokana Side Effects

Invokana lawsuits allege the following serious side effects:

  • Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Metabolic Ketoacidosis, Ketoacidosis)
  • Diabetic Coma
  • Heart Attack (Myocardial Infarction or MI)
  • Kidney Damage
  • Kidney Failure (Renal Failure / Kidney Cancer / Kidney Infections / Pyelonephritis / Kidney Stones)
  • Kidney Transplant
  • Lower Limb Amputation
  • Leg amputations
  • Bone Fractures / Bone Abnormalities
  • Bone Fractures / Kidney Cancer
  • Stroke
  • Testicular Cancer
  • UTIs
  • Severe Dehydration / Fluid Imbalance
  • Abnormal Weight Loss
  • Hypersensitivity (Allergic Response)
  • Blood Infections (Urosepsis)
  • Fungal Infections
  • Yeast Infections (both men and women)

Invokana Kidney Failure

Invokana lowers blood glucose levels by blocking the kidneys from reabsorbing glucose, causing some to be excreted from the body through the urine. However, it is believed that this same mechanism of action increases a higher risk of kidney problems and UTIs.

Related Article: Nexium Kidney Failure Lawsuit

Signs and symptoms of kidney failure include:

  • Reduced amount of urine
  • Swelling in the legs, ankles, and/or feet
  • Unexplained shortness of breath
  • Excessive drowsiness or fatigue
  • Nausea
  • Confusion
  • Pain / pressure in your chest
  • Seizures
  • Coma
  • Lower blood pressure

Source: Healthline [3]

How Can Invokana Cause Serious Urinary Tract Infections?

Invokana can treat weight loss by increasing levels of creatinine, a breakdown product of creatine phosphate in muscle tissues that is usually excreted in the urine through the kidneys. Therefore, Invokana users are more likely to have their kidneys return creatinine to the bloodstream, which, at increased levels, can cause impaired kidney function.

FDA is aware of dozens of cases of life-threatening kidney infections associated with Invokana. Many of these Invokana side effects started as UTIs which progressed into kidney or blood infections.

FDA Strengthens Kidney Warnings on Invokana

The FDA revises labels for the type 2 diabetes medication canagliflozin -- the active ingredient in Invokana and Invokamet -- related to a risk for bone fractures, according to a drug safety communication issued September 10.

To address these concerns, the agency has added a new “Warning and Precautions” section and revised the “Adverse Reactions” section of the Invokana and Invokamet drug labeling.

Before Taking Invokana

Before taking Invokana, be sure to tell your doctor if any of the following risk factors apply to you, as they increase your likelihood of complications:

  • Kidney disease
  • Liver disease
  • Heart disease
  • High blood pressure
  • Low blood pressure
  • Elevated blood acids
  • An electrolyte imbalance
  • High cholesterol
  • Genital infection
  • If you are on a low-salt diet
  • If you take insulin or another diabetes drug
  • It is unknown whether Invokana can harm a fetus or an infant being breastfed, so make sure to talk to your doctor if you are pregnant or plan on becoming pregnant

Study Links Invokana to Doubled Risk of Amputation

October 1, 2019 - Diabetes patients who took Invokana had a doubled risk for amputations of the toes or feet compared to patients who took a placebo, according to a recent study.

Data presented at the 2019 annual meeting of the American Diabetes Association (ADA) [5] indicated that Invokana can significantly reduce the risk of severe heart problems in diabetes patients with established or elevated risk for heart disease.

FDA Requires 'Black Box Warning' on Amputation Risk with Invokana

May 16, 2017 - FDA has concluded that patients who take the SGLT2 inhibitors Invokana and Invokamet for the treatment of type 2 diabetes face an increased risk of leg and foot amputations. Based on data from 2 large trials -- the CANVAS and CANVAS-R [7] studies -- FDA is requiring that labels of Invokana, Invokamet and other SGLT2 inhibitors be updated with a boxed warning about an increased risk of amputations associated with use of the drugs.

Two Clinical Trials

Invokana Lawsuits Consolidated in New Jersey

December 19, 2016 - A panel of judges has ordered that all federal Invokana lawsuits alleging ketoacidosis and kidney failure will be transferred to the District of New Jersey for consolidation into a multidistrict litigation (MDL) before Judge Brian R. Martinotti.

Johnson & Johnson and its subsidiary Janssen Pharmaceuticals currently face about 55 Invokana lawsuits in state courts across the U.S. The complaints allege that the companies failed to adequately warn about the risk of Invokana side effects, which include diabetic ketoacidosis, kidney failure, heart attack, stroke and more.

FDA Strengthens Acute Kidney Injury Warning on Invokana

June 14, 2016 - The Food and Drug Administration has upgraded existing warnings about the risk of acute kidney injury with SGLT2 inhibitors (Invokana, Invokamet, Farxiga, Xigduo XR). From March 2013 to October 2015, the agency received at least 101 confirmable reports of the condition — some requiring emergency hospitalization and dialysis treatment — associated with the drugs.

Invokana Elevates Risk of Ketoacidosis-Related Events in Type 1 Diabetics, Study Finds

June 13, 2016 - In a Phase II study of type 2 diabetes patients, Invokana administered with insulin was superior to a placebo-insulin combo at both lowering mean glucose levels and glycemic variability, according to FiercePharma [7].

However, the drug also increased the rate of serious adverse events related to diabetic ketoacidosis.

Still, Janssen is continuing to explore the potential for Invokana as a treatment for type 1 diabetes, in part because “there have not been a great number of targets for intervening in the disease,” according to Jim List, Janssen’s global head of cardiovascular and metabolism.

Invokana Lawsuits Filed in Illinois

April 29, 2016 - An Illinois man who allegedly suffered kidney damage after taking Invokana has filed a products liability lawsuit against Janssen Pharmaceuticals. According to the lawsuit, plaintiff began taking Invokana to treat his type 2 diabetes in September 2013, and shortly thereafter developed severe kidney injuries which resulted in physical and emotional damages including “pain and suffering, emotional distress, loss of enjoyment of life, and economic loss including significant expenses for medical care and treatment which will continue in the future.”

FDA Issues Invokana Amputation Warning

May 18, 2016 - The interim safety results from an ongoing clinical trial found an increase in leg and foot amputations -- mostly affecting the toes -- associated with canagliflozin, the active ingredient in Invokana, according to an FDA Drug Safety Communication issued today. Healthcare professionals have been advised to follow the recommendations in canagliflozin drug labels and to monitor patients for "any new pain or tenderness, sores or ulcers, or infections in their legs or feet,” the agency said.

Invokana Linked to Ketone-Related Events in Type 1 Diabetics, Study Finds

April 14, 2016 - Following a recent warning by the FDA which suggested that type 2 diabetics who take Invokana may face an increased risk of acid buildup in their blood, a new study [8] has identified a similar risk in patients with type 1 diabetes.

For the study, a research team led by Anne L. Peters, MD, of the Keck School of Medicine at the University of Southern California looked at data from 351 type 1 diabetes patients with baseline HbA1c 7% to 9%. Test subjects were on a stable insulin regimen of multiple daily insulin injections or continuous subcutaneous insulin infusion for a minimum of 8 weeks prior to screening.

Has There Been a Recall?

To date, Invokana has not been recalled in the U.S. or any other country. However, the drug has only been on the market a short time (Invokana was approved in March 2013) and the investigation into its potential health risks is still in its early stages. It often takes many years and countless hours of attorney time before all the facts leading to a recall emerge.

Lawsuit Allegations

Some of the claims made in Invokana lawsuits accuse the drug manufacturer of:

  • Failure to warn of risks
  • Negligence
  • Manufacturing a defective drug
  • Misrepresenting the dug's risks and benefits

Because there is a time limit to file your claim, it is important that you seek professional legal advice quickly if you feel you were injured by Invokana.

Related Article: Dangerous Pharmaceuticals Cases We've Taken on

Two Large Clinical Trials

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The Pharmaceutical Litigation Group at our law firms is an experienced team of trial lawyers that focus on the representation of plaintiffs in Invokana lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

If you or a loved one was injured by the side effects of Invokana, you should contact our law firm immediately to pursue legal action. You may be entitled to file an Invokana lawsuit for medical bills and we can help.

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