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Invokana FAQ

Invokana FAQ

This page contains answers to frequently asked questions about Invokana, a type-2 diabetes drug that has been linked to life-threatening side effects like diabetic ketoacidosis, kidney failure, and more.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Invokana induced injury cases in all 50 states. If you or somebody you know has been diagnosed with ketoacidosis, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

What is Invokana?

Invokana (canagliflozin) is an oral medication that helps people with type-2 diabetes prevent high blood-sugar levels (hyperglycemia). It is sold by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and was approved by the FDA on March 29, 2013.

How Does Invokana Work?

Invokana was the first drug in a new class of diabetes medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. These drugs stop the kidneys from re-absorbing glucose, which results in the kidneys excreting extra glucose in the urine and lowers blood-sugar levels.

How Do I Take Invokana?

The recommended starting dose is a 100-mg pill taken once daily before the first meal of the day. The dose can be increased to 300-mg once daily in patients who tried the lower dose but need better blood-sugar control.

What Is Invokana Approved to Treat?

Invokana is only approved to treat adults with type-2 diabetes, in conjunction with diet and exercise. It is not approved for the treatment of type-1 diabetes or as a weight-loss aid.

Is Invokana a Blockbuster Drug?

Yes. In 2015, sales of Invokana surged to $1.3 billion and doctors wrote over 1.1 million prescriptions. In 2014, Invokana made $586 million in sales.

What SGLT2 Inhibitors Are On the Market?

Should I Use Invokana if I have Type-1 Diabetes?

Invokana is not FDA-approved for people with type-1 diabetes. However, it is sometimes prescribed “off-label,” which means studies have not investigated the risks and benefits. People with type-1 diabetes on Invokana can develop ketoacidosis if they do not get enough insulin, especially after a cold or other illness, even when they have normal blood-sugar levels.

Can Invokana Be Used Alone?

Invokana alone is not very effective at treating diabetes because it only lowers blood-sugar levels (measured by the A1C blood test) by 0.5 to 0.7 percentage points. It is usually used in combination with other diabetes drugs, such as metformin.

Will I Lose Weight on Invokana?

Invokana is not a weight-loss medicine, but it is associated with modest weight-loss in patients who are obese or overweight. In some studies, patients who used Invokana with metformin lost about 2-3% of their body weight, compared to 1% loss on a placebo. Long-term benefits were unclear. Researchers hypothesize that increased glucose excretion in urine could lead to a decline in calories.

How Much Does Invokana Cost?

Invokana costs a lot more than other diabetes drugs. The wholesale cost is $8.77 per pill, according to a spokesperson for Janssen. Retail cost for the 100-mg starting dose is about $10 a pill, or $300 a month. In comparison, the diabetes drug metformin can cost as little as $0.25 per pill, or $7.50 a month.

What Are Common Side Effects of Invokana?

The most common side effects of Invokana are urinary tract infections and vaginal yeast infections. Invokana is a diuretic that causes patients to urinate more often, which can reduce blood-volume and cause dehydration. You may be at higher risk of dehydration if you have low blood-pressure, are on a low-salt diet, have kidney problems, or are over 65 years old.

What Are The Most Serious Side Effects of Invokana?

What FDA Warnings Have Been Issued for Invokana?

May 16, 2017 — FDA requires a “Black Box” warning label that Invokana doubles a patient’s risk of foot and toe amputations.

June 14, 2016 — FDA Safety Communication strengthens warnings about acute kidney injury, which is a type of kidney damage that causes the kidneys to suddenly stop working.

May 18, 2016 — FDA Safety Communication warns about a clinical trial linking Invokana with a doubled risk of leg and foot amputations, mostly affecting the toes.

December 4, 2015 — FDA updates warning labels on Invokana after 73 cases of ketoacidosis were linked to SGLT2 inhibitors from March 2013 to May 2015. The agency also warned about severe urinary tract infections that caused life-threatening complications, such as kidney infections (pyelonephritis) and bloodstream infections (urosepsis).

September 10, 2015 — FDA Safety Communication warns about the risk of bone fractures and decreased bone mineral density, which can occur after just a few months of taking Invokana.

May 15, 2015 — FDA Safety Communication warns that Invokana may lead to diabetic ketoacidosis, a life-threatening condition involving too much acid in the bloodstream.

What Does the FDA Recommend for Patients on Invokana?

“Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones.  Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.”

What Makes Cases of Ketoacidosis Unusual?

Before Invokana hit the market, ketoacidosis was primarily seen in patients with type-1 diabetes who had very high blood-sugar levels. However, Invokana is linked to ketoacidosis in type-2 diabetic patients with normal or moderately increased blood-sugar. Because symptoms are so unusual, diagnosis and treatment could be delayed until the condition becomes life-threatening.

How Many Cases Have Been Reported?

In June 2015, the European Medicines Agency (EMA) warned that 101 cases of diabetic acidosis had been reported worldwide in patients on SGLT2 inhibitors like Invokana.

What Is My Risk of Getting Ketoacidosis?

Your chance of getting ketoacidosis from Invokana is probably low. Janssen Pharmaceuticals researchers looked at data on 17,596 patients and found reports of ketoacidosis in 12 patients, or 0.07% of the sample. Invokana has been prescribed to millions of patients, so it is possible that hundreds developed ketoacidosis. The study was published in July 2015 by Diabetes Care.

Does Invokana Have Higher Risks Than Other SGLT2 Inhibitors?

Invokana patients are more likely to develop ketoacidosis than patients on other SGLT2 inhibitors, and higher doses of Invokana are associated with higher rates of ketoacidosis, according to data from the CANVAS clinical trial reviewed in Diabetes Care.

What Else Increases My Risk?

In some case reports, just before or at the same time ketoacidosis occurred, patients had another illness such as a urinary tract infection, urosepsis, gastroenteritis, influenza, trauma, surgery, reduced caloric or fluid intake, and/or reduced insulin dose.

What Other Warnings Have Been Issued?

Amputations: Preliminary data from the CANVAS clinical trial suggests that patients on Invokana are twice as likely to need an amputation compared to patients on a placebo. In May 2017, the FDA confirmed the risk and ordered manufacturers to add a “Black Box” warning label.

Bone Fractures: The FDA warns that Invokana can decrease bone mineral density and increase the risk of bone fractures (often after minor falls) as early as 12 weeks after starting the drug.

Infections: The FDA warns that Invokana can lead to severe, life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections. At least 19 cases were reported from March 2013 through October 2014, including some patients who needed dialysis for kidney failure.

Why Does Invokana Double the Risk of Amputations?

Two large clincial trials (CANVAS and CANVAS-R) show that patients on Invokana are twice as likely to need a foot, toe, or leg amputation. The problem is that Invokana reduces blood-sugar levels by forcing the kidneys to remove more sugar from the body in urine. This can cause dehydration and reduce the amount of blood in the body, which can cause poor circulation in the feet.

Over time, high blood-sugar also causes the blood vessels to narrow and harden, which worsens circulation problems in the feet. Diabetes can also cause nerve damage in the feet, which makes it hard to feel injuries. These injuries heal very slowly and become infected easily. Amputations are often necessary to control the spread of infections.

Has Invokana Been Recalled?

No. Invokana has not been recalled at this time. However, several deadly side effects are under investigation and will only be understood after millions more patients take Invokana.

What Safety Studies Are Underway?

Janssen is conducting five post-marketing studies, including a new clinical trial, to better understand the risk of heart attack or stroke from Invokana. During clinical trials, 13 patients on Invokana had cardiovascular events in the first 30 days of treatment, compared to just one patient on a placebo. The risk equalized after 30 days.

What is the Risk of Heart Attack or Stroke?

No one knows if Invokana causes heart attacks or strokes. Data from the CANVAS clinical trial found a 46% increased risk of stroke, but only in the first 30 days of treatment with Invokana. The label on Invokana does not include warnings about heart attacks or strokes. Lawyers accuse Janssen of inadequately warning patients and doctors.

Does Invokana Cause Cardiovascular Events?

No one knows if Invokana causes heart attacks or strokes. However, Invokana does cause high cholesterol, including both LDL (“bad”) and HDL (“good”) cholesterol. High cholesterol is a risk-factor for cardiovascular events, especially in older patients and those with risk-factors like high blood pressure or diabetes.

What is Ketoacidosis?

Diabetic ketoacidosis is a life-threatening condition that occurs when the blood becomes too acidic due to high levels of blood-acids called ketones.

What Are Ketones?

Ketones and ketoacids are made in the liver from the breakdown of fat. Ketone levels normally increase overnight or when dieting. They are part of the body’s normal adaptation to avoid starvation when you haven’t eaten for a while. However, in people with diabetes, high ketone levels are a sign of uncontrolled blood-sugar levels or a shortage of insulin.

What Else is Ketoacidosis Called?

Other names for diabetic ketoacidosis include DKA, diabetic acidosis, metabolic acidosis, or ketosis.

What Causes Acidosis?

It occurs when the body cannot use glucose (sugar) in the bloodstream as a source of energy because it does not have enough insulin. Instead, it starts burning fat. When fat cells break down, they release fatty-acids that are converted into ketones by the liver. As ketone levels increase, blood pH becomes very acidic and health problems occur.

What Are Risk-Factors for Metabolic Acidosis?

  • Emotional or physical stress
  • Recent infection, such as a urinary tract infection (UTI), pneumonia, sepsis, etc.
  • Illnesses or fever
  • Having surgery
  • Eating less due to illness, surgery, dieting or another reason
  • Pancreatitis (pancreas inflammation) or other pancreas problems
  • Drinking alcohol often or drinking a lot of alcohol at once
  • Certain medications, such as corticosteroids and some diuretics

How Can I Prevent DKA?

  • Never skip an insulin dose if you have type-1 diabetes..
  • Eat enough food and drink extra water when your blood-sugar is high.
  • If you are sick (vomiting or diarrhea) or stressed out, you should check your blood-sugar level more often than normal — at least every 3 to 4 hours.
  • If you are having health problems, test ketone levels in your urine every few hours, especially if your blood-sugar is over 250-mg/dL.
  • Seek medical attention if your ketone levels are higher than normal

What Are Symptoms of Ketoacidosis?

Diabetic acidosis can develop in less than 24 hours. Symptoms may include:

  • Nausea and vomiting
  • Abdominal pain
  • Frequent urination
  • Excessive thirst
  • Dehydration
  • Low blood pressure
  • Deep, rapid breathing
  • Dry skin and mouth
  • Flushed face
  • Fruity-smelling breath
  • Headache
  • Muscle stiffness or aches
  • Confusion or decreased alertness
  • Coma (unconsciousness)

How Do I Know If I Have Ketoacidosis?

  • Measure your blood-sugar level. High blood-sugar is a sign of ketoacidosis, but cases can also occur in people with normal blood sugar levels below 240 mg/dl.
  • Measure ketone levels in your urine or blood with a test strip or dipstick.
  • Hospitalized patients may have a blood test to measure the acidity of the blood.

What Tests Are Used to Diagnose DKA?

The first step to diagnosing ketoacidosis is checking ketone levels in a sample of urine. Tests for blood-sugar and blood-acidity are also common. In the hospital, your doctor may order a potassium blood-test to assess metabolic function, or an arterial blood gas test to determine the acidity of your blood.

What Are Complications of Acidosis?

Ketoacidosis can lead to life-threatening dehydration, fluid/electrolyte imbalances, high blood-sugar (hyperglycemia), fever, heart problems (cardiac arrest), respiratory failure, cerebral edema (swelling in the brain), seizures, diabetic coma, and death.

How is Ketoacidosis Treated?

Treatment for ketoacidosis focuses on restoring normal blood-sugar levels with intravenous (IV) insulin, balancing electrolytes and minerals (especially potassium) in the bloodstream, and bringing fluid levels back to normal. People who are diagnosed with ketoacidosis must be hospitalized and receive intensive care.

Are There Long-Term Risks?

If ketoacidosis is diagnosed and treated early, most people go home from the hospital within a couple days and recover without any long-term side effects. However, if it is not treated promptly, it can become life-threatening.

Can Ketoacidosis Cause Brain Damage?

Yes. One the most serious complications that occurs during treatment for DKA is cerebral edema (swelling in the brain). It usually occurs in children who are given fluids too quickly. It has a high mortality rate and a substantial percentage of survivors are left with permanent brain damage. Symptoms include headache, vomiting, slow heart-rate, high blood pressure, drowsiness, irritability, seizures, and more.

How Many Cases of Ketoacidosis Have Been Linked to Invokana?

From March 2013 (when Invokana was approved) to May 2015, the FDA received 73 reports of patients who developed ketoacidosis. In 2015, the FDA received over 150 reports of patients on Invokana who developed metabolic acidosis. Click here to read more.

Can Ketoacidosis Cause Heart Attack?

Ketoacidosis can cause the heart to stop working. This is called cardiac arrest, and it is not the same thing as a heart attack. Cardiac arrest occurs when the heart suddenly stops beating or is unable to pump enough blood to the body. A heart attack occurs when a blocked artery stops blood-flow to the heart muscle.

Can I Use Invokana if I Have Kidney Problems?

Do not take Invokana if you have severe renal impairment, chronic kidney disease, end-stage renal disease (ERSD), or are on dialysis. Invokana relies on the kidneys to work, and it increases the risk of kidney side effects due to infections and reduced blood-volume. Patients should have their kidney function assessed before starting Invokana. In patients with mild kidney problems, the dose should be limited to 100-mg a day.

Does Invokana Increase Cholesterol?

Yes. Invokana can increase LDL (“bad”) cholesterol and HDL (“good”) cholesterol levels. Higher doses of Invokana were linked to cholesterol level increases up to 8% compared to a placebo. High cholesterol is a risk-factor for heart attacks and strokes.

Can Invokana Lower Blood Pressure?

Yes. Invokana causes increased urination. This can deplete fluids in the body and lead to reductions in blood-volume, which can cause low blood pressure, dizziness when standing, loss of consciousness, dehydration, and kidney problems.

Does Invokana Have a “Black Box” Warning?

No. Invokana does not have a “Black Box” warning about ketoacidosis as of January 2016. However, there is a “Black Box” warning on Invokamet, which contains metformin, about the risk of lactic acidosis.

Can I Get Dehydrated From Invokana?

Yes. Invokana is a diuretic that can cause some people to have dehydration (loss of body water and salt). It can lead to severe kidney problems, electrolyte imbalances, heart problems, low blood pressure, and even death. The symptoms in adults may include:

  • Thirst
  • Urinating less often than usual
  • Dark-colored urine
  • Dry skin
  • Dry mouth and tongue
  • Feeling tired
  • Dizziness and fainting

Can I File a Lawsuit for Kidney Failure?

Our lawyers are investigating potential lawsuits involving kidney failure. In the first 12 months Invokana was on the market, the FDA received over 50 reports of renal impairment or kidney failure. The FDA has also received reports of people who developed kidney failure due to a urinary tract infection that spread to the kidneys (pyelonephritis).

Have Kidney Failure Lawsuits Been Filed?

Yes. Invokana relies on the kidneys to remove sugar from the body and it is not recommended for people with pre-existing kidney disease. The label only warns that “kidney problems” are a “possible side effect” The label does not specifically address kidney failure or the extent of the problem associated with Invokana. A few examples of lawsuits include:

  • February 29, 2016: Lawsuit (PDF) was filed in federal court in California by a woman who was hospitalized with kidney failure in March 2015.
  • February 19, 2016: Lawsuit (PDF) filed in Kentucky by a woman who was hospitalized with kidney failure in February 2015.
  • December 14, 2015: Lawsuit (PDF) filed in Tennessee by a man who started taking Invokana in November 2013 and developed kidney failure (Case No. 2:15-cv-02799).

What Other Side Effects Cause Kidney Failure?

Dehydration and infections are two common side effects of Invokana that can cause kidney failure in rare cases. Severe dehydration decreases the amount of blood in the body, which makes it harder for the kidneys to function. At least 5% of Invokana patients develop urinary infections, which sometimes spread to the kidneys can cause acute kidney failure. Infections can also permanently scar the kidneys and cause Chronic Kidney Disease (CKD). The FDA has also warned about urinary infections spreading to the bloodstream and causing urosepsis, which can cut off blood-flow to the kidneys and cause kidney failure.

What Are Symptoms of Kidney Failure?

  • Fatigue and weakness
  • Generally feeling sick
  • High blood pressure
  • Swelling in the legs and feet (edema)
  • Persistent itching
  • Changes in urine output
  • Lack of appetite and weight-loss
  • Nausea and vomiting
  • Problems controlling blood-sugar levels
  • Heart rhythm problems
  • Bad taste in the mouth
  • And more

What is the Risk of Kidney Failure?

Kidney failure is an uncommon side effect of Invokana, but it is a common problem in people with diabetes. About 20-40% of people with type-1 or type-2 diabetes develop nephropathy, which is a progressive kidney disease that occurs after years of high blood-sugar and blood pressure damages the delicate filtration structures inside the kidneys. Over time, people with nephropathy can lose kidney function and develop kidney failure. Diabetes is a leading cause of kidney failure in the United States.

Have Ketoacidosis Lawsuits Been Filed?

Yes, the first lawsuits were filed in Philadelphia and Alabama in December 2015 by plaintiffs who took Invokana and developed ketoacidosis. Our lawyers are now accepting potential lawsuits on behalf of individuals who were injured by ketoacidosis after taking Invokana. Click here to read more.

What Do Lawsuits Allege?

  • Negligence
  • Failure to warn about side effects
  • Concealing knowledge of side effects
  • Inadequately testing it for side effects
  • Misrepresenting risks and benefits
  • Manufacturing a defective drug
  • Marketing for “off-label” uses like weight-loss, type-1 diabetes, high blood pressure.

Has There Been A Settlement?

No. There have been no reports of any Invokana settlements. The first lawsuits were filed in 2015 and they are still in the early stages of litigation. It will likely be several more years until Janssen Pharmaceuticals considers offering a settlement.

Has a Class Action Been Filed?

No. The Schmidt Firm, PLLC is nationally recognized as a class action law firm. However, our attorneys are not currently filing an Invokana class action. Instead, we are filing individual lawsuits against Janssen Pharmaceuticals for selling a defective drug and failing to warn about side effects.

How Much Time Do I Have to File a Lawsuit?

The amount of time you have to file a lawsuit depends on the state where you live. Every state has its own rules called the “statute of limitations.” In some states, it can be as little as one year from the time you were injured. It is a good idea to talk to a lawyer as soon as you think you have a case.

How Can a Lawyer Help?

Our attorneys will review your case for free and let you know if you might qualify to file a lawsuit. If you decide to file a lawsuit and join this growing litigation, we may be able to help you seek justice and compensation for your pain and suffering, medical expenses, lost income, permanent injuries, and more.

What Damages Could I Recover?

Our attorneys will fight for financial compensation for your physical injuries and economic losses. Lawsuits that go to trial could also be awarded punitive damages if a jury decides to punish drug-makers for wrongdoing. Some examples of compensatory damages include:

  • Physical and emotional pain and suffering
  • Medical bills
  • Rehabilitation
  • Disability or long-term injuries
  • Lost wages
  • Wrongful death and funeral expenses
  • And more

Do I have an Invokana Lawsuit?

The Schmidt Firm, PLLC is currently accepting Invokana induced injury cases in all 50 states. If you or somebody you know has been diagnosed with ketoacidosis, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

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