SGLT2 Inhibitor Lawyer

Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a new class of diabetic medications indicated only for the treatment of type 2 diabetes. In conjunction with exercise and a healthy diet, they can improve glycemic control.

Drugs in the SGLT2 inhibitor class include empagliflozin, canagliflozin, dapagliflozin, and ipragliflozin (ipragliflozin has not yet been approved for use in the U.S.).

Vaginal yeast infections and urinary tract infections are the most common side effects associated with canagliflozin, with the greatest risk being in female patients and men who are uncircumcised.

There is also an increased desire to urinate and the medication is not indicated in patients with type 1 diabetes, or patients with frequent ketones in their blood or urine, severe renal impairment, end stage renal disease or patients receiving dialysis. Patients should be advised to expect glucose to be in the urine and if they are using urine glucose strips that they will have a positive reading most of the time.

A SGLT2 Inhibitor lawyer at our firm can help you file a lawsuit for damages against the manufacturers of these drugs.

SGLT2 Inhibitor Medications

The chart below contains information about many of the current SGLT2 Inhibitors in use today.

DrugBrandFDA ApprovalManufacturer
CanagliflozinInvokana2013Johnson & Johnson
DapagliflozinFarxiga2014AstraZeneca
Dapagliflozin/Metformin HClXigduo XR2014AstraZeneca
EmpagliflozinJardiance2014Boehringer Ingelheim
Empagliflozin/LinagliptinGlyxambi2015Boehringer Ingelheim

Farxiga

Farxiga (dapagliflozin) is a drug of the gliflozin class used to treat Type 2 diabetes. It was developed by Bristol-Myers Squibb in partnership with AstraZeneca. The U.S. Food and Drug Administration approved dapagliflozin in 2014 for glycemic control, along with diet and exercise, in adults with Type 2 diabetes.

Farxiga is meant to be used with a combination of diet and exercise in order to improve glycemic control and lower blood sugar in adults with type 2 diabetes mellitus. These inhibitors lower a person’s blood sugar by causing the kidneys to remove it through the urine. The FDA approved the combination product dapagliflozin and metformin hydrochloride extended-release — called Xigduo XR — in October 2014.

The Huffington Post reported in April 2014 that Farxiga patients are five times more likely to contract bladder cancer as opposed to patients who took an older diabetes drug, according to studies conducted for the FDA. According to the report, based on the findings of the companies making and selling Farxiga, FDA scientists concluded that the drug might stimulate bladder cancer in patients already at risk. The fear is that patients take diabetes drugs for years, and the longer someone takes this drug, the greater their risk of cancer, the Huffington Post reported.

Glyxambi

Glyxambi is an SGLT2 inhibitor used in combination with diet and exercise to improve glycemic control and lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower a person’s blood sugar by causing the kidneys to remove it through the urine. Invokana lawsuits, filed by claimants and their lawyers, allege that the manufacturers and marketers of SGLT2 inhibitors failed to warn patients and physicians of the increased risks of the kidney failure, other cardiovascular issues, and ketoacidosis.

As Glyxambi is a new drug, there are no recalls or lawsuits yet. However, The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines, which include Glyxambi, may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.

Invokana

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. As of January 5, 2017, there were 79 Invokana or Invokamet lawsuits transferred to the US District Court of New Jersey. These lawsuits have been consolidated.

Invokana (Invokamet) is a type 2 diabetes medicine manufactured by Janssen Research & Development, LLC. The drug is a SGLT2 inhibitor used in combination with diet and exercise to improve glycemic control and lower blood sugar in adults with type 2 diabetes mellitus.

Diabetes is a leading cause of death in the United States and leads to serious medical problems, including kidney failure, blindness, heart disease and other health issues. Invokana was approved by the Food & Drug Administration on March 29, 2013 for treatment of type 2 diabetes. However, in May 2015, the FDA warned in a safety communication that these drug treatments may put patients at risk for a serious health condition known as ketoacidosis.

Jardiance

Jardiance (empagliflozin) is a drug of the gliflozin class used to treat Type 2 diabetes. It was developed by Boehringer Ingelheim. The U.S. Food and Drug Administration approved dapagliflozin in 2014 for glycemic control, along with diet and exercise, in adults with Type 2 diabetes.

As Jardiance is a new drug, there are no recalls or lawsuits yet. However, The U.S. Food and Drug Administration (FDA) is warning that type 2 diabetes medicines, which include Jardiance, may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.

Jardiance is an SGLT2 inhibitor, which is a class of prescription medicines for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.

Xigduo XR

Xigduo XR (dapagliflozin/metformin HCl) is a drug of the gliflozin class used to treat Type 2 diabetes. It was developed by Bristol-Myers Squibb in partnership with AstraZeneca. The U.S. Food and Drug Administration approved dapagliflozin in 2014 for glycemic control, along with diet and exercise, in adults with Type 2 diabetes.

The FDA approved the combination product dapagliflozin and metformin hydrochloride extended-release, Xigduo XR, in October 2014.

As Xigduo XR is a new drug, there are no recalls or lawsuits yet. However, The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines, which include Xigduo XR, may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.

What are the Side Effects of SGLT2 Inhibitors?

Like most medications, SGLT2 inhibitors have a range of normal side effects that can affect the user. Below are some common side effects associated with most SGLT2 inhibitors.

HypoglycemiaNausea
Increased UrinationDiabetic Ketoacidosis
Urinary Tract InfectionGenital Yeast Infections
Upper Respiratory Tract InfectionIncreased Low-Density Cholesterol

There has been concern over additional dangerous side effects that may be associated with the use of SGLT2 inhibitors. Below are some of the most serious complications believed to be associated with SGLT2 inhibitors, which can be the basis of a lawsuit with the help of a lawyer.

Kidney FailureHeart Attack
StrokeDeath
Dehydration Requiring HospitalizationBone Fracture

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).

Reported Complications

Research has shown potential serious side effects of SGLT2 inhibitors. In May 2015, the FDA warned in a safety communication that Invokana drug treatments may put patients at risk for a serious health condition known as ketoacidosis.

The FDA has also issued an alert linking Invokana to an increase in foot and toe amputations. Health Canada has also found a link between Invokana and acute kidney injuries.

The Huffington Post reported in April 2014 that Farxiga patients are five times more likely to contract bladder cancer as opposed to patients who took an older diabetes drug, according to studies conducted for the FDA.

According to the report, based on the findings of the companies making and selling Farxiga, FDA scientists concluded that the drug might stimulate bladder cancer in patients already at risk. The fear is that patients take diabetes drugs for years, and the longer someone takes this drug, the greater their risk of cancer, the Huffington Post reported.

Canagliflozin and other SGLT2 inhibitors are powerful anti-diabetes drugs that prevent the blood from reabsorbing glucose.

The number of low-grade side effects is often considered to be a sign of the drug’s potency, and dry mouths, headaches, abdominal discomfort and other mild or moderate symptoms are often dismissed by the public at large.

But red flags go up when the side effects become serious, as is the case with Invokana. In addition to a loss of bone density, which may be caused by the lack of nutrients in the blood, Invokana has been linked to:

  • Diabetic Ketoacidosis: DKA occurs when the body can no longer burn glucose for fuel and must exclusively rely on fat. When this happens, ketones (waste products) build up in the blood and eventually become toxic.
  • Blood Infections: These issues begin with kidney infections, and may eventually become life-threatening.
  • Stroke: Similar CANVAS trials indicated a 46 percent increase for heart problems in Invokana patients.

These side effects of SGLT2 inhibitors like Invokana can be the basis for a lawsuit with the help of an attorney.

Diabetic Ketoacidosis

A serious complication associated with Invokana is diabetic ketoacidosis.

This is a serious medical condition that occurs when ketones build up in the blood and urine. Ketoacidosis occurs when the body starts breaking down fat cells for fuel when it cannot use glucose (sugar) in the bloodstream because there is too little insulin.

When fat cells break down, they release ketones which make your blood more acidic and can cause your diabetes to go out of control.

Diabetic ketoacidosis can lead to serious medical complications. These include kidney failure, cardiovascular problems, and blood clots. In severe cases, this condition can lead to coma.

The FDA’s review of the FDA Adverse Event Reporting System (FAERS) database between 2013-2015 identified 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes that were treated with SGLT2 inhibitors like Invokana. It should be noted that FAERS includes only reports that were submitted to the FDA, so it is likely that there were also additional cases that the FDA was unaware of.

All of the patients that were diagnosed required hospitalization or treatment in an emergency department. There were also many cases in which, ketoacidosis was not immediately recognized due to the fact that blood glucose levels were below those that were typically expected for ketoacidosis.

If you are using a SGLT2 inhibitors, it is important to be on the look out for potential warning signs of ketoacidosis. Here is a list of some of the more common symptoms:

  • Thirst or an unusually dry mouth
  • Difficulty breathing, including deep or rapid breathing
  • High blood glucose levels
  • Decreased alertness or hard time focusing
  • Deep, rapid breathing
  • Frequent urination
  • Fruity-smelling breath
  • Headaches
  • Muscle stiffness or aches
  • Nausea and vomiting
  • Stomach pain

If you experiencing any of these symptoms, you should seek medical attention immediately. Ketoacidosis is usually treated at the hospital, and if it is caught in time, does not pose a life threatening risk.

Kidney Failure

The FDA received 101 reports of confirmable cases of acute kidney injury between 2013 to 2015, some of these reported cases were sever enough to require hospitalization. The number that the FDA reported was only from cases that were actually submitted to them, it is very likely that there were also additional cases that they are unaware of.

Foot or Leg Amputation

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.

Heart Attack

Heart attacks, or myocardial infarctions, are a potential complication of the diabetes drug Ivokana. A myocardial infarction can damage the cells within the heart and cause permanent damage to the organ. Heart attacks, in some cases, can be fatal.

In May, 2015, the FDA issued a statement that treatment with Ivokana can lead serious medical problems, including cardiovascular problems like myocardial infarction and heart attack.

Damage to the heart can stem from diabetic ketoacidosis when insulin levels are too low. If undiagnosed or treated, the condition can lead to heart failure and cardiac complications.

The FDA required Johnson & Johnson to conduct post-marketing studies as well as a clinical trial after the initial study data showed a troubling increaser in the risk of developing cardiovascular problems such as stroke, blood clots and heart attacks. The Canagliflozin Cardiovascular Assessment Study of (CANVAS) revealed a 46% elevated risk for stroke in the first 30 days of treatment.

There are many heart attack warning signs that you need to pay special attention to, including:

  • Chest pain
  • Bad indigestion
  • Heavy pressure on your chest
  • Light headedness
  • Dizziness
  • Shortness of breath
  • Sweating
  • Fatigue or weakness

You should see your doctor or visit a hospital emergency department if you notice these symptoms in yourself or someone that you care about so that treatment can begin to prevent serious damage to your heart and even sudden death. The physicians may discontinue your use of Ivokana to prevent any permanent damage to your heart or cardiovascular system.

Bladder Cancer

Similar to other forms of cancer, there are several life aspects that factor into an individuals risk of developing bladder cancer. Some of these factors can be controlled by an individual by pursuing certain lifestyles while others are naturally occurring and are not affected by individual actions.

Although accumulation of risk factors cannot serve as an indication of bladder cancer development, they do serve as an indicator of development likelihood. Multiple risk factors may apply to an individual while they still do not develop bladder cancer.

Some of the most influential and notable risk factors that have been identified by members of the medical community includes:

Smoking

Smoking tobacco, whether through cigarettes, cigars, or pipes, has been found to be associated with an increase in diagnosed bladder cases. This is believed to be related to a buildup of chemicals in smokers urine that may damage the lining of the bladder which can lay the foundation for bladder cancer.

Advancing Age 

Most cases of bladder cancer occur in those above the age of 55 by an exceptionally large margin. Although younger individuals are not immune to bladder cancer, the disease is very rare in those below the age of 40.

Chemical Exposure 

Because the bladder is responsible for disposing some chemicals from the body after being filtered by the kidneys, increased exposure to chemicals may damage the lining of the bladder. As chemicals, including arsenic and chemicals present in the rubber, leather, textile, and paint industry, cycle through the body, medical reports indicate that an individuals risk of bladder cancer may steadily rise.

Race & Gender

Regarding race and gender, white individuals report bladder cancer far more common than individuals of any other race. This is also true for men, as they are nearly three times more likely to develop bladder cancer as women.

Family/Personal History 

Those with bladder cancer in their personal or family history of far more likely to experience it than those without a history. When family members have a history of bladder cancer, an individual may have inherited genetics that make them more susceptible to bladder cancer although strictly the genetic form is rare.

Additionally, those who previously had bladder cancer are at a very high risk of suffering from a recurrence of the disease.

Previous Medical Treatments

Various medical treatments can lead to an increased risk of developing bladder cancer. This includes use of cyclophosphamide to treat a previous instance of bladder cancer. Additionally, those who utilized radiation therapy may also carry a heightened risk of recurring bladder cancer.

Those who take diabetes medication, especially Actos have also reported higher rates of bladder cancer than is standard.

Chronic Bladder Inflammation 

Chronic bladder inflammation that may occur when using a long-term urinary catheter may increase the risk of developing bladder cancer.

How to File a SGLT2 Inhibitor Lawsuit with an Attorney

The manufacturers of SGLT2 Inhibitors have been the subject of litigation because of the side effects caused by their drugs.

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 SGLT2 inhibitor lawyers can help if you or someone you care about contracted a severe — or possibly fatal — infection as a result of being exposed to severe side effects this drug causes.

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