Invokana Injury Lawsuits: Frequently Asked Questions

What is Invokana?

Invokana was the first in a new class of medications for use in the treatment of Type II diabetes to gain FDA approval in the United States. In phase III clinical trials, Invokana improved blood glucose control and reduced body weight and systolic blood pressure. Invokana is called a sodium glucose co-transporter 2 inhibitor, meaning it reduces blood glucose by acting on the kidneys, increasing the loss of glucose in the urine. As glucose is filtered out of the bloodstream into the kidneys, it is typically reabsorbed back into the bloodstream. The carrier responsible for the reabsorption is the SGLT2, which is selectively inhibited by Invokana, promoting the loss of glucose in the urine. Invokana is not for use among those with Type I diabetes, however may be used in conjunction with other diabetes drugs in those with Type II diabetes, particularly Metformin.

 

What is the FDA’s Stance on Invokana?

Although the FDA approved Invokana in March 2013, there were some concerns regarding the drug at the time it was approved. Janssen, a subsidiary of Johnson & Johnson, conducted nine clinical trials prior to submitting Invokana for FDA approval. Over 10,000 patients with Type II diabetes took part in these clinical trials, however the FDA’s approval came with a caveat: Janssen was required to conduct another five post-market, long-term studies. The first of these studies was a cardiac health study to determine whether Invokana carried any undue cardiovascular risks, including heart attack or stroke.

 

The second study will determine whether Invokana increases the risk of renal failure, pancreatitis, liver problems or breast or bladder cancers. Two pediatric studies will be undertaken, as well as a study to determine whether Invokana brings any additional bone safety issues. With the problems now associated with other types of diabetes drugs such as Byetta, Januvia and Victoza which are incretin drugs rather than SGLT2 inhibitors like Invokana, it would seem extra caution would be exercised regarding new diabetes drugs.

 

What are the Dangers and Risks Associated with Invokana?

In the initial clinical trials for Invokana, it appeared there was an increased risk of adverse cardiovascular event (heart attack or stroke) during the first thirty days the patient took the drug. After the thirty days, that risk appeared to have diminished, although an increase in both LDL and HDL cholesterol was seen in a significant number of patients. A similar diabetic drug, Farxiga, was initially denied FDA approval, due to a potential risk of breast and bladder cancer as well as a lack of sufficient studies.

 

The drug was later approved, however those initial concerns have carried over to Invokana--likely the reason the FDA required additional long-term studies. Invokana works as a diuretic, therefore those taking the drug could experience some level of dizziness. This is an area of concern particularly for the elderly. Invokana is contraindicated among those with severe renal impairment, end-stage renal disease or those currently on dialysis.

 

Since its approval by the FDA, there have been a significant number of adverse event reports come in to the FDA regarding much more serious issues. The FDA has subsequently warned the public regarding potential kidney failure after taking Invokana, as well as bone deterioration, ketoacidosis, and has required a Black Box warning on Invokana regarding a heightened risk of leg and foot amputations for those taking the drug.

 

What Side Effects Have Been Associated with Invokana?

The more common side effects among those taking Invokana are yeast infections among women, urinary tract infections and low blood sugar. Symptoms of low blood sugar include rapid heartbeat, sweating, shakiness or jittery feelings, irritability, confusion, drowsiness, weakness, headaches and hunger. Dehydration may also occur in those taking Invokana, particularly in those who have low blood pressure, take other diuretics, are on a low sodium diet, are older than 65 or have diagnosed kidney problems.

 

Do I Have an Invokana Lawsuit?

Many feel that manufacturer-sponsored clinical trials are a clear conflict of interest.  In short, company-funded research simply tends to favor that company’s product—or drug, in this case. As an example, in an analysis of 107 drug trials published in five leading medical journals, almost 90% of company-funded trails favored the new drug as compared to traditional drug therapies while only 61% of trials not-funded by industry favored the new drug over traditional drug therapies. This is a bit of a red flag, when we are told by the manufacturer that the drug is perfectly safe.

 

There are many lawsuits being filed against Janssen and Johnson & Johnson for injuries suffered by patients taking Invokana. Invokana ketoacidosis, Invokana kidney disease and Invokana amputation are all very serious issues associated with the drug. Further, many plaintiffs are claiming failure to warn and negligence on the part of Invokana manufacturers. If you have been injured by Invokana, it is important that you contact an experienced Invokana injury lawyer as soon as possible.  

 

Are There Other SGLT2 Inhibitor Drugs That Are Potentially Dangerous?

There are four types of diabetic drugs currently on the market:

  • Biguanide drugs like Metformin work by increasing insulin sensitivity.
  • Thiazolidinediones medications such as Avandia and Actos increase insulin sensitivity and decrease insulin resistance.
  • Incretin therapy drugs such as Byetta, Januvia and Victoza are now the focus of mass litigation due to an increased risk of pancreatic cancer.
  • Sodium-Glucose Co Transporter 2 Inhibitors, including Invokana, Farxiga, Glyxambia, Jardiance and Xigduo XR.

 

The incretin therapy drugs as well as the SGLT2 inhibitor drugs have all had adverse reports from patients.

 

How Can an Invokana Injury Lawyer Help Me?

If you have suffered harm as a result of taking Invokana—or any other similar drug, for that matter—it is important that you seek qualified medical assistance first, then once your health is taken care of, you must speak to an experienced Invokana injury lawyer. The Sullo & Sullo attorneys have the necessary experience and knowledge to ensure their clients’ rights are fully protected at all times. We believe your safety and health should be the top priority of drug manufacturers rather than their financial bottom line, and will work hard to provide you with the information you require while protecting your rights and your future. 

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