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Ryan R. Bradley
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Invokana Kidney Problems are just the Tip of the Iceberg: SLGT2 Inhibitors Breakdown Part One

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Koester & Bradley has been Investigating Invokana Due to Serious Injuries

Koester & Bradley Invokana LawyersRecently, in light of the hard times that have befallen Johnson & Johnson in relation to a massive Pinnacle Metal on Metal hip verdict, a large Talcum Powder Verdict, and a spate of mesh verdicts, significant attention has also been given by the consumer protection and products liability community to Invokana.  Initially touted as somewhat of a miracle drug by Janssen Pharmaceuticals, Johnson & Johnson’s drug company, after clinical trials in 2013-2014, Invokana presented a new approach to treating the growing epidemic posed by Type-2 Diabetes in the United States.  Unfortunately, by 2015, The Us Food and Drug Administration (FDA) had so many adverse events related to Invokana that it had to issue a formal warning.  In the next few editions of the Central Illinois Legal Examiner, Koester & Bradley will break down the Invokana Lawsuits, describe how Invokana and SGLT2 inhibitors work, and outline the serious side effects that are tied to the class of drugs that were poised to revolutionize Diabetes treatment. We will start with the basics.

Diabetes is an Epidemic in the United States

It is important to understand that there are essentially two types of Diabetes, Type 1 and Type 2.  According the the American Diabetes Association,

“Type 1 diabetes is usually diagnosed in children and young adults, and was previously known as juvenile diabetes. Only 5% of people with diabetes have this form of the disease.

In type 1 diabetes, the body does not produce insulin. The body breaks down the sugars and starches you eat into a simple sugar called glucose, which it uses for energy. Insulin is a hormone that the body needs to get glucose from the bloodstream into the cells of the body. With the help of insulin therapy and other treatments, even young children can learn to manage their condition and live long, healthy lives.”

- See more at: http://www.diabetes.org/diabetes-basics/type-1/?loc=db-slabnav#sthash.8DI5Rxbc.dpuf

Conversely, In Type -2 Diabetes your body that causes blood glucose (sugar) levels to rise higher than normal. This is also called hyperglycemia. Type 2 diabetes is the most common form of diabetes and is also commonly know as adult-onset diabetes.  For many people, diet and exercise can prevent, or even reverse, Type-2 diabetes.  For the vast majority of people suffering from Type-2 Diabetes however, medication is needed to prevent serious injury.

The core science behind Diabetes is simple, if you have type 2 diabetes your body does not use insulin properly.  Insulin is simply a hormone produced in the pancreas that regulates the amount of glucose in the blood.  This is called insulin resistance. At first, your pancreas makes extra insulin to make up for it. But, over time it isn’t able to keep up and can’t make enough insulin to keep your blood glucose at normal levels. This process can take a very long time to become problematic, which is why many individuals suffering from Type-2 Diabetes are not diagnosed.

The statistics on Type-2 Diabetes are staggering.  According to the Centers for Disease Control (CDC) in 2014:

  • 29.1 million people or 9.3% of the population have diabetes.
  • 21.0 million people have seen a doctor about the condition and been adequately diagnosed.
  • 8.1 million people (27.8% of people with diabetes) are not diagnosed.
  • Diabetes impacts individuals of all ages and is rising quickly among those under the age of 18.

Invokana was developed and designed to treat Type-2 Diabetes.

Invokana and Other SGLT2 Inhibitors Treat Diabetes in a Different Way

Invokana is the Johnson & Johnson brand name for canagliflozin.  This is one of several drugs that belong to a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors.  This calss of medications is very new in the Diabetic treatment market. Thus, when a person consumes food or drink other than water, the body produces insulin to process sugar that enters the body. In people with Type 2 diabetes, this response no longer works the way it should, and they develop insulin resistance. Over time, in many cases many years, the pancreas can’t keep up with the demand for insulin and as a result, sugar levels rise to dangerous levels.  Type-2 Diabetes can result in an number of terrible complications, which, according to the Mayo Clinic include:

  • Heart and blood vessel disease. Diabetes dramatically increases the risk of various cardiovascular problems, including coronary artery disease with chest pain (angina), heart attack, stroke, narrowing of arteries (atherosclerosis) and high blood pressure.
  • Nerve damage (neuropathy). Excess sugar can injure the walls of the tiny blood vessels (capillaries) that nourish your nerves, especially in the legs. This can cause tingling, numbness, burning or pain that usually begins at the tips of the toes or fingers and gradually spreads upward. Poorly controlled blood sugar can eventually cause you to lose all sense of feeling in the affected limbs. Damage to the nerves that control digestion can cause problems with nausea, vomiting, diarrhea or constipation. For men, erectile dysfunction may be an issue.
  • Kidney damage (nephropathy). The kidneys contain millions of tiny blood vessel clusters that filter waste from your blood. Diabetes can damage this delicate filtering system. Severe damage can lead to kidney failure or irreversible end-stage kidney disease, which often eventually requires dialysis or a kidney transplant.
  • Eye damage. Diabetes can damage the blood vessels of the retina (diabetic retinopathy), potentially leading to blindness. Diabetes also increases the risk of other serious vision conditions, such as cataracts and glaucoma.
  • Foot damage. Nerve damage in the feet or poor blood flow to the feet increases the risk of various foot complications. Left untreated, cuts and blisters can become serious infections, which may heal poorly. Severe damage might require toe, foot or leg amputation.
  • Hearing impairment. Hearing problems are more common in people with diabetes.
  • Skin conditions. Diabetes may leave you more susceptible to skin problems, including bacterial and fungal infections.
  • Alzheimer’s disease. Type 2 diabetes may increase the risk of Alzheimer’s disease. The poorer your blood sugar control, the greater the risk appears to be. The exact connection between these two conditions still remains unclear.

Source: http://www.mayoclinic.org/diseases-conditions/type-2-diabetes/symptoms-causes/dxc-20169861

Before Invokana, most Diabetes drugs were designed to simply increase the amount of insulin produced by the body to make up for the inability of Diabetics to produce their own. Invokana and other SGLT2 inhibitors work by preventing sugar from being reabsorbed into the blood.

While many drugs work to increase insulin, Invokana works by stopping glucose from being reabsorbed into the blood in the kidneys. A special protein in the kidney called SGLT2 is responsible for reabsorbing 90 percent of the glucose in the kidneys and this is the particular protein that Invokana and other SGLT2 inhibitors target.  Instead of reabsorbing the sugar, the kidneys secrete it, and it leaves the body during urination. This results in lowered levels of glucose in the blood and can help those with Type-2 Diabetes.  With so many people suffering from adult on set Diabetes, Johnson & Johnson by way of Janssen Pharmaceuticals, saw an excelent opportunity to gain market share through pursuing SGLT2 inhibitors.

Where there is a Medical Problem there is Money to be Made by Johnson & Johnson

Like most large drug companies, Johnson & Johnson has its eyes pointed consistently at the bottom line, and Type-2 Diabetes was a gold mine.  The company reportedly spent millions on research and development of Invokana in hopes of ultimately reaping a pay day.  In March 2013, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s Invokana, which was the first drug in the class and thus supplied JNJ with a first mover advantage, which, in the world of Big Pharma, is a very good positions. Then, in 2014, the FDA approved Invokamet (canagliflozin and metformin).  Johnson & Johnson was quick to sing its own praises when it announced Invokana’s approval by the FDA and the results of the 104 week trial.  The market also took notice as investing websites such as the Motley Fool and Bloomberg reported JNJ’s fabulous rise in share price despite set backs with DePuy Metal on Metal hip settlements in the billions or dollars.  Much of Johnson & Johnson’s success in 2014 and 2015 was driven by sales of Invokana which tripled from 2014 to 2015 to $278 million according to Bloomberg.  The profits were not surprising with a wholesale cost of $8.77 cents per pill.  By May of of 2015, Johnson & Johnson had a blockbuster on its hands with Invokana.

Whenever a new drug makes the kind of money that Invokana did, other companies are sure to follow with their own drugs in the same class.  Such was the case with SGLT2 inhibitors.  As time passed other similar drugs hit the market under the names, nvokamet, Farxiga, Xigduo XR, Jardiance or Glyxambia.  SGLT2 were proving to be a gold mine when in May of 2015 the FDA issued a report outlining the dangers relating to Invokana that made it clear that in many situations, the Invokana side effects are worse than Diabetes itself.

Patients Taking Invokana Are at Risk According to the FDA

The Food and Drug Administration issued its first drug safety communication in May 2015 that warned patients and doctors that Invokana – and other SGLT2 inhibitors – may lead to diabetic ketoacidosis (DKA). This condition can be fatal if left un-treated.

Then, in December 2015, the FDA ordered manufacturers of SGLT2 inhibitors to add warnings regarding the risk of ketoacidosis and urinary tract infections to the drugs’ labels. Patients who developed ketoacidosis or UTIs after taking the drugs sought legal guidence and law suits were filed claiming the drugs’ manufacturers failed to warn of the risks of the drugs. People who filed lawsuits also said the drugs caused strokes, blood clots and acute kidney injuries that required hospitalization.  Koester & Bradley has been investigating these Invokana cases since December.  In the next Part of the Invokana Breakdown we will discuss the harmful side effects caused by SGLT2 inhibitors and what to look for if you are taking them.

1 Comment

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  1. Kenneth says:
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    Why just the tips of iceberg? Having just been diagnosed with stage 3 kidney disease I was anxious for any and all info I could find on the subject. This little book on http://www.kidneycurer.com/ (I read it in just over an hour) was full of very useful information. It is written in language a non-medical person can understand. In fact, when I showed it to my nephrologist, he wrote down the pertinent info so he can order a bunch of copies to give to his new kidney patients.

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