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The Invokana Kidney Damage and Ketoacidosis Lawsuit – The Beginning is Now Officially Upon Us

Invokana (canagliflozin) is the latest in a line of drugs designed to treat Type 2 (adult-onset) diabetes. Like its predecessors, glitazone (Actos, Avandia) and sitagliptin (Januvia), it has been implicated in a number of adverse events that have resulted in patient health complications, hospitalizations and even death.

You may recognize the element “gli” in all three clinical names. This derives from the Greek word meaning “sugar.” It is the control of blood sugar, or glucose levels that all three medications attempt to achieve. In fact, they do this quite effectively. Unfortunately, due to their mechanisms of action, they affect other systems in the body as well.

Before getting into the topic of Invokana and how this and other medications attempt to control glucose levels, it is important to understand what Type 2 diabetes is – and how this differs from Type 1 (childhood-onset).

Type 1 diabetes is a congenital problem, running in families. It tends to skip generations; a Type 1 diabetic won't necessarily give birth to a diabetic child, but chances are high that his or her grandchild will suffer from the condition. In a normal person, blood glucose levels are regulated naturally through the release of insulin, a hormone produced in the pancreas. Type 1 diabetics have lost the functionality of their pancreas, and must therefore take carefully-measured insulin injections in conjunction with meals.

Type 2 diabetes presents similar symptoms, but the cause is quite different – and in the overwhelming majority of cases, highly preventable. Type 2 diabetics have a perfectly normal, functioning pancreas that produces insulin. While a few patients may have a genetic predisposition to this condition, in large part it is brought on by poor diet (particularly the overconsumption of sugary foods and commercial sodas containing high-fructose corn syrup) and a sedentary lifestyle. What has happened with these patients is that cellular receptors that interact with insulin to regulate glucose levels have become fatigued and no longer respond. This is a condition known as insulin resistance.

The purpose of glitazone drugs like Actos is to “awaken” or “reopen” these receptors in order to allow the body's own insulin to do its work. However, what happened was that in targeting these cellular receptors, glitazone created a cascade effect on genes and proteins connecting glucose regulation and other processes. One of the affected processes involved a molecule known as CDK5, which medical science has found regulates cellular growth. When this molecule is disturbed, uncontrolled cellular growth can result – in other words, cancer.

Januvia's mechanism of action was different. Instead of targeting cellular receptors, it worked to suppress or disable the action of a specific enzyme involved in the production of glucose, thereby lowering glucose levels. However, according to medical research, this particular enzyme also helps to prevent the formation of cancerous tumors. A study published in a major medical journal in 2006 reported that the risk of developing pancreatitis was twice as high among Januvia patients – thus elevating their risk of pancreatic cancer.

Invokana bypasses these cellular processes altogether and operates on glucose directly. This medication inhibits a particular protein (SGLT2), which is involved in the reabsorption of blood glucose in the kidneys.  Preventing the action of SLGT2 allows nearly 120 grams of excess glucose to be passed daily in the urine. The problem is this mechanism of action has been resulting in a number of patients developing kidney damage and diabetic ketoacidosis (DKA) (a life-threatening condition, normally associated with Type 1 diabetes, brought on by a shortage of insulin). DKA causes the body to burn fatty acids instead of glucose, which produces excess ketone bodies (molecules formed normally a result of fasting or low carbohydrate intake). In turn, this condition raises blood acidity to dangerous levels, resulting in coma and even death.

The questions that will be investigated and determined in the upcoming national Invokana lawsuits over the development of kidney damage will be whether the drug manufacturer and marketer of Invokana knew of this risk, or should have foreseen it, and whether they failed to properly warn the medical profession and consumers. While this issue likely will be the subject of great debate, it should be noted that diabetes is an expensive – and highly profitable – disease. More than 11% of Americans suffer from the disease, and 30% are at risk for developing it. Thus, the manufacturers and marketers of Invokana certainly have tremendous financial interest in fighting as long as they can.

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