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19
Nov

Is Janssen Pharmaceutica Looking For New Markets For the Diabetes Drug Invokana, Despite Alleged Dangers and Lawsuits?

Invokana (canagliflozin) has been implicated in elevated risks of diabetic ketoacidosis (dangerous blood acidity), kidney failure, and more recently, osteoporosis (loss of bone density). Lawsuits involving Invokana against drug manufacturer Janssen allege that company executives were aware of these dangers and failed to warn consumers and the medical community. Despite this, Janssen, in its quest to expand the market for Invokana and maximize profits regardless of the human cost, is apparently exploring the possibility of selling the drug for the treatment of additional disorders – including weight loss and Type 1 diabetes.

It is important to understand that Type 1 diabetes is a different disorder from the Type 2 variety that Invokana was designed to treat. Type 1 diabetes runs in families; it is a genetic condition. Those who suffer from Type 1 diabetes (also known as “childhood onset”) are born with a non-functioning pancreas, the organ that produces insulin. Type 2 diabetics have a normal pancreas that does produce insulin; however, due to various factors the body’s cells have developed insulin resistance. As a result, excess glucose (blood sugar) builds up in the system.

Invokana’s mechanism of action causes the kidneys to reabsorb up to 90% of excess glucose, which is passed through the urine. While initially hailed as a “miracle drug,” prominent physicians expressed serious doubts about Invokana’s safety as well as some aspects of the clinical testing (CANVAS) prior to its approval for the market. Of particular concern was the connection between Invokana and the formation of blood clots, which put patients at an elevated risk for heart attack and stroke.

Levin Papantonio attorney Tim O’Brien, who has consulted with medical experts in anticipation of litigation over Invokana, said, “With so many cardiovascular events occurring so soon after the commencement of Invokana therapy in the CANVAS trial, it is [our] opinion that this drug will end up causing unnecessary heart attacks and taking lives.”

Nonetheless, the FDA went ahead and granted approval in 2013, stating that Invokana’s benefits (particularly to Janssen’s bottom line) outweighed the risks. This approval was granted on the condition that Janssen would monitor its own product and conduct “post-market” studies in order to determine how many patients wound up suffering cardiac events as a result of taking Invokana – essentially putting the foxes in charge of the hen house for four years.

Since then, Invokana has been implicated in elevated risk of ketoacidosis and osteoporosis as well.

Since Type 2 diabetes is often linked to obesity, and obesity has also become epidemic, researchers have been exploring the possibility using diabetic medications as a weight loss treatment. A recent study, published in the research journal Obesity, concluded that “In overweight and obese subjects without diabetes mellitus, canagliflozin [Invokana] significantly reduced body weight compared with placebo and was generally well tolerated.” However, all three researchers have disclosed significant financial ties to drug maker Janssen. One is actually a Janssen employee.

Another study has been exploring the use of Invokana for the treatment of Type 1 diabetes. Although “childhood onset” diabetes is quite different from the Type 2 variety in terms of causes, the symptoms can be virtually identical due to the build-up of excess glucose in the system. This particular study, carried out at the Veterans San Diego Administration Healthcare System and the University of California, studied the effects on over 350 test subjects, all of whom took daily insulin injections. The researchers concluded that:

The insulin-dependent mechanism of action of canagliflozin [Invokana] offers a unique benefit profile in patients with type 1 diabetes, which is different from that of standard insulin therapies that are associated with hypoglycemia and weight gain.

The study was published in a recent issue of Diabetic Care. However, only a year and a half ago, Janssen’s own advertisements in journals such as Modern Medicine warned that “Invokana® isnot recommended in patients with type 1 diabetes” (emphasis added).  Furthermore,Diabetology.com, a website that reported on the San Diego study, warns that Invokana “is a relatively new drug; its long-term effects are not yet well established” –  and the  elevated risk of ketoacidosis remains.

As of this writing, Invokana has not yet received FDA approval for weight loss or the treatment of Type 1 diabetes. A licensed physician may write an off-label prescription if, in his or her professional judgment, it may help the patient. However, legally, Janssen may not advertise Invokana for anything other than what has been approved by the FDA.