Introduction

Invokana is a relatively new drug widely used for the treatment of Type 2 diabetes.  It was launched in 2013 by Janssen Pharmaceuticals and, with more than $1 Billion in annual sales, it quickly achieved to blockbuster status. It is offered as a monotherapy or in combination with metformin, Invokamet. Invokana is the first-to-market in a new class of T2D drugs called sodium glucose co-transporter 2 inhibitors.

How it's different:

By design, the mechanism of Invokana seeks to control diabetic blood sugars by interfering with critical mechanisms in the human blood supply: transport and absorption of glucose (blood sugar) and sodium. As a result, the sugar is not metabolized and is excreted through the kidneys in a population at risk for kidney disease.

Invokana's Dangerous Side Effects

Invokana has been on the market since Spring 2013 but has already stockpiled huge numbers of adverse event reports related to kidney failure and ketoacidosis.

Ketoacidosis is a condition due to starvation or uncontrolled Type I diabetes. Ketones are acid compounds that form in the blood when the body breaks down fats and proteins because it fails to metabolize nutrients systemically. Because untreated ketoacidosis can lead to death, typical cases of ketoacidosis lead to hospitalization.

On May 15, 2015, the FDA issued a Public Health Advisory linking this type of drug to diabetic ketoacidosis, a condition which can result in organ failure and death. An alarming number of FDA Adverse Event Reports also have linked this drug to kidney failure. The drug is contraindicated in patients with severe kidney impairment but is not contraindicated in patients with less than severe kidney impairment. An analysis of the FDA adverse event database shows that patients taking Invokana are several times more likely to report kidney failure than those taking non-SGLT2 diabetes drugs to Type 2 Diabetes. This likely is due to the mechanism of Invokana: rather than metabolizing blood sugar as insulin would do, it diverts the sugar through the kidneys which results in an overloaded renal capacity and, potentially, kidney failure.

The Progression of Failure

Since May 2015, Janssen has repeatedly has had to revise its warnings to include more detailed information about the risk of kidney failure and diabetic ketoacidosis associated with Invokana. Furthermore, in May 2017, the CANVAS study revealed that the risk of foot or leg amputation was nearly 300% higher when compared to other Type 2 diabetes patients.

How we can Help:

Attorney League is reviewing cases of those patients who have taken Invokana and have suffered hospitalization for ketoacidosis, kidney failure, foot or leg amputation, or death.