Invokana Kidney Damage Risk Should Have Been Known by Drug Makers, Lawsuit Alleges

According to allegations raised in a product liability lawsuit filed against Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary, the drug makers knew or should have known about the risk of kidney damage from Invokana, a new-generation diabetes treatment that has been linked to a number of health risks in recent months.

The complaint (PDF) was filed in the U.S. District Court for the District of New Jersey on November 13, by Maria Puente and her husband, Carlos.

According to the lawsuit, Puente developed severe health complications due to side effects of Invokana, including diabetic ketoacidosis and kidney damage, indicating that she never would have used the recently introduced diabetes drug if the risks had been disclosed.

Invokana (canagliflozin) was the first member of a new class of medications introduced in March 2013, for treatment of type 2 diabetes. Known as a sodium-glucose co-transporter 2 (SGLT2) inhibitor, Invokana works in a unique way by impacting some of the normal kidney functions to increase the amount of sugar excreted in the urine. However, several critics have suggested this may cause users to face an increased risk of severe kidney damage and kidney failure.

“Defendants knew of the significant risk of kidney damage caused by ingestion of Invokana,” Puente claims in the lawsuit. “However, Defendants did not adequately and sufficiently warn consumers, including Plaintiff, or the medical community of the severity [of] such risks. To the contrary, Defendants conducted nationwide sales and marketing campaigns to promote the sale of INVOKANA and willfully deceived Plaintiff, her health care professionals, the medical community, and the general public as to the health risks and consequences of the use of the Invokana.”

Puente began taking Invokana in October 2013 and was only on the drug for about a month before she suffered her injuries.

Invokana Risks Have Emerged Over Past Year

The complaint joins a growing number of Invokana lawsuits that have been filed in recent weeks by other users of the diabetes drug, each alleging that Johnson & Johnson and Janssen withheld important safety information about the potential risks associated with their new drug.

Momentum for the litigation emerged after the FDA issued a drug safety communication in May 2015, indicating that it was investigating reports of diabetic ketoacidosis among users of Invokana and other SGLT2 inhibitors, such as Farxiga, Jardiance, Invokamet, Xigduo XR and Glyxambi.

While ketoacidosis is commonly seen among type 1 diabetics, it is not often diagnosed among individuals with type 2 diabetes, which Invokana is designed to treat. The condition involves symptoms like difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, which are caused by excessive levels of acid in the blood. Ketoacidosis often requires urgent medical treatment or hospitalization.

The same month as the FDA warnings, the Institute of Safe Medication Practices (ISMP) released a report that independently evaluated adverse event reports submitted to the FDA involving Invokana problems the first year the drug was on the marketing, identifying potential safety signals involving kidney damage that may be linked to the way Invokana and other SGLT2 inhibitors work.

The group raised questions about whether the potential risks associated with the medication may outweigh the benefits, leading some questions to be raised about whether an Invokana recall should be issued, or limitations should be placed on who receives the medication.

During the first year Invokana was on the market, ISMP highlighted 457 serious adverse event reports submitted to the FDA involving complications from Invokana. These adverse event reports typically only account for a small portion of the total problems associated with prescription medications on the market.

Many of the reported Invokana kidney problems involved kidney failure, kidney impairment or problems with kidney stones, urinary tract infections, dehydration, hypersensitivity and abnormal weight loss. Looking at reports to the FDA’s adverse event reporting system, the ISMP found that Invokana received more serious adverse event reports than 92% of the other drugs regularly monitored by the group.

In addition to lawsuits over Invokana, product liability lawyers are also investigating similar claims involving injuries associated with other diabetes drugs that are part of the same new class of medications, known as SGLT2 inhibitors, such as Invokamet lawsuits, Farxiga lawsuits, Jardiance lawsuits, Xigduo XR lawsuits and Glyxambi lawsuits. All of the medications have been aggressively marketed since they hit the market over the past two years, but Invokana remains the most widely used of the class.