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On April 22, 2016, a couple from Illinois filed an Invokana lawsuit in the District of New Jersey, Trenton Division. They named manufacturers Janssen Pharmaceuticals and parent company Johnson & Johnson (J&J) as defendants.

This is one of many cases that have been filed concerning the potential side effects of Invokana, which can include kidney stones, kidney impairment, urinary tract infections, and diabetic ketoacidosis (DKA). Plaintiffs allege that the manufacturer did not provide adequate warnings about the risks associated with the type 2 diabetes drug, and failed to perform appropriate clinical trials on the drug before releasing it on the market.

Plaintiff Takes Invokana and Suffers from a Stroke

In this particular case, the plaintiff started taking Invokana (canagliflozin) in October 2015 to help treat her diabetes. The FDA approved Invokana in March 2013, the first in a new class of diabetes drugs called “sodium-glucose co-transporter 2 (SGLT-2) inhibitors.” These drugs stop the kidney from absorbing glucose, which increases the amount of glucose that the kidneys excrete through urine, reducing overall blood glucose levels in diabetes patients.

The plaintiff states that she used the drug as directed, and relied on claims made by the defendants that the drug was safe and effective. After starting treatment with Invokana, though, she suffered a stroke within just a few weeks. Had she known about the risks, the plaintiff says she would never have used Invokana, and would have chosen a safer alternative.

Early Studies Suggested Risk for Invokana Stroke

Most of the side effects associated with Invokana so far have been those affecting the kidneys and the blood, such as DKA. But could the drug also increase the risk of blood clots and stroke, such as what occurred in this case?

Back when the drug was first approved in 2013, FDA advisory committee members were actually concerned about this possibility. According to Medscape, two of the cardiology members of that panel expressed concern about cardiovascular safety with Invokana. As a condition of its approval, the FDA required the manufacturers to perform five separate postmarketing studies.

Among these was the completion of the ongoing cardiovascular outcomes trial called “Canagliflozin Cardiovascular Assessment Study (CANVAS),” which the company was already working on at the time of the drug’s approval.

Even in 2013, data from CANVAS showed a 46 percent elevated risk for stroke within the first 30 days of treatment. One of the cardiologists on the panel voted against FDA approval for Invokana, because of his concerns about the cardiovascular risks.

With respect to the trial cited by the FDA reviewer, the FDA concluded that “any imbalance in results during the first 30 days or the trial” in question “may be attributable to chance or may have been caused by an early increase in the risk of MACE [major adverse cardiovascular events]-plus associated with canagliflozin among subjects with high background cardiovascular risk.” The FDA went on to note that “There was no evidence of an increased risk of MACE-plus associated with canagliflozin after 30 days” in the trial.

Plaintiff Seeks in Excess of $75,000 in Damages

The plaintiff in this case brings counts of manufacturing defect, defective design, failure to warn, breach of warranties, negligence, fraudulent and negligent misrepresentation, fraudulent concealment, and fraud. The couple seeks both compensatory and punitive damages, in excess of $75,000.

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