The number of lawsuits filed against diabetes drug Invokana manufacturer Janssen Pharmaceuticals (and parent company Johnson & Johnson) continues to increase. On March 31, 2016, a new case was filed in the Superior Court of the State of Delaware.
The plaintiff, a Tennessee resident, claims that after taking the drug, which is designed to lower blood sugar levels, she suffered serious injuries. She seeks both compensatory and punitive damages.
Plaintiff Blames Invokana for Kidney Failure and Bone Fracture
According to her complaint, the plaintiff was prescribed Invokana (canagliflozin) to treat her type 2 diabetes in December 2014. She says she took it as directed, but that while taking it, she developed kidney failure, a bone fracture, and other injuries. Because of these conditions, she had to be hospitalized for several days. She claims that she endured physical pain and suffering, emotional distress, and economic losses, including significant expenses for medical care.
Plaintiff alleges that the defendants failed to conduct proper safety studies on their drug before releasing it onto the market, that they failed to publicize “alarming safety signals,” and that they suppressed information revealing serious and life-threatening risks.
Because of the defendants’ negligence, the plaintiff claims that she and her physicians were unaware of the true nature of Invokana, or of the significant risks associated with it. She adds that the Invokana label still does not warn of the serious risks of developing bone fractures and kidney injuries.
Institute for Safe Medication Practices Sounds Alarm about Invokana and Kidney Failure
The FDA approved Invokana for the treatment of type 2 diabetes in March 2013. The drug was the first in a new class of diabetes drugs called “sodium-glucose co-transporter 2 (SGLT-2) inhibitors.” They work by stopping the kidney from absorbing glucose. As a result, the kidneys actually excrete some glucose through the urine and flush it out of the body. This action is now thought by some to put additional stress on the kidneys, particularly in those patients who are already at risk for kidney disease.
Within just two years, however, a number of reports raised concerns about the safety of the drug. On May 6, 2015, for instance, the Institute for Safe Medication Practices issued its QuarterWatch report for the 2nd quarter of 2014. In it, they stated that the drug inhibited normal kidney function, and that in its first year on the market, it was associated with a number of adverse event reports indicating serious injuries involving kidney function.
Even in the clinical trials used to gain FDA approval for the drug, it was noted that patients on the drug demonstrated reduced kidney function. Reviewers questioned what the effects might be in those patients taking the drug for a long time.
In September 2015, the FDA announced that it was requiring the manufacturers to add new warnings to the Invokana label indicating that it could increase the risk of bone fracture. “Health care professionals should consider factors that contribute to fracture risk prior to starting patients on canagliflozin,” it wrote.
On October 16, 2015, Health Canada announced that Invokana could cause acute kidney injury.
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