March 13, 2016 — Janssen Pharmaceuticals is facing a growing number of lawsuits involving plaintiffs who developed kidney failure after taking Invokana.
One lawsuit (PDF) was filed on February 19 by Rose Adye, a woman from Kentucky. She started taking Invokana in November 2014 and was hospitalized for kidney failure in February 2015.
Another lawsuit (PDF) was filed on February 29 by Loris Furlow, a woman from California who started taking Invokana in April 2014. In March 2015, she was hospitalized due to acute kidney injury and kidney failure. According to her complaint:
“Invokana is unreasonably dangerous and defective as formulated, putting consumers, including Plaintiff, at an unreasonable risk of suffering injury and death.”
Janssen is accused of inadequately warning about kidney failure, stating only that a “possible side effect” of Invokana is “kidney problems.” Lawyers say Janssen merely indicated that there was a risk for kidney problems, without addressing the specific increased risk of kidney failure or the extent of that risk associated with Invokana.
When Invokana (canagliflozin) was approved in March 2013, it was the first drug in the SGLT2 inhibitor class. These drugs rely on the kidneys to control blood-sugar levels, which is one reason why they are not recommended for patients with serious kidney problems.
In December 2015, the FDA warned about urinary infections spreading to the kidneys and causing kidney failure. Because urinary infections occur in at least 5% of patients, lawyers say Janssen should have anticipated an increased risk of kidney failure.
Kidney impairment is also a potential complication of dehydration, another common side effect that occurs when patients urinate excessively. Patients who are severely dehydrated can develop ketoacidosis (too much acid in the blood) within a few hours, even when blood-sugar levels are normal or only slightly elevated.
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