April 8, 2016 — A lawsuit has been filed in Delaware by a woman who developed severe, life-threatening kidney failure after taking Invokana, a popular new diabetes drug.
She accuses Janssen Pharmaceuticals and other drug-makers of selling a dangerous medication and failing to warn about the risk of kidney failure and other severe side effects. In December 2015, the FDA issued new warnings about kidney failure as a complication of severe urinary infections.
According to the complaint, her injuries were preventable and resulted directly from drug-makers’ failure to conduct proper safety studies, failure to study alarming safety signals, suppressing information about life-threatening risks, and more.
The label on Invokana merely warns that “kidney problems” are a “possible side effect” of Invokana. In particular, the Consumer Medication Guide (PDF) fails to mention that Invokana has been associated with kidney failure.
Evidence linking Invokana and kidney failure has been growing for years. Unlike most diabetes drugs, Invokana reduces blood-sugar levels by forcing the kidneys to remove more glucose from the body in urine. Because Invokana is so new, the long-term risks of this mechanism of action are still being investigated. The problem is that diabetes itself is a risk-factor for nephropathy, a progressive kidney disease that can cause kidney failure.
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