In 2015, the U.S. Food and Drug Administration (FDA) warned that certain type-2 diabetes medications such as Invokana® (canagliflozin) may increase patients’ risk of ketoacidosis and kidney failure, reported topclassactions.com. Diabetic ketoacidosis is a life-threatening problem that affects people with diabetes.
The FDA has approved SGLT2 inhibitors like Invokana for use with diet and exercise to lower blood sugar in adult patients with type-2 diabetes. The FDA’s Adverse Event Reporting System (FAERS), however, has indicated 20 cases of diabetic ketoacidosis, ketoacidosis or ketosis in patients treated with these drugs, resulting in hospitalization or visits to the emergency room, possibly due to side effects of Invokana.
Consumers across the country have been filing lawsuits alleging that Invokana’s makers failed to warn about serious side effects linked to the drug. These include kidney failure
, diabetic ketoacidosis, strokes and blood infections caused by urinary tract infections. Some plaintiffs also filed wrongful death claims, according to drugwatch.com
. More than 150 lawsuits are pending in Missouri and Illinois alone.
In January, a woman brought a lawsuit claiming that Invokana caused her kidney injury, and naming the drug’s manufacturers, including Janssen Pharmaceuticals, Inc., Johnson & Johnson Co. and Mitsubishi Tanabe Pharma Corp. The lawsuit contends that the kidney injury was a risk associated with Invokana that the drug makers knew or should have known at the time, alleging that they “were aware of the mechanism of action for Invokana places extraordinary strain on the kidneys and renal system.”
The Invokana lawsuit also alleges fraudulent misrepresentation, stating that product labels allegedly failed to disclose all the risks that the manufacturers knew of at the time, according to topclassactions.com. It alleges that they advertised that Invokana “was generally well tolerated and safe for use, and was not likely to cause side effects other than the ones listed – these listed side effects did not include diabetic ketoacidosis, renal injury or renal failure, bone fractures, etc.”
The drug’s manufacturers are accused of failing to adequately warn of the risk of ketoacidosis, and of failing to provide complete information to the FDA about Invokana. In addition, the drug companies cited are accused of overstating the drug’s benefits and of marketing the drug for unapproved uses, such as weight loss and lowering blood pressure.
With no Invokana verdicts or settlements to date, it remains to be seen what the courts will rule in these proliferating lawsuits.
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