Philadelphia, PAOn December 4, the US Food and Drug Administration (FDA) posted to its website a warning with regard to diabetes drugs in the SGLT2 inhibitor class. The concern is the emergence of diabetic ketoacidosis in individuals with type 2 diabetes. Invokana is one of the drugs tagged by the FDA to include warnings about the potential for the life-threatening condition, amongst other Invokana adverse reactions.
Within days of the FDA posting its warning and mandating Janssen Pharmaceuticals and other manufacturers to include warnings for type 2 diabetics, Arthur Portnoff had filed his Invokana side effects lawsuit. Portnoff, who now resides in Texas but lived in Philadelphia when he used Invokana, filed his lawsuit in the Philadelphia Court of Common Pleas.
Invokana, manufactured by Janssen, is already linked with cardiovascular and kidney failure, amongst other Invokana adverse events. Diabetic ketoacidosis is something new, in that it normally affects individuals with type 1 diabetes. The fact that it has begun to emerge in patients with type 2 diabetes is enough of a concern for the FDA to mandate a warning on all diabetes drugs in the SGLT2 class.
Invokana (canagliflozin) is one of them. Invokamet is too. Both are made by Janssen, a unit of pharmaceutical giant Johnson & Johnson.
In his Invokana side effects lawsuit, Portnoff noted that he had begun using Invokana for his type 2 diabetes in November 2014. Within three months, or so his lawsuit claims, he developed diabetic ketoacidosis and was hospitalized. Portnoff asserts that Janssen brought Invokana to market without conducting sufficient studies to assure its safety to patients. Not only does Portnoff accuse Janssen of not alerting consumers to the risk, he also accuses Janssen of withholding information about the risk for diabetic ketoacidosis and Invokana adverse events from regulators.
“Defendants withheld material information from the FDA and misrepresented material information regarding the risks and benefits of Invokana in its communications with the FDA,” Portnoff said in his complaint.
Invokana and Invokamet (canagliflozin/metformin) had previously been the subject of an FDA alert this past September, with regard to concerns over decreased bone density and the potential for bone fractures resulting from reduced bone density.
Then, in December, the FDA was back with mandated warnings for blood problems and urinary tract infections, as well as risk for diabetic ketoacidosis. The latter raises the levels of blood acids known medically as ketones, which are toxic and can cause nausea, vomiting, abdominal pain, tiredness and breathing problems. In rare cases, it can be fatal.
Janssen has indicated it stands behind it products and will aggressively fight the lawsuit. Portnoff filed his Invokana adverse effects lawsuit December 10 in Philadelphia.
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