Invokana Lawsuit – Plaintiffs Display Dangerous Side Effects After FDA Safety Warning

April 20, 2016 – – TheProductLawyers.com reports on two lawsuits which have been filed against Janssen Pharmaceuticals (a division of Johnson & Johnson), regarding their type-2 diabetes drug, Invokana. This particular drug is a new generation of diabetes treatment along with several other drugs classed as SGLT2 inhibitors. The plaintiffs who have filed the recent lawsuits may be just the first of many actions brought against the manufacturer of the drug. A predominant allegation raised is that using Invokana was responsible for the subsequent development of the serious and potentially fatal metabolic condition, diabetic ketoacidosis.

One of the initial lawsuits filed against the Invokana manufacturers took place on December 15th, 2015. This complaint was filed under case number 1:15-cv-00636 in the U.S. District Court for the Southern District of Alabama. Details within the suit state that the plaintiff who started to take Invokana in December 2014 quickly developed diabetic ketoacidosis. This plaintiff claims that the drug’s manufacturers neglected to adequately inform her of this deadly risk and that they have likewise neglected to do this with other consumers from all across the nation.

She claims that manufacturer Janssen was negligent in not clearly warning potential patients about the possible adverse risks and side effects of their drug. She also claims that the company neglected to adequately undertake studies of these potential risks and additionally, after gaining approval from the U.S. Food and Drug Administration to market the drug as a type-2 diabetes medication, they recklessly went on to market it “off-label” as well as a type-1 diabetes treatment. “Off-label” marketing is a term used when a drug manufacturer advertises their drug for uses other than those which have been previously approved by the FDA.

Another lawsuit involving similar claims was filed by a plaintiff in Philadelphia, Pennsylvania in the Court of Common Pleas. This complaint is listed under case number 15-12-00653 and was filed on December 10, 2015. The male plaintiff in this case began using Invokana in November of 2014. He alleges that after only 3 months of using the drug, he was diagnosed with diabetic ketoacidosis.

Invokana and diabetic ketoacidosis were also the focus of a recent safety communication issued by the FDA concerning Invokana and ketoacidosis. The FDA’s warning required manufacturer Janssen Pharmaceuticals to make changes to the product’s labelling in order to clearly warn consumers regarding the risks of ketoacidosis and urinary tract infections.

Diabetic ketoacidosis is a potentially fatal outcome. The new warning has created an urgency to generate greater public awareness of the possible health risks. Ketoacidosis can develop in less than 24-hours and untreated, results in coma or death.

The FDA is warning that patients taking Invokana should monitor themselves carefully for clinical indicators of impending ketoacidosis. These include nausea and vomiting, abdominal pain, difficulty breathing, and fatigue.

For more information about the Invokana lawsuits, or this press release, please contact TheProductLawyers.com on 888-997-3792.

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