TheProductLawyers.com announces a lawsuit against Janssen Pharmaceuticals which has been filed under case number 1:15-cv-00636 in the Southern District of Alabama. The plaintiff alleges that after her use of Invokana she developed diabetic ketoacidosis, a life-threatening condition related to too much acid in the bloodstream. According to the plaintiff she began taking the drug in December 2014 and very shortly thereafter was diagnosed with ketoacidosis.
Within the complaint documents, the plaintiff claims that she was never made aware of a potential for developing ketoacidosis and that Janssen Pharmaceuticals was negligent in failing to inform consumers of this potential side effect. According to her complaint, in addition to the company’s failure to inform consumers she alleges they should have been made aware of it the potential side effects through the process of their drug trials. She likewise claims that the drug has been marketed “off-label” to patients suffering with high blood pressure and type I diabetes, which is a use that has not been approved by the FDA. This, she claims, is negligence on the part of Janssen Pharmaceuticals as well.
Ketoacidosis requires immediate attention as it can come on very suddenly, within 24 hours or less, and patients who are not treated immediately could fall into a coma and even die. With the primary risk group for this condition being diabetic patients, it is important to monitor for the condition at all times. After numerous adverse event reports related to diabetic ketoacidosis and Invokana the FDA has required Janssen Pharmaceuticals to amend the warning label on the drug to include possible development of ketoacidosis.
The FDA states that all patients taking Invokana, or any other SGLT2 inhibitor, should be on the lookout for symptoms of ketoacidosis. These can include nausea and vomiting, confusion, shortness of breath, excessive thirst, abdominal pain or frequent urination. These symptoms may present with or without the traditional indicator of high blood sugar that is characteristic of ketoacidosis which could delay essential treatment.
For more information about the Invokana lawsuits, or this press release, please contact TheProductLawyers.com on 888-997-3792.
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