Invokana Lawsuit Plaintiffs Find Support Through EMA Side Effect Warnings

May 01, 2016 – – TheProductLawyers.com reports on allegations arising from several lawsuits and multiple complaints to the FDA which link Invokana, a medication used by diabetic patients to a variety of adverse clinical events. These included bone fractures, heart attacks, kidney damage and ketoacidosis.

Prior to product safety alerts from the European Medicines Agency (EMA), globally, there was an unexpected occurrence of diabetic acidosis in over 100 patients who had developed the condition following use of Invokana and other new-generation type-2 diabetes medications belonging to the SGLT2 inhibitor class. A statement made by the EMA noted, “Although diabetic ketoacidosis is usually accompanied by unusually elevated blood sugar levels, in a number of these reports, blood sugar levels were only moderately increased. These uncharacteristic blood level results could delay diagnosis and treatment.”

Upon receipt of several reports alleging that patients who had used Invokana and subsequently developed ketoacidosis, the U.S. Food and Drug Administration (FDA) issued a safety warning requiring that Invokana manufacturer, Janssen Pharmaceuticals appropriately change the previous labelling on the product. Alarming reports indicate that all of these affected patients needed hospitalization with some requiring renal dialysis for kidney failure.

Diabetic ketoacidosis is an emergency renal condition where the patient’s body retains excess acids in the bloodstream at a toxic level. Onset of the deadly condition can occur within less than 24 hours and undiagnosed and untreated, it can result in coma or even death. The absence of clinical warning signs such as heightened blood sugar level readings can delay diagnosis and the commencement of crucial treatment options. The body requires glucose to produce energy for activity. When glucose levels are insufficient, the body resorts to utilizing stored fat. This results in the production of ketones at toxic levels.

SGLT2 inhibitor medications work to balance glucose levels in diabetic patients by removing excess glucose, or sugar, from the body through urination. This process depends heavily upon kidney function and increased stress may result in damage to the organs.

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

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