Invokana Lawsuit Plaintiffs Gain Support From Side Effect Warnings from European Medicines Agency

April 30, 2016 – – TheProductLawyers.com comment on alarming safety warnings recently issued to the public by the European Medicines Agency (EMA) which have allegedly linked the drug, Invokana and similar SGLT2 inhibitor class, new-generation, type-2 diabetes drugs to reported cases of more than 100 diabetic patients across the world who have developed diabetic ketoacidosis after using the medication. The EMA stated, “Although diabetic ketoacidosis is usually accompanied by high blood sugar levels, in a number of these reports, blood sugar levels were only moderately increased. These uncharacteristic blood levels could delay diagnosis and treatment.”

Diabetic ketoacidosis is an emergency physiological condition occurring when the circulatory system reaches a level of ketotic acidic toxicity. When the situation is not immediately diagnosed and alleviated, affected diabetic patients can slip into comas. The outcome can be fatal. Onset of diabetic ketoacidosis can commence within 24 hours. Diagnosis can be impaired and delayed if the key warning symptom of significantly raised blood sugar levels is absent.

When the body cannot access adequate amounts of glucose for energy production, it builds up toxic blood levels of acidic ketones which result when the body is struggling to meet all complex physiological tasks plus energy production.

Multiple lawsuits which have now been filed, as well as several FDA adverse event reports, have allegedly linked the use of Invokana use to various alarming adverse patient outcomes. In addition to diabetic ketoacidosis, clinical events include skeletal fractures, impairment of normal kidney function leading to renal failure or cardiac arrest .

The pharmaceutical action of SGLT2 inhibitor class drugs aims to balance glucose levels in type-2 diabetic patients by excreting excess blood sugar via urination. This function is heavily reliant upon adequate levels of kidney function and the absence of excess blood sugar which can trigger bacterial infection.

Recently, the U.S. Food and Drug Administration (FDA) issued a hazard alert mandating that Invokana manufacturer, Janssen Pharmaceuticals significantly and adequately alter the previous labelling attached to the drug’s packaging. This public alert was created after the FDA received multiple reports of patients who used Invokana prior to the subsequent onset of ketoacidosis. Reports made to the FDA demonstrate the necessity of emergency hospital admission for these patients including those with irreversible kidney damage and the requirement for dialysis in the advent of serious renal failure.

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

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