Last month, a New Jersey federal court consolidated approximately 55 Invokana® lawsuits and transferred them to the District of New Jersey. Invokana® lawsuits in Illinois, West Virginia, Kentucky, Virginia, Missouri, and Minnesota are now being heard by U.S. District Judge Brian R. Martinotti.
Invokana® is a prescription SGLT2 inhibitor that treats Type 2 diabetes by flushing excess sugar out of the body. A subsidiary of Johnson & Johnson, Janssen Pharmaceuticals, manufactures the drug. However, Invokana® has been linked to ketoacidosis and kidney failure, prompting the U.S. Food and Drug Administration (FDA) to issue a Drug Safety Communication.
What is Ketoacidosis?
Diabetic ketoacidosis (DKA) is a serious, life-threatening condition that results when cells in the body don’t receive the glucose they need for energy. Our bodies begin to break down muscle and fat for energy thereby producing ketones or fatty acids. When the ketones enter the bloodstream, they alter the chemical balance resulting in diabetic ketoacidosis. Ketoacidosis can be extremely painful and result in the person losing control over bodily functions.
Symptoms of ketoacidosis include:
- Excessive thirst
- Frequent urination
- Vomiting and nausea
- Abdominal pain
- Fatigue or weakness
- Shortness of breath
- Confusing
- Fruity-scented breath
- Blurred vision
- Loss of appetite
- Drowsiness
- Rapid, deep breathing
- High blood sugar
- High ketone level in the urine
Treatment complications include low blood sugar; low potassium levels that impair the function of the heart, muscle, and nerves; and, swelling in the brain. If ketoacidosis is not treated, the condition can be fatal.
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The FDA Issues Multiple Warnings
The FDA warned consumers and physicians of the increased risk of developing ketoacidosis when using Invokana® on May 15, 2015. An updated Drug Safety Communication was issued by the FDA on December 4, 2015, to revise labels on SGLT2 inhibitors to include warnings about serious urinary tract infections in addition to too much acid in the bloodstream. For some patients, the warnings are too late. For others, the damage from taking Invokana® is irreversible.
The lawsuits also allege that patients using Invokana® have developed blood clots and suffered strokes in addition to kidney damage. In 2016, the FDA identified patients who experienced serious pancreatitis while taking Invokana®. At this time, the FDA is considering whether regulatory action is required.
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