Invokana® Lawsuit Update: FDA Revises Warning Label
Invokana® belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors, which are often recommended for patients with type 2 diabetes. These types of medications work by reducing the amount of glucose that is reabsorbed in the blood and increasing the amount of glucose that is excreted by the kidneys. When combined with a healthy diet and exercise, Invokana® is intended to help patients manage their condition and avoid dangerous fluctuations in their blood glucose levels. However, an increased incidence of potentially serious complications, such as diabetic ketoacidosis, kidney failure, and heart attacks, have caused many patients to file claims in the Invokana® lawsuit. If you have been prescribed Invokana® or another diabetes medication and suffered complications, please contact an experienced pharmaceutical attorney for a complimentary case evaluation.
FDA Drug Safety Communication
In May 2016, the U.S. Food and Drug Administration (FDA) issued a safety update for Invokana® and other SGLT2 inhibitor medications. The FDA has received numerous adverse event reports concerning patients developing diabetic ketoacidosis, a buildup of acid in the blood, while taking this class of medications. Because this condition can develop very quickly and is not easily diagnosed, it commonly requires hospitalization and emergency treatment. As part of the FDA's safety update, they have also mandated that Janssen Pharmaceuticals, the maker of Invokana®, update the warning label for the drug to include specific risks of this dangerous side effect.
A History of Safety Warnings
In May 2015, the FDA issued a safety warning concerned with an increased incidence of diabetic ketoacidosis in patients who were taking Invokana®. The safety warning emphasized the danger associated with this specific class of drugs. Under normal conditions, ketoacidosis is accompanied by increased blood glucose levels that can be easily identified with simple blood tests that diabetic patients perform frequently to monitor their blood sugar. However, patients taking SGLT2 inhibitors experience higher concentrations of acid in the blood without increased blood glucose levels.
This is not the first warning label that the FDA has imposed on Invokana®. In September 2015, the packaging was revised to include warnings about the increased risk of bone fractures and reduced bone mineral density. In addition to these FDA warnings, the Institute for Safe Medication Practices has also issued several warnings over this class of drugs, specifically noting kidney impairment, dehydration, urinary tract infections, and weight fluctuations.
Contact an Experienced Attorney
If you have been injured while taking Invokana® or another similar medication, please contact an experienced pharmaceutical attorney to arrange a complimentary case evaluation.
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