Invokana Lawsuit Filings And FDA Adverse Event Reports Prompt Side Effect Warning Changes On Drug Label
February 22, 2016 – – TheProductLawyers.com reports on a safety communication issued by the U.S. Food and Drug Administration (FDA) on December 4th, 2015. The announcement discussed new label warning requirements which are to be added to type-2 diabetes medication Invokana by manufacturer Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson corporation.
This recent announcement came shortly after many adverse event reports to the FDA began to add up concerning health problems for patients who have taken Invokana and other SGLT2 class inhibitors. The new warnings specifically discuss ketoacidosis, a condition in which the body develops too much acid in the bloodstream. Ketoacidosis can be a fatal condition, and is very serious. The FDA has requested that anyone using SGLT2 inhibitors should look carefully for warning signs of ketoacidosis, including nausea and vomiting, excess fatigue, abdominal pain, or difficulty breathing.
Due to the fact that the FDA is exploring the link between diabetic ketoacidosis and Invokana, the public is discussing the potential risks of the drug more prevalently. Diabetic ketoacidosis has been found to potentially occur without heightened blood sugar levels, it has been noted that patients developing this condition may be difficult to diagnose quickly. It was indicated that, in further details of all the adverse event reports, “All patients required hospitalization or treatment in an emergency department. In many cases, ketoacidosis was not immediately recognized because the blood glucose levels were below those typically expected for diabetic ketoacidosis. As a result, treatment of the ketoacidosis was delayed in some cases.” Ketoacidosis can put patients into a comatose state or cause death within as little as 24 hours if left untreated.
Invokana has been linked to other health problems as well, in adverse event reports, the drug has been connected to urinary tract infections, which can lead to severe kidney and blood infections. The FDA has requested that patients taking the drug also be aware of any burning or pain during urination, in addition to other common urinary tract infection symptoms. Other severe conditions which developed from these UTIs were reported to the FDA as well. In 19 reported cases, patients actually developed life-threatening blood and kidney infections, some of which required ICU treatment and dialysis.
The attorneys of Banville Law are now working to provide the general public with current information on the potential side effect risks which have been associated with Invokana, as well as Invokana lawsuit information. They sponsor an online Invokana resource website at TheProductLawyers.com, and are working hard to ensure that people who have used Invokana or other SGLT2-class inhibitor drugs and who also suffered from health problems will be given the important opportunity to investigate their legal rights fully. To help encourage those affected to pursue justice, the attorneys of Banville Law now offer free legal consultations.
To request additional Invokana information, or to ask questions, please contact Banville Law by calling 877-671-6480.
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