Invokana Lawsuit And Adverse Event Reports Spur FDA To Require Side Effect Warning Changes on Drug Label

February 11, 2016 – – TheProductLawyers.com reports on a December 4th, 2015 safety communication issued by the U.S. Food and Drug Administration regarding the requirement of new label warnings to be added to type 2 diabetes drugs in SGLT2 inhibitor classes, including Invokana.

This announcement followed many reports of adverse events occurring in patients who have used the drugs. The new warnings concern a condition called ketoacidosis, in which the body has too much acid in its bloodstream. Ketoacidosis can be extremely serious or even fatal. The FDA has asked that anyone taking SGLT2 inhibitors to watch closely for signs of ketoacidosis, including nausea and vomiting, fatigue, abdominal pain, or difficulty breathing.

Because the FDA has determined that diabetic ketoacidosis linked to Invokana can occur without significantly heightened blood sugar levels, it has been indicated that patients suffering from the condition may be more difficult to initially diagnose. They discussed specifics of adverse event reports they had received which indicated that, “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.”

Invokana has also been linked to urinary tract infections, which can lead to serious kidney and blood infections. The FDA has asked that patients using the drug be aware of any burning or pain during urination, in addition to other UTI symptoms. Conditions spurred from urinary tract infections were also reported to the FDA. In 19 of these cases, the patients had developed life-threatening blood infections and kidney infections.

At this time, the attorneys of Banville Law are working to provide the general public with up to date information on the potential risks associated with Invokana, as well as product lawsuits relating to the drug. They sponsor an online Invokana resource at TheProductLawyers.com, and are working to ensure that people who have used SGLT2 inhibitor drugs and who later suffered from adverse health effects will be given opportunity of fully investigating their legal rights. To help facilitate this process, the attorneys at Banville Law offer complimentary legal consultations to affected individuals at this time.

To ask questions or request additional Invokana information, please contact Banville Law by calling 877-671-6480.

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Contact TheProductLawyers.com:

Banville Law
877-671-6480
info@banvillelaw.com
165 West End Ave #1h,
New York, NY 10023

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