FDA Discusses New Label Changes As Invokana Lawsuit Plaintiffs Discuss Drug’s Alleged Side Effects

March 09, 2016 – – TheProductLawyers.com reports on new label-change requirements for Invokana manufacturer Janssen Pharmaceuticals by the U.S. Food and Drug Administration (FDA). The new FDA stipulations state that Janssen Pharmaceuticals (a subdivision of Johnson & Johnson) is required to make necessary changes to the side effects and warnings currently listed on the drug’s label to reflect both urinary tract infections and diabetic ketoacidosis. This FDA announcement was made on December 4th of 2015 and is designed to provide the public with a greater awareness of two potentially life-threatening complications which were linked to the drug in several FDA adverse event reports, as well as during clinical studies.

Invokana is a new-generation, type-2 diabetes drug which gained FDA approval in 2013. It was launched as the first of a group of drugs within its class referred to as SGLT2 class inhibitors. Invokana works to assist patients with type-2 diabetes in maintaining their blood sugar levels by preventing the kidneys from once again absorbing extra sugar and instead getting rid of that sugar (glucose) through urination. To accomplish this, the drug relies heavily on the kidneys, and can therefore substantially stress them.

Diabetic ketoacidosis (DKA) is a very dangerous health condition, and takes place when the body develops a surplus of toxic acid (or ketones) in its bloodstream. This can cause patients to become comatose or even die if they do not receive proper and prompt treatment. It is noted to potentially develop in as little as 24 hours and can prove difficult to diagnose, so the FDA instructed patients taking Invokana to watch closely for symptoms and warning signs. According to the FDA, these signs and symptoms could include nausea and vomiting, stomach pain, excess fatigue, or difficulty breathing.

Diabetic ketoacidosis in Invokana patients can be much less easily identified than usual metabolic acidosis, which usually gives off red flags in patients by showing significantly elevated blood sugar levels. The FDA discussed this potential diagnosing difficulty by stating, “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.”

At this time, the attorneys of Banville Law are dedicated to keeping the public fully informed of any important information surrounding Invokana. They sponsor an online resource website at TheProductLawyers.com, and are also assisting anyone who may have taken Invokana and suffered from medical problems. They want to ensure that these individuals will be given the important opportunity to investigate their legal rights fully. Currently, to better assist those wishing to pursue justice, the attorneys of Banville Law are offering complimentary legal consultations for affected parties. These patients could be entitled to significant compensation.

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

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