FDA Requires Invokana Side Effect Label Changes As Invokana Lawsuit Plaintiffs Begin To File Suit

February 25, 2016 – – TheProductLawyers.com reports on recent requirements by the U.S. Food and Drug Administration (FDA) stating that Invokana manufacturer Janssen Pharmaceuticals must change the side effects listed on the drug’s warning label to reflect urinary tract infections and diabetic ketoacidosis. This statement was issued on December 4th of 2015 and will allow the public to be more aware of two potentially life-threatening health conditions which have been allegedly linked to the drug.

Invokana is a new-generation type-2 diabetes drug which was approved by the FDA in 2013. It helps patients with type-2 diabetes to maintain their glucose (sugar) levels by stopping the kidneys from reabsorbing excess sugar and instead removing that sugar from the body via urination. To do this, it depends heavily on the kidneys, and can, therefore, have some impact on them. The drug is manufactured by Janssen Pharmaceuticals, who are a division of the well-known Johnson & Johnson Corporation.

Ketoacidosis is a serious health condition in which the body develops too much blood acid (or ketones). This can cause the patient affected to slip into a comatose state or to pass away if it remains untreated. It has been reported to develop in as little as 24 hours and can be hard to diagnose, so the FDA has asked that patients using Invokana watch carefully for symptoms which may be warning signs, including nausea and vomiting episodes, stomach pain, extreme fatigue, or difficulty breathing.

Generally, ketoacidosis can be more easily identified by significantly elevated blood sugar levels in patients. Recent statements from the FDA, however, have indicated that diabetic ketoacidosis linked to Invokana use may potentially occur without these increased blood sugar level indicators.

The FDA discussed this potential diagnosis delay, 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.”

Invokana’s label change requirements are also set to include warnings regarding urinary tract infections, a commonly reported side effect for both men and women taking the drug, and one which was noted during clinical trials. These types of infections may begin less seriously, as urinary tract infections, however, they can quickly lead to more serious and even fatal conditions if they develop into kidney or blood infections. The patients affected in this way have required hospitalization, and some required time in the ICU or dialysis treatments for kidney failure.

The attorneys of Banville Law are working to keep the public informed of this important information. They sponsor online resource website TheProductLawyers.com and are also working to help ensure that anyone who may have used SGLT2 inhibitor class drugs and who have also suffered from medical problems will have the opportunity to evaluate their legal rights in full. At this time, the attorneys of Banville Law are offering free legal consultations for affected patients, in order to assist in their pursuit of justice. These individuals may be entitled to legal action or substantial compensation.

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

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Banville Law
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