Invokana Lawsuit News And Adverse Event Reports Spur FDA’s Latest Label Warning

February 09, 2016 – – Tracey & Fox report on a recent FDA update to the labeling of diabetes drug Invokana, manufactured by Janssen Pharmaceuticals (a division of Johnson & Johnson). On December 4th of 2015, the U.S. Food and Drug Administration issued a safety communication regarding new warnings which were to be placed on all type-2 SGLT2 diabetes drugs. In this notice, the FDA indicated that patients who were taking Invokana should watch for signs of ketoacidosis, and stop taking the drug immediately and seek medical attention if any of these signals appears.

Ketoacidosis is a serious medical condition which occurs when the body has very high glucose levels. However, the FDA now warns that ketoacidosis has been associated with Invokana, and can therefore occur without these high blood sugar levels. It is generally a sign that the body is lacking insulin, and releases too much acid into the blood, which could be damaging to multiple parts of the body. Ketoacidosis symptoms include nausea and vomiting, abdominal pain, fatigue, and difficulty breathing. The FDA has been informed of 73 adverse events where patients using SGLT2 inhibitors developed ketoacidosis since March of 2013.

A statement from the FDA regarding specifics of the patients in these reports read, “All patients required hospitalization 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 ketoacidosis was delayed in some cases.”

Another health problem that the FDA noted Invokana patients should watch for is urinary tract infections. Because the drug allows the body to dispose of sugar through urine, this increase in sugar in that area can cause bacteria to develop. Patients using it are asked to watch for signs of early urinary tract infections developing, such as frequent urination, or feelings of burning and pain while urinating.

In a fact that has alarmed many current Invokana users, it has been noted that the FDA has also identified 19 cases where patients using SGLT2 inhibitors developed life-threatening infections of the blood or kidneys, some of whom even required dialysis due to outright kidney failure.

The attorneys at Tracey & Fox, who provide the Invokana resources on TheProductLawyers.com, understand how serious these possible side effects can be, and the devastating health impairments they can cause. They are aware that many patients depend on Invokana or other SGLT2 inhibitors to properly manage their type 2 diabetes. Currently, the attorneys at Tracey & Fox are working to help ensure that anyone who used these types of drugs and subsequently suffered from adverse health issues will have the opportunity to properly evaluate their legal rights. To assist anyone who wishes to seek justice, the attorneys of Tracey & Fox are offering complimentary consultations to affected individuals.

To request further information on Invokana, SGLT2 inhibitors, or to ask questions, contact the attorneys Tracey & Fox by calling 877-671-6480.

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Contact Tracey & Fox:

Sean Tracey
877-671-6480
440 Louisiana Street , Suite 1901
Houston, TX 77002

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