Invokana Plagued by New FDA Warnings and Lawsuits


July 20, 2016

Invokana Plagued by New FDA Warnings and Lawsuits

When it was first announced—with the help of aggressive marketing—Invokana was hailed as an exciting development in the world of diabetes treatment and the first of a promising new generation of diabetes drugs. A string of increasing safety warnings and a series of lawsuits on the diabetes medication, however, have led to concern over the serious health risks associated with taking the drug.

Invokana is an oral medication for type 2 diabetes that falls into the category of drugs known as SGLT2 inhibitors. The medication works by aiding the kidneys in removing sugar from the bloodstream through the urine. It is not recommended for anyone except type 2 diabetes patients, who typically take it once a day. For some diabetes patients, Invokana is combined with metformin hydrochloride (Glucophage) to form a drug that is prescribed under the name Invokamet.

Approved three years ago, the concerns over Invokana trace back to the same time, with some members of an FDA advisory panel on the drug raising issue with the potential heart health risks. Since then, more concerns regarding side effects have led the FDA to issue multiple Invokana warnings.

In December of 2015, the FDA revised the labeling of SGLT2 inhibitors, such as Invokana, to include the risks of both too much acid in the blood (ketoacidosis) and serious urinary tract infections. Both conditions can lead to hospitalization.

The FDA began by issuing a Drug Safety Communication in May of the same year that warned of the risk of ketoacidosis and alerted the public that they would be evaluating the issue. Of the ketoacidosis cases, the FDA identified in type 1 and 2 diabetes patients using SGLT2 in the following months, all needed hospitalization or treatment in an emergency department.

They also discovered multiple cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that required hospitalization and even intensive care unit admission.

Then, in May of this year, the FDA issued another Drug Safety Communication after a shocking interim clinical trial found an increase in leg and foot amputations (mostly affecting the toes) with patients using Invokana and Inovkamet.

The trial is ongoing, and the FDA has not yet determined if the drugs increase the risk of leg and foot amputations, but the trial’s current findings indicate twice as many leg and foot amputations in patients using Invokana and Invokamet compared to patients given a placebo. Following the trial findings, the European Medicines Agency (EMA) also began a review of Invokana.

Adding even further fuel to the fire, last month the FDA strengthened Invokana kidney failure warnings (as well as Invokamet and dapagliflozin). The strengthened warning, which will appear on the medications’ labels, advises patients using the drugs about the risk of acute renal failure and came after a 32-month period during which the FDA received reports of 101 confirmable cases of acute kidney injury.

In about half of the cases, the acute kidney injury occurred within only a month of taking the medications. Most patients who encountered acute kidney injury while taking Invokana improved when they stopped taking the drug.

Because the acute renal failure injury cases used to create the ruling were only those reported to the FDA, the agency posits that there are likely more cases of which they are unaware.

Invokana is distributed by Janssen Pharmaceuticals, Inc., which is a subsidiary of Johnson and Johnson, and they are now facing numerous lawsuits from patients who have experienced the adverse effects of the drug.

"Our lawyers are evaluating a possible Invokana lawsuit for patients who have been affected by ketoacidosis, renal failure or kidney problems after taking Invokana."
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Invokana Ketoacidosis And Kidney Failure Lawsuit - Lawyer 4 Lawsuit

If you have taken Invokana and have experienced Ketoacidosis or Kidney Failure contact Invokana lawyer for free case evaluation today.

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The lawsuits filed against Janssen Pharmaceuticals, Inc. (along with Johnson & Johnson and Mitsubishi Tanabe Pharma Corp.) encompass a range of complaints, with many patients seeking damages after developing diabetic ketoacidosis, chronic kidney disease, and/or suffering from strokes.

There is even a wrongful death lawsuit against Janssen, filed by the family of a Louisiana woman who experienced diabetic ketoacidosis, severe kidney damage, a heart attack, a stroke and eventual death while on Invokana (Jackson v. Janssen Pharmaceuticals et al., case number 3:16-cv-00319, in the U.S. District Court, Middle District of Louisiana).

Most of the plaintiffs who have filed lawsuits against Janssen Pharmaceuticals, Inc., Johnson & Johnson and Mitsubishi Tanabe Pharma Corp. allege that the companies were aware of the health risks of Invokana, but continued to promote it to the public.

While litigation is still in early stages, new lawsuits continue to be filed, casting more attention to the serious safety concerns regarding the medication. The FDA continues to study Invokana and the adverse effects linked to it.

Publisher: Salient News