Kidney Failure, Ketoacidosis Lawsuit Filed Over Invokana Diabetes Drug

While Johnson & Johnson’s Janssen Pharmaceuticals subsidiary continues to aggressively promote use of their new-generation diabetes drug, a product liability lawsuit filed last week indicates that a Maryland man suffered diabetic ketoacidosis and kidney failure from side effects of Invokana.

The complaint (PDF) was filed by John V. Markowski in the U.S. District Court for the District of New Jersey on November 15, indicating that the drug maker has failed to adequately warn consumers and the medical community about the serious health risks associated with the diabetes drug.

Invokana is part of a new class of treatments, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work in a different way from other diabetes treatments, impacting the normal kidney functions to increase the amount of sugar excreted in the urine. Invokana was the first member of this new class to hit the market, introduced in early 2013 and aggressively marketed to consumers and doctors as a superior new type of treatment. However, as more individuals have switched to the drug, a steady stream of serious side effects have emerged.

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Markowski indicates that he began to use Invokana in September 2013, and only a few months later began to suffer diabetic ketoacidosis and kidney failure, resulting in hospitalization.

“Plaintiff agreed to initiate treatment with invokana in an effort to reduce his blood-glucose, and because he was misled by Defendants into believing Invokana possesses indications or benefits which it does not,” the lawsuit states. “Instead of being safe and effective as Invokana’s alternatives are, Invokana can cause severe injuries, such as those suffered by Plaintiff, and Invokana has not been approved nor deemed safe and effective for either weight loss or reducing blood pressure, as Defendants represent.”

The case joins a growing number of similar Invokana lawsuits filed in recent months, including claims by other individuals who developed diabetic ketoacidosis, kidney failure, heart attacks and other injuries.

Invokana diabetic ketoacidosis problems can cause low blood sugar, low potassium levels that can interfere with the functioning of the heart, muscles and nervous system, and can also cause swelling of the brain. If left untreated, ketoacidosis can result in loss of consciousness and even death.

In December 2015, the FDA required Johnson & Johnson and the makers of other SGLT2 inhibitors to add new diabetic ketoacidosis warnings to their medications, urging users to stop taking the drug and seek immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.

In May 2015, the Institute for Safe Medication Practices (ISMP) conducted a detailed review of adverse event reports submitted to the FDA during the first year Invokana was on the market, and identified a potential risk of kidney damage with Invokana and other SGLT2 inhibitors, raising questions about whether the benefits provided by the medication justify the risk.

In June 2016, the FDA required the drug makers to add new Invokana safety warning, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.

As Invokana injury lawyers continue to review and file claims for individuals nationwide, it is widely expected that hundreds, if not thousands, of additional lawsuits may be filed in the coming months and years.


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