Elevated Rates of Kidney Failure Among Invokana® Patients

Invokana® Kidney Complications

Many patients with type 2 diabetes are prescribed medications that help maintain blood glucose levels within a normal range. Many of these medications work by increasing the body’s receptivity to insulin or by stimulating the pancreas to produce more of the hormone. Invokana®, like other SGLT2 inhibitors, work by preventing glucose from being reabsorbed into the bloodstream and instead excreted through the urine.

Within the first year after Invokana® was approved by the U.S. Food and Drug Administration (FDA), there were 450 reports of serious adverse patient events, including 54 complaints of kidney failure. In December 2015, the FDA revised the labels of SGLT2 inhibitor medications to include warnings about potential complications, specifically diabetic ketoacidosis and serious urinary tract infections (UTIs). Kidney failure is a potential complication of both UTIs and diabetic ketoacidosis.

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The nonprofit Institute for Safe Medication Practices (ISMP) has also issued warnings about Invokana® and other SGLT2 inhibitors. They noted an increase in kidney failure or impairment, kidney stones, UTIs, and abnormal weight loss. The ISMP reported in January 2016 that the count of adverse events associated with Invokana® had risen to 5,484. In addition to ketoacidosis and kidney problems, plaintiffs in lawsuits against Janssen Pharmaceuticals, the manufacturer of Invokana®, have also claimed cardiovascular complications and strokes.

Kidney Failure

The kidneys are responsible for filtering waste products from the blood. When the organs cease this function, they are said to be in failure. Acute renal failure can develop rapidly over a few hours or may take several days to progress. The symptoms may be subtle or even nonexistent until the patient becomes suddenly quite ill. The condition can be fatal without treatment. Dangerous levels of waste products can accumulate, along with fluids and electrolytes, which causes an imbalance in the chemical makeup of the blood.

There are many common symptoms of acute kidney failure, including:

• Decreased urine output
• Fluid retention
• Drowsiness
• Fatigue and weakness
• Confusion
• Nausea
• Chest pain
• Shortness of breath
• Abnormal heart rhythms
• Seizures

Kidney failure requires immediate medical intervention to prevent permanent damage. Complete kidney failure may require long-term dialysis, which must be administered several times a week to keep waste and fluid levels stable. For more advanced cases, some patients may need a kidney transplant to regain function.

Renal failure can also cause a number of other adverse conditions for patients. Pulmonary edema, or a buildup of fluid in the lungs, can deprive the body of oxygen. Treatment commonly requires assisted mechanical ventilation and intravenous (IV) medication to eliminate the buildup.

Another potential complication of kidney failure is pericarditis, an inflammation of the lining of the heart. Pericarditis can be treated with medication, but severe cases may trigger a more serious heart complication called cardiac tamponade, which can be life threatening.

Pending Lawsuits

Initial court cases related to Invokana® and Invokamet® were filed in September 2015. The first case came from Canada, filed by a woman who took Invokana® for eight months. Upon hearing a report about risks associated with the drug, the plaintiff made an immediate appointment with her doctor, who subsequently diagnosed her as being in the initial stages of kidney failure. A class action lawsuit is now pending in Canada, with dozens of claimants seeking compensation of over one billion Canadian dollars.

In the United States, multiple claims have been filed holding Janssen Pharmaceuticals accountable for claims of negligence, failure to warn, fraudulent misrepresentation, and strict liability for manufacturing a defective drug.

In the United States, multiple claims have been filed holding Janssen Pharmaceuticals accountable for claims of negligence, failure to warn, fraudulent misrepresentation, and strict liability for manufacturing a defective drug. Plaintiffs commonly state that if they had understood the risks associated with Invokana®, they would have substituted a different method for controlling blood sugar, or their doctor would have more closely monitored them to avoid complications.

One claim was filed by a female patient on February 29, 2016, in California. She was hospitalized with acute kidney injury and kidney failure after taking Invokana®. Her civil complaint states that warning labels for Invokana® do not adequately address risks of kidney failure risks to patients. The label mentions kidney problems as a possible side effect but does not mention the possibility of failure.

FDA Approval

In initial FDA meetings regarding the potential approval of Invokana®, questions were raised as to whether the benefits of the drug outweigh its potential risks. Preliminary studies had shown several risks that concerned some of the doctors on the panel, including cardiovascular events and strokes. Although 10 panel members ultimately voted to approve Invokana® in 2013, five voted against it. The FDA ordered Janssen to conduct several post-marketing safety studies, which are currently ongoing.

Multidistrict Litigation

It is anticipated that Invokana® lawsuits may be consolidated under multidistrict litigation (MDL). MDL is common in pharmaceutical liability lawsuits when multiple plaintiffs file claims against the same defendant. MDL can expedite the evidence discovery process, but still allows individuals to retain their own legal counsel and receive a separate settlement reflecting their injuries. This differs from class action lawsuits, where the outcome of a small group of plaintiffs is legally binding on the larger group.

Contact an Experienced Pharmaceutical Lawyer

In 2014, $19.8 million was spent to market Invokana® to doctors, and the new SGLT2 inhibitor became a blockbuster profit generator for Janssen and their parent company Johnson & Johnson. The drug and Invokamet®, which combines canagliflozin with the diabetes medication metformin, brought in $278 million during the first quarter of 2015 alone. Invokana®’s website currently counts “over 7 million prescriptions…and growing.”

If you or a member of your family has been affected by complications from Invokana®, Invokamet®, or another SGLT2 inhibitor medication, you may qualify for compensation. Please contact our legal team to schedule a complimentary case evaluation.