A new lawsuit has been filed against the makers of diabetes drug Invokana claiming the drug causes severe kidney damage.

Plaintiff Judith B. says she took Invokana from January 2015 through March 2015 as it was prescribed to control her blood sugar.

Known generically as canagliflozin, the medication makes the kidneys remove sugar from the body through the urine rather than have it be reabsorbed into the blood.

Invokana, a Johnson & Johnson product, is used to control blood sugar levels in adults with type-2 diabetes.

Invokana works through the kidneys. The medication’s own warnings state “renal function abnormalities can occur after initiation.”

Invokana Linked to Severe Kidney Damage

Invokana was FDA-approved in 2013 to help maintain blood sugar levels in type-2 diabetics.

It was heralded as the first in a new class of medications called SGLT2 inhibitors that eliminate excess glucose by sending it through the kidneys and out the urine instead of allowing the glucose back into the bloodstream.

In June 2016, the FDA added warnings regarding Invokana’s link to kidney failure.

The revised warnings on the drug labels include information about acute kidney injury and recommendations to minimize the risk.

The FDA advises patients to seek medical attention immediately if they experience signs of Invokana-linked acute kidney injury such as decreased urine output or swelling in the legs or feet.

However, even with these symptoms present, the FDA does not advise patients to stop taking their medication without first speaking to their doctor.

An abrupt stop of Invokana can result in uncontrolled blood sugar levels that can cause even more damage.

From March 2013 to October 2015, the FDA received 101 reports of acute kidney injury, some resulting in severe kidney damage with patients needing hospitalization and dialysis.

These particular cases were confirmed because they were reported through the FDA Adverse Event Reporting System. The FDA states there are most likely additional cases that were not reported.

What Did Johnson & Johnson Know?

Johnson & Johnson is accused of knowing of the risks of severe kidney damage but keeping that information from doctors and consumers.

In fact, plaintiffs say Johnson & Johnson failed to warn physicians of the increased risks of permanent physical injuries such as diabetic ketoacidosis, stroke, heart attack and severe kidney damage.

The company is accused of failing to properly test Invokana before it was released on the market and of failing to thoroughly analyze the data resulting from the pre-marketing tests of the drug.

The lawsuit alleges that Invokana is not safe, and that it causes numerous serious side effects and permanent injuries.

The Invokana Kidney Damage Lawsuit is Case No. 3:2016-cv-05645, in the U.S. District Court for the District of New Jersey.