A Kentucky man is challenging Janssen Pharmaceuticals and its related companies with a new Invokana side effects lawsuit.

Plaintiff Gabriel A. says he started taking Invokana in October 2015.

Only a few weeks later, he says he was diagnosed with diabetic ketoacidosis and serious kidney injury, requiring him to undergo several days of hospitalization.

Gabriel now accuses the manufacturers of Invokana of failing to adequately warn about the possibility that their drug can lead to ketoacidosis and kidney injury, or possibly kidney failure.

Had he or his treating physicians been properly apprised of the risks associated with Invokana, he says, he never would have taken it.

Gabriel’s Invokana side effects lawsuit names as defendants Janssen Pharmaceuticals, its parent company Johnson & Johnson, Tanabe Research Laboratories, and other related companies, all of which were involved in the development, manufacture and marketing of Invokana.

Invokana, also known by the generic name canagliflozin, was approved by the FDA in March 2013 as a treatment for type-2 diabetes.

It’s one of a newer group of diabetes drugs known as sodium-glucose co-transporter 2 inhibitors, or SGLT2 inhibitors. These drugs help lower the high blood sugar levels associated with type-2 diabetes.

SGLT2 inhibitors work by blocking reabsorption of glucose into the blood in the kidneys. The excess glucose is then expelled through the urine.

According to an FDA warning issued in May 2015, SGLT2 inhibitors like Invokana may lead to diabetic ketoacidosis.

Ketoacidosis is a potentially life-threatening increase in the blood’s acidity caused by an excess of compounds called ketones.

Ketones are a by-product produced when the body can’t get enough glucose to meet its energy needs and starts metabolizing fat instead. When too many ketones build up in the blood, ketoacidosis can result.

Diabetic ketoacidosis is more frequently associated with type-1 diabetes, not type-2. According to Gabriel, this condition can lead to complications like cerebrovascular accident, myocardial infarction, or coma.

Raising the stakes for Invokana-related ketoacidosis is the fact that it does not occur in conjunction with the elevated blood sugar levels that are normally found in cases of diabetic ketoacidosis. This discrepancy can sometimes lead to an early misdiagnosis and delay of proper treatment.

In December 2015, the FDA mandated a label change for Invokana and other SGLT2 inhibitors that would add a warning about reports of ketoacidosis that occurred in patients taking these drugs.

Invokana Side Effects Lawsuit Says Companies Withheld Safety Information

Gabriel alleges the defendants improperly represented Invokana as safer than it actually is. He believes these companies over-promoted the drug while simultaneously keeping information about Invokana side effects to themselves.

These companies purposely sat on information about diabetic ketoacidosis and kidney complications that occurred in conjunction with Invokana treatment, Gabriel claims.

The “Defendants’ marketing campaign willfully and intentionally misrepresented the risks of Invokana and failed to warn about the risks of diabetic ketoacidosis, kidney failure, and cardiovascular injury,” according to this Invokana side effects lawsuit.

Gabriel’s Invokana Side Effects Lawsuit is Case No. 3:16-cv-680-JHM in the U.S. District Court for the Western District of Kentucky.