A Louisiana man says better warnings from Janssen Pharmaceuticals could have helped him avoid Invokana diabetic ketoacidosis injury.

Plaintiff Niles M. says he suffered an episode of ketoacidosis after taking Invokana. He claims that episode was caused by the Invokana he took, and he says he could have avoided that complication had the manufacturers of Invokana issued better product information and warnings.

Niles says he started taking Invokana in September 2014. Just a couple months later, he says he was diagnosed with diabetic ketoacidosis.

Niles names as defendants Janssen Pharmaceuticals, its parent company Johnson & Johnson, and several other companies all of whom are involved in the development, manufacture or sale of Invokana. Had these companies published better warnings about Invokana diabetic ketoacidosis injury, he says, he never would have taken Invokana.

Invokana is also known by its generic name canagliflozin. It was approved by the FDA in March 2013 as a way to help persons with type-2 diabetes keep their blood sugar levels under control.

Invokana is the first of a new class of diabetes medications to earn FDA approval. This class, known as SGLT2 inhibitors, work by getting the kidneys to excrete excess blood sugar instead of letting it be reabsorbed into the blood.

FDA Cites Reports of Invokana Diabetic Ketoacidosis Injury

Ketoacidosis is a condition in which the blood’s acidity is raised by an elevated level of ketones, acidic compounds that build up as a result of fat metabolism. Maintaining blood acidity at the right level is crucial for health. Too much acidity is a medical emergency that threatens the patient with coma or death.

Diabetic ketoacidosis is a familiar condition for many diabetic patients. However, it’s typically associated more with type-1 diabetes than with type-2. Since Invokana is approved only to treat type-2 diabetes, Invokana diabetic ketoacidosis injury is different from the ketoacidosis usually seen in diabetes patients.

The FDA addressed this issue in a May 2015 warning. The agency advised patients and doctors that it had received several reports of Invokana diabetic ketoacidosis injury in patients who had taken Invokana or other SGLT2 inhibitors.

The agency followed up in December 2015 by ordering a label change for Invokana to reflect these reports of ketoacidosis. Niles says that before that label change, Invokana’s label failed to warn about the risk of ketoacidosis

Besides ketoacidosis, other significant complications have also been reported in conjunction with Invokana treatment. Regulators in the U.S and Canada have issued warnings about links between Invokana and conditions like premature bone loss, bone fractures, and acute kidney injury.

Niles accuses Janssen Pharmaceuticals and the other defendants of over-promoting Invokana. He says the companies continued to promote Invokana as being safe and effective at the same time they knew about the risks of ketoacidosis and other complications.

He also says the defendants “have aggressively marketed and continue to aggressively market Invokana to doctors and directly to patients for off-label purposes, including, but not limited to weight loss, reduced blood pressure, kidney benefits, cardiovascular benefits, and for use in type 1 diabetics.”

Niles’s Invokana Diabetic Ketoacidosis Injury Lawsuit is Case No. 2:17-cv-01210, in the U.S. District Court for the Eastern District of Louisiana.