A case of severe kidney injury has sparked an Invokana life-threatening side effects lawsuit.

Plaintiff James B. of Alabama is suing Invokana makers Janssen Pharmaceuticals, Inc., Johnson & Johnson Co. and Mitsubishi Tanabe Pharma Corp.

Designed to control blood sugar in Type 2 diabetics, Invokana has been found to sometimes cause kidney damage and ketoacidosis.

A person develops ketoacidosis when the body produces an abnormally high level of blood acids, which can lead to brain swelling and kidney failure.

James started taking Invokana to help regulate his blood sugar in October 2014.

On or about Nov. 11, 2014, James developed kidney failure or serious kidney injury that required hospitalization.

According to the complaint filed in court, complications ensued, causing him to endure pain and suffering, emotional distress, loss of enjoyment of life and economic loss.

Invokana Side Effects Can Be Serious

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

It initiated 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.

According to the According to the Invokana life-threatening side effects lawsuit, SGLT2 inhibitors are designed to target the SGLT2 receptors, but some of these medications block other sodium or glucose transporter receptors, including SGLT1.

SGLT2 and SGLT1 receptors are found throughout the human body, including the kidney, intestines and brain.

Of all the SGLT2 inhibitors currently on the market, “Invokana has the highest selectivity for the SGLT1 receptor among SGLT2 inhibitors currently marketed in the United States,” according to the Invokana life-threatening side effects lawsuit.

Since its FDA approval, Invokana’s manufacturers have been accused of withholding information from the FDA and misrepresenting material information regarding the risks and benefits of Invokana in its communication with the regulatory body.

The FDA was not informed of instances of diabetic ketoacidosis and other adverse events found in clinical trials.

Among the updates that have been ordered for Invokana’s packaging:

• In May 2015, the FDA said that Invokana can cause diabetic ketoacidosis.
• In September 2015, the FDA announced that Invokana causes premature bone loss and fractures.
• In October 2015, Health Canada, the drug regulatory authority, announced that Invokana can cause acute kidney injury.
• In December 2015, the FDA ordered that the label for SGLT2 inhibitors such as Invokana include a warning of ketoacidosis.

The FDA ordered all manufacturers of SGLT2 inhibitors to include warning labels about the risk of ketoacidosis in December 2015, just about one year after the plaintiff started his suffering of Invokana diabetic ketoacidosis side effects.

According to the Invokana life-threatening side effects lawsuit, Janssen Pharmaceuticals, Johnson & Johnson, and Mitsubishi Tanabe allegedly knew of the risks of ketoacidosis and of kidney damage, but concealed the risks from both the medical community and the public.

Invokana Life-Threatening Side Effects Lawsuit

In addition to the allegations of concealing severe side effects, the manufacturers are accused of making Invokana in an inconsistent manner.

According to the Invokana life-threatening side effects lawsuit, the manufacturers “failed to properly manufacture Invokana to ensure consistent quality with each batch that matched the (flawed) design specifications. The failure of consistent manufacture stemmed from faulty manufacturing processes, sub-par raw materials, and failure to properly clean and maintain equipment and other manufacturing facilities to ensure no cross-contamination from microbes and cleaning products.”

The Invokana Life-threatening Side Effects Lawsuit is Case No. 5:16-cv-01809-HGD, in the U.S. District Court for the Northern District of Alabama.