A Texas man who suffered diabetic ketoacidosis claims Invokana is unreasonably dangerous after the medicine caused the condition and other ill effects.

Robert G. started to take Invokana in early December 2014 to control his blood sugar. He suffered diabetic ketoacidosis in mid-January 2015.

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

Invokana was 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.

The FDA ordered all manufacturers of SGLT2 inhibitors to include warning labels about the risk of ketoacidosis in December 2015.

In June 2016, the FDA strengthened warnings for Invokana linked to kidney failure. The revised warnings in the drug labels include information about acute kidney injury and recommendations to minimize the risk.

Johnson & Johnson allegedly knew of the risks of kidney failure and ketoacidosis, but concealed these risks from doctors and the public.

From March 2013 to October 2015, the FDA received 101 cases of acute kidney injury, some needing hospitalization and dialysis.

These 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 Is Ketoacidosis?

Ketoacidosis means the body has produced an abnormally high level of blood acids, which can lead to brain swelling and kidney failure.

When the body’s cells don’t receive the glucose they need for energy, the body begins to burn fat for energy, a process that produces ketones. These ketones break down the fat to turn it into energy. When the ketones build up in the blood, the resulting ketoacidosis can make a person extremely ill.

Dry mouth or excessive thirst, frequent urination and high blood sugar are early symptoms of ketoacidosis.

Constant fatigue, dry or flushed skin, abdominal pain, vomiting, difficulty breathing and a fruity breath odor are signs of advanced ketoacidosis.

The FDA received 20 cases of diabetic ketoacidosis in patients being treated with SGLT2 inhibitors from March 2013 to June 6, 2014.

It is a type of acidosis that develops when insulin levels are too low or during prolonged fasting. Invokana is unreasonably dangerous because it encourages this type of rare, but serious, acidosis.

Money Hides That Invokana Is Unreasonably Dangerous

According to a public interest website, ProPublica, Johnson & Johnson spent more than $7 million on doctor speaking fees and related support for the drug’s marketing efforts from August to December 2013.

Of that money, $4 million was spent on speaking fees, $2 million for doctors’ food and drinks and $900,000 for what was termed “consulting fees.”

Johnson & Johnson spent an additional $16 million on ads placed in medical journals to lull the medical community into not seeing Invokana is unreasonably dangerous.

Invokana lawsuits are continuing to grow and show many similarites in the onset of symptoms and resulting diagnoses of kidney failure and/or ketoacidosis, and with them all alleging that Invokana is unreasonably dangerous.

The Invokana Lawsuit is Case No. 3:16-cv-08739, in the U.S. District Court for the District of New Jersey, Trenton Division.