A Utah woman is suing Janssen Pharmaceuticals over Invokana adverse side effects she says she could have avoided given a proper warning.

Plaintiff Patricia M. says she developed diabetic ketoacidosis after taking diabetes drugs including Invokana, made by defendant Janssen Pharmaceuticals Inc.

She says she started taking Invokana sometime in early 2015 and another similar diabetes drug in March 2015.

Then on March 21 of that year, Patricia says she suffered an attack of ketoacidosis. She says she had to be hospitalized for seven days, spending some of that time in an intensive care unit.

Patricia believes her ketoacidosis was a direct result of the diabetes drugs she took, including Invokana.

She now accuses Janssen of purposely withholding important safety information about Invokana adverse side effects – information that could have helped her avoid suffering from ketoacidosis.

Ketoacidosis is a dangerous condition in which the blood becomes too acidic due to the presence of acidic compounds called ketones. Ketones are a by-product produced when the body metabolizes fat for energy instead of glucose.

Patients with diabetes can be at risk for ketoacidosis if the cells in their body can’t get the glucose they need and start metabolizing fat instead. It’s considered a medical emergency, and patients who suffer from ketoacidosis are at risk for coma or death.

Invokana, also known by its generic name canagliflozin, was first approved by the FDA in 2013 as a treatment for the high blood sugar levels associated with type-2 diabetes.

It’s one of a relatively new class of diabetes drugs known as the gliflozin class, also referred to as SGLT-2 inhibitors. These drugs work by stimulating the kidneys to expel excess glucose through the urine, rather than allowing it to be reabsorbed into the blood.

Patricia says that since Invokana was put on the market, the FDA has received a large number of reports of Invokana adverse side effects, particularly regarding episodes of diabetic ketoacidosis.

FDA Warns About Invokana Adverse Side Effects

The FDA issued a communication in December 2015, announcing that it had found 73 reports of patients being hospitalized for ketoacidosis related to SGLT-2 inhibitors.

With that communication, the FDA also added a warning about ketoacidosis to the label for Invokana, urging patients to seek immediate medical attention if they experienced any symptoms of ketoacidosis.

The FDA also required Janssen and other manufacturers of SGLT-2 inhibitors to undergo a five-year study of postmarket reports of ketoacidosis.

Judging by the number of reports filed with the FDA, Patricia alleges patients who take SGLT-2 inhibitors like Invokana are “several times more likely” to report ketoacidosis than patients who take other types of diabetes drugs.

But despite Janssen’s awareness of these Invokana adverse side effects, Patricia says the company continued to claim that Invokana is safe and effective.

She claims her ketoacidosis was an avoidable result of Janssen’s failure to provide proper warnings and instructions to Invokana patients.

Had she been given better warnings, she says, she would not have used Invokana and would therefore have avoided the risk of developing ketoacidois.

The Invokana Lawsuit is Case No. 1:16-cv-2718, in the U.S. District Court for the Southern District of Indiana.