A woman who suffered diabetic ketoacidosis complications has filed a lawsuit over Invokana adverse effects.

Plaintiff Pam S. says she took Invokana (canagliflozin) from mid-January 2014 through mid-December 2014. She was in the hospital from Dec. 16, 2014 through Dec. 24, 2014 where she was diagnosed with diabetic ketoacidosis. She was also suffering from acute kidney injury and other diabetic ketoacidosis complications.

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, makes Invokana.

Diabetic Ketoacidosis Complications Among Invokana Adverse Effects

Invokana entered the U.S. market in March 2013 and is in a new class of medications known as sodium glucose cotransporter-2 (SGLT-2) inhibitors.

Invokana works by redirecting excess sugar away from the bloodstream and directing it out of the body through urine. Unfortunately, diabetics already are at a higher risk of kidney ailments than the general population, and the way Invokana works puts more stress on the kidneys.

Reported Invokana adverse effects include kidney failure, heart attacks, acute kidney injury, and diabetic ketoacidosis.

Ketoacidosis is a condition caused by an abnormally high level of blood acids. It occurs when the body’s cells don’t receive enough glucose for energy. As a result, the body starts burning fat for energy, which produces ketones. When ketones build up in the bloodstream, ketoacidosis occurs.

Patients experiencing dry mouth, excessive thirst, frequent urination and high blood sugar could be experiencing early stages of ketoacidosis.

Advanced stage ketoacidosis is marked by constant fatigue, dry or flushed skin, abdominal pain, vomiting, a fruity breath odor and difficulty breathing. Brain swelling and kidney failure can be diabetic ketoacidosis complications.

In December 2015, the FDA required all SGLT2 inhibitors to include updated labels to warn of the risk of ketoacidosis.

In June 2016, the FDA added warnings for Invokana and its link to kidney failure. The revised warnings include information about acute kidney injury.

According to the diabetic ketoacidosis complications complaint, Janssen should have known the risks of diabetic acidosis and kidney failure based on data available to them, including, but not limited to:

• Animal studies pointed to increased ketones with ingestion of Invokana;
• Studies showed Invokana could not only inhibit SGLT2, but also SGLT1, which produced a propensity to cause ketoacidosis;
• Clinical studies that indicated people taking Invokana developed increased ketones and vomiting.

Plaintiffs claim Janssen allegedly withheld information regarding Invokana adverse effects and the serious diabetic ketoacidosis complications that could develop. The company allegedly “had sole access to material facts concerning, and unique and special expertise regarding, the dangers and unreasonable risks of Invokana.”

The diabetic ketoacidosis complications lawsuit alleges “[c]onsumers of Invokana and their physicians relied on the defendants’ false representations and were misled as to the drug’s safety, and as a result have suffered injuries including diabetic ketoacidosis, acute kidney injury, cardiovascular problems, amputations, and the life-threatening complications thereof.”

The Diabetic Ketoacidosis Complications Lawsuit is Case No. 3:17-cv-12205 and is part of the Invokana MDL, In re: Invokana (canagliflozin) Products Liability Litigation, MDL No. 2750, in the U.S. District Court for the District of New Jersey.