A Kentucky woman’s Invokana problems have led her to bring products liability claims against the drug’s manufacturers.

Plaintiff Janet D. says she was prescribed Invokana sometime around November 2014 as a treatment for her type-2 diabetes.

While using Invokana, she says she suffered a life-threatening episode of ketoacidosis in December 2015.

Complications of her ketoacidosis landed her in the hospital for several days, she claims. Even now, she expects she will continue to need treatment for her Invokana problems into the future.

Janet now claims she could have avoided these alleged Invokana problems had the drug’s manufacturers issued a proper warning about the drug’s side effects.

Had she and her physicians known about the real risks of Invokana problems, she claims, she would not have taken Invokana and would have avoided developing ketoacidosis.

Janet’s Invokana lawsuit names as defendants Janssen Pharmaceuticals, its parent company Johnson & Johnson, Mitsubishi Tanabe, and their associated business entities.

She alleges all these companies have been involved in the development, manufacture, marketing or sale of Invokana.

Invokana Problems Can Include Ketoacidosis

Ketoacidosis is an emergent medical condition that results from a heightened level of acidity in the blood. It can start when the body cannot get all the glucose required to meet its energy needs. Cells may then begin to metabolize fat instead of glucose.

Using fat for energy produces by-products known as ketones. These acidic structures get deposited into the bloodstream. If too many ketones are produced too fast, the result can be ketoacidosis.

Ketoacidosis is considered a serious medical emergency. Patients with this condition are at risk for coma and possibly death.

Ketoacidosis is known to occur sometimes in patients with type-1 diabetes, which prevents the body from getting the glucose it needs and may force it to metabolize fat instead.

However, some episodes of ketoacidosis have also been reported in conjunction with use of Invokana, which is a treatment for type-2 diabetes.

The risk of ketoacidosis puts patients like Janet at risk for dangerous Invokana problems. Janet argues that Janssen Pharmaceuticals and the other defendants knew about this risk but failed to properly warn patients about it.

In May 2015, the FDA announced that Invokana and other drugs in the class known as SGLT2 inhibitors could expose patients to a heightened risk of ketoacidosis.

The agency followed up in December 2015 by requiring drug manufacturers to add a warning to the labels of these drugs that would alert patients and physicians to that specific risk.

Janet says that these FDA actions should have put Janssen and the other defendants on notice that patients were experiencing life-threatening side effects.

Yet Janssen still continued to advertise Invokana as a safe and effective treatment for type-2 diabetes, she claims. Janet says she and her physicians relied on these claims when she decided to start taking Invokana.

Prior to the FDA’s label change, the label for Invokana did not contain an adequate warning about the risk of ketoacidosis, Janet says.

The Invokana Lawsuit is Case No. 2:16-cv-00227 in the U.S. District Court for the Eastern District of Kentucky.