Plaintiff Teresa R. is suing the makers of diabetes drug Invokana, which she alleges caused her to suffer starvation ketosis.

Invokana is prescribed to maintain lower blood sugar levels in adults with type 2 diabetes. The drug was created and is sold by Janssen Research & Development, LLC, Janssen Pharmaceuticals, Inc., Johnson & Johnson Co., and Mitsubishi Tanabe Pharma Corp. Those companies and their subsidiaries are named defendants.

Invokana belongs to a new class of drugs called SGLT2 inhibitors, which work by making the kidneys remove sugar from the body through the urine rather than have it be reabsorbed into the blood. As a result of this action, patients can become dehydrated, which causes the kidneys to work harder.

Starvation Ketosis Caused by Invokana

When the body is seeking energy and can’t find it by synthesizing glucose, the liver makes ketones to turn fat into energy. When ketones become the body’s primary sources of energy, acids build up in the blood, and starvation ketosis occurs.

Excessive ketones cause people to exhibit sweet-smelling, fruity breath and ammonia-smelling perspiration. The body also tries to expel excess acids through urine.

According to Teresa’s complaint, “Invokana-induced diabetic ketoacidosis may lead to delayed treatment because in many cases, Invokana will keep blood sugar below 250 mg/dl, a threshold often used when diagnosing diabetic ketoacidosis. This may result in increased progression of the condition and increased injury to the patient.”

Teresa alleges the makers of Invokana knew that the drug placed tremendous strain on the kidneys and could cause starvation ketosis, diabetic ketoacidosis and kidney failure, but continued to promote Invokana as a safe and effective medication to control blood sugar.

Teresa’s doctor prescribed Invokana for her in early September 2013. According to her complaint, she developed starvation ketosis on or about March 30, 2015. More serious complications continued to develop.

The Invokana lawsuit alleges her “injuries were preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals,” and other failures.

The drug’s makers are accused of suppressing serious and life-threatening risks, failing to share adequate instructions and knowingly misrepresenting the true nature and safety profile of Invokana.

In May 2015, the FDA declared that SGLT2 inhibitors such as Invokana can lead to diabetic ketoacidosis. The FDA followed up in December 2015 with a requirement that the drugs revise their labels to include warnings of the risks of ketoacidosis.

“Despite the FDA’s announcements, Defendants continue to engage in aggressive direct-to-consumer and physician marketing and advertising campaigns for Invokana,” putting more patients at risk of starvation ketosis and kidney damage.

Had Teresa known the true risks associated with Invokana, she would have not taken the drug.

Teresa and her “prescribing and treating physicians relied on claims by Defendants that Invokana has been clinically shown to improve glycemic control and was generally safe and effective.”

The Invokana Starvation Ketosis Lawsuit is Case No. 3:17-CV-02068-BRM-LHG in the U.S. District Court for the District of New Jersey.