Invokana Stroke Lawsuit Filed Over Failure to Warn About Diabetes Drug Side Effects

The side effects of Invokana caused a woman to suffer a stroke, according to allegations raised in a recent product liability lawsuit filed against Johnson & Johnson over their new-generation diabetes drug. 

The complaint (PDF) was filed late last month in the U.S. District Court for the District of New Jersey by Yvette Humphries and her husband, Greg, naming Johnson & Johnson, its Janssen Pharmaceuticals subsidiary, and Mitsubishi Tanabe Pharma Corp. as defendants.

Humphries indicates that she was prescribed Invokana in October 2015, but stopped taking the new diabetes drug the very next month, after suffering a stroke. The lawsuit blames side effects of the medication for causing the injury, alleging that the drug makers have withheld information about the link between Invokana and strokes.

“Defendants knew of the significant risk of stroke caused by ingestion of Invokana,” the complaint states. “However, Defendants did not adequately and sufficiently warn consumers, including Plaintiff Yvette Humphries, or the medical community of the severity of such risks.”

The case joins a growing number of Invokana lawsuits filed in recent months over problems associated with the diabetes drug, which has only been on the market for three years. The complaints indicate that the drug makers placed their desire for profits before consumers safety by failing to adequately research the medication before it was introduced and aggressively marketed as a superior diabetes treatment. In addition to Invokana stroke cases, lawsuits allege the drug has caused individuals to suffer diabetic acidosis, heart attacks, kidney failure and other injuries.

Invokana Risks

Invokana (canagliflozin) was introduced in March 2013, as the first member of a new class of diabetes drugs, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Amid aggressive marketing by the drug maker following approval, the medication was quickly adopted by the medical community, but a steady stream of potential safety risks with Invokana have emerged over the past few years.

Only two years after the drug was introduced in the United States, the FDA launched an investigation into a link between Invokana and ketoacidosis in May 2015, after identifying at least 20 reports of individuals being hospitalized due to acid problems with the drug or other members of the SGLT2 inhibitor class of diabetes medications.

Following a safety review, the FDA ultimately required Johnson & Johnson to add new Invokana warnings about ketoacidosis in December 2015, urging users to stop taking the drug and seek immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.

In September 2015, the FDA required new Invokana bone fracture warnings, indicating that the drug may also lead to decreased bone density.

A detailed review of adverse event reports submitted to the FDA during the first year Invokana was on the market, which was conducted by the Institute of Safe Medication Practices (ISMP), identified a potential risk of kidney damage with Invokana and other SGLT2 inhibitors.

Invokana and other members of this new-generation diabetes treatments work in a unique way, by impacting the normal function of the kidneys. However, investigators identified reports of kidney failure and other problems that they suspected were caused by the medication.

Other members of the SGLT2 inhibitor class of diabetes drugs include Invokamet, Farxiga, Xigduo, Jardiance and Glyxambi.