Invokana Side Effects Caused Stroke and Wrongful Death, Lawsuit Alleges

A wrongful death lawsuit filed by the family of a Florida woman indicates that the side effects of Invokana caused a fatal stroke, less than a year after she began using the new-generation diabetes drug. 

The complaint (PDF) was filed last month in the U.S. District Court for the District of New Jersey by Frederick Robinson, who indicates that Invokana caused the death of his wife, Cheryl, on December 4, 2015.

Cheryl Robinson’s death was caused by a stroke while taking Invokana to control her type 2 diabetes. She was prescribed the medication in July 2014, and suffered the stroke in April 2015, which eventually led to her death several months later.

Invokana (canagliflozin) was just introduced about a year before Robinson’s wife was prescribed the drug, which was the first member of new class of diabetes treatments, known as sodium glucose cotransporter 2 (SGLT-2) inhibitors. These drugs work in a unique way, by altering some normal kidney functions to increase the amount of sugar excreted in the urine. However, since Invokana has hit the market, a growing number of serious health risks have been reported, leading to concerns over the lack of research before introducing the drug and decisions by the drug maker to withhold certain warnings from the initial label.

“Since Invokana’s release, the FDA has received a significant number of reports of severe kidney damage and strokes among users of Invokana,” the lawsuit states. “An analysis of the FDA adverse event database shows that patients taking Invokana are several times more likely to report severe kidney damage and strokes than those taking non-SGLT2 diabetes drugs to treat diabetes.”

The case is one of the latest in a growing number of Invokana lawsuits filed in recent months, each raising similar allegations that the drug makers failed to adequately research the medication before marketing it as a new form of diabetes treatment, and withheld important safety warnings from consumers and the medical community.

As more users have been switched to Invokana, a series of warning updates have been required by federal regulators, and the public continues to learn about potential risks through adverse event reports submitted on behalf of users throughout the U.S.

In December 2015, the FDA required Johnson & Johnson and the makers of other SGLT2 inhibitors to add new diabetic ketoacidosis warnings to their medications, 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.

Less than a year later, in June 2016, the FDA required another warning label update to add information about the link between Invokana and kidney risks, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.

“[Invokana] is not safe, has numerous and serious side effects and causes severe and permanent injuries including, but not limited to, developing a stroke and other serious injuries and side effects,” according to allegations raised in the complaint filed by Cheryl Robinson’s husband. “As a result, Invokana is unfit and inherently dangerous for ordinary use.”

Given similar questions of fact and law raised in lawsuits filed throughout the federal court system, Robinson’s case will be consolidated as part of an Invokana MDL (multidistrict litigation), which is centralized before U.S. District Judge Brian Martinotti in the District of New Jersey for coordinated discovery and pretrial proceedings. However, if Invokana settlements or another resolution for the cases is not reached during the MDL process, Robinson’s case and others involved in the litigation may later be remanded to U.S. District Courts nationwide for a separate trial dates.