Invokana Side Effects Led To Fournier’s Gangrene Diagnosis, Lawsuit Claims

Manufacturers of the diabetes drug Invokana knew or should have known that side effects may cause Fournier’s gangrene, but failed to warn users and the medical community about the risk they may develop the serious and potentially a life-threatening genital infection, according to a recently filed product liability lawsuit.

Russell Mullis filed the complaint (PDF) in the U.S. District Court for the Southern District of Georgia on June 10, indicating that he developed the flesh-eating infection due to the defective formulation of Invokana.

The lawsuit names Janssen Pharmaceuticals, Inc. and its parent company, Johnson & Johnson, as defendants, indicating that inadequate warnings were provided when the new-generation diabetes drug was introduced.

Mullis began taking Invokana in 2015 to treat his type 2 diabetes. However, he was diagnosed with Fournier’s gangrene and had to undergo surgery which included an incision, drainage, and debridement of his scrotum, and the need for a wound vac on the site of the infection.

Invokana is part of a new class of diabetes drugs, known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, which also includes Jardiance, Farxiga, Invokamet, Xigduo XR and others.

In August 2018, the FDA required manufacturers of Invokana and other SGLT-2 inhibitors to add new warnings about an increased risk of Fournier’s gangrene, which is also known as necrotizing fasciitis of the perineum. The infection attacks the genitals and the surrounding area and can be life threatening. However, Mullis indicates that the manufacturers knew or should have known about the risk earlier and added information to the drug warning label.

“The development of Plaintiff’s injuries was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana” the lawsuit states. “This conduct, as well as the product defects complained of herein, was a substantial factor in bringing about and exacerbating Plaintiff’s injuries.”

Invokana Health Concerns

The flesh-eating genital infection risk from Invokana is one of several adverse health risks linked to the diabetes drug after it was approved and widely marketed for use by type 2 diabetics. Other post-marketing warning unpdates have ben issued for kidney risks, diabetic ketoacidosis and amputations, which were not included on the drug warning label at the time it was introduced.

Invokana (canagliflozin) was the first SGLT-2 inhibitor introduced to the market, which was approved in March 2013 and quickly became a blockbuster treatment. The medication works in a unique way, impacting some normal kidney functions to help remove glucose from the body through urine.

In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana and similar drugs, indicating that the medications increase the risk of this serious condition, which typically results in the need for emergency treatment to avoid life-threatening injury. Prior to the update, the warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.

In June 2016, the FDA required additional label warnings about the link between kidney risks and Invokana and other drugs from its class, indicating the medications may increase the risk of acute kidney injury and other severe health problems.

Johnson & Johnson and Janssen faced several thousand other Invokana lawsuits, which alleged that users and the medical community were not provided adequate warnings at the time the drug was first introduced. The makers of other diabetes drugs from the same class, including Xigduo and Farxiga, have also faced similar lawsuits; though most have been filed against the makers of Invokana.