Fournier’s Gangrene Lawsuit Filed Over Farxiga Infection Risk

According to a recently filed product liability lawsuit, a Georgia man suffered a life-threatening, flesh-eating infection on his groin, known as Fournier’s gangrene, which he alleges was caused by side effects of the diabetes drug Farxiga.

The complaint (PDF) was filed late last month by Jon Paul Morgan and his wife, Ashley, in Delaware state court, indicating that side effects of Farxiga caused a Fournier’s gangrene infection, which resulted in hospitalization in an intensive care unit (ICU), several surgical procedures and left him with permanent and debilitating injuries.

Morgan’s lawsuit names AstraZeneca as the defendant, stating that he was prescribed Farxiga in May 2018, for the treatment of type 2 diabetes, weight loss, and to reduce his blood pressure. However, in February 2019, he was diagnosed with Fournier’s gangrene and hospitalized.

After two unsuccessful incision and drainage attempts, Morgan was placed in the ICU, where he was intubated before undergoing additional surgeries and incisions to remove the infection, which was diagnosed as necrotizing fasciitis of the perineum and genital region.

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

In August 2018, the FDA warned that Farxiga and other SGLT-2 inhibitors were linked to 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.

“Prior to the FDA’s August 29, 2018 safety announcement, Farxiga’s labeling failed to warn prescribing physicians and patients of the serious risk of necrotizing fasciitis of the genital/perianal/gluteal regions or Fournier’s gangrene,” Morgan’s lawsuit states. “The current labeling does not warn that a patient might lose part of his or her genitals. Thus, Defendants continue to fail to ensure that full and correct labeling and warnings were and/or are used in materials provided to prescribing physicians.”

An analysis of 12 Fournier’s gangrene cases led to the FDA’s safety alert in 2018, after which the agency required new label warnings be added to all drugs belonging to the class, including Invokana, Invokamet, Invokamet XR, Farxiga, Xigduo XR, Qtern, Jardiance, Glyxambi, Synjardy, Synjardy XR, Steglatro, Segluromet and Steglujan. Steglatro was the only drug not linked to a case of flesh-eating genital infection, but the agency is requiring it to carry a label warning anyway.

The agency indicated the infections developed within several months of beginning treatment with one of the drugs and all 12 patients underwent hospitalization and surgery. According to the FDA’s findings, at least one patient died, while others suffered multiple disfiguring surgeries and other complications.

Other Side Effects of Farxiga and Similar Drugs

The flesh-eating genital infection warning was just one of several adverse health risk added to Farxiga and similar drugs since they were first introduced on the market. The previous warnings included kidney failure, diabetic ketoacidosis and amputations (specifically for Invokana). The drugs did not carry warnings for any of those risks when they were first approved by the FDA.

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 Farxiga 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 allege 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.