Farxiga Wrongful Death Lawsuit Filed Over Fatal Flesh-Eating Groin Infection

AstraZeneca faces a wrongful death lawsuit over Farxiga, alleging that side effects of the diabetes drug caused a Texas woman to suffer a fatal flesh-eating infection around her groin, known as Fournier’s gangrene.

Virginia G. Kroontje filed the complaint (PDF) in the Superior Court of Delaware on December 11, on behalf of herself and the estate of her mother, Celia N. Gonzales, who died on December 19, 2018, after developing the flesh-eating groin infection from Farxiga.

Gonzales was prescribed Farxiga in September 2017, for treatment of Type 2 diabetes. The drug is part of a new generation of diabetes treatments 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 required the makers of Farxiga and other SGLT2 inhibitors to add new warnings about the risk of flesh-eating groin infections from the diabetes drugs, after an analysis identified at least 12 cases for Fournier’s gangrene among users. The infections typically began within a few months after starting the treatment, and all 12 patients required hospitalization and surgical treatment, with at least one death.

Kroontje states that if her mother or her mother’s doctor known about the risk of groin infections linked to Farxiga, she would have chosen a different medication, or at least would have monitored more closely for side effects.

“After beginning treatment with Farxiga, and as a direct and proximate result thereof, Decedent required extensive medical treatment and suffered debilitating injuries, including, but not limited to, surgical debridement of skin, subcutaneous tissue, muscle and fascia of the genitalia and perineum for necrotizing soft tissue infection,” the lawsuit states. “Decedent died in the hospital on December 19, 2018 from multiorgan system failure due to sepsis from necrotizing fasciitis of the genital/perianal/gluteal regions (Fournier’s gangrene).”

Kroontje’s wrongful death case joins a growing number of similar Farxiga lawsuits filed in recent months by former users of the diabetes drug, each raising similar allegations that the severe groin infections may have been avoided, or been less severe, if users and the medical community had been warned earlier about the potential risks.