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According to allegations raised in a recently filed product liability lawsuit, AstraZeneca knew about the risk that side effects of Farxiga may cause users of the diabetes drug to experience disfiguring and potentially fatal flesh-eating groin infections, yet withheld warnings from consumers and the medical community until August 2018.
The complaint (PDF) was filed by James Kennon in Delaware Superior Court on August 4, indicating that Farxiga poses an unreasonable risk that users will experience necrotizing fasciitis of the genital region, also known as Fournier’s gangrene.
Kennon, of California, indicates he was prescribed Farxiga for treatment of type 2 diabetes in July 2014, and continued to use the medication until January 2017. During that time, the drug warning label did not warn about the risk of flesh-eating infections linked to Farxiga and other similar diabetes drugs from the same class.
In April 2018, Kennon indicates that he was initially diagnosed with perirectal abscess and sepsis. However, following an irrigation and debridement procedure, it was discovered he was suffering from Fournier’s gangrene, severe septic shock, pancreatitis and acute respiratory failure.
As a result of the Farxiga infection, Kennon had to have his testes removed and was hospitalized for at least 20 days, all of which the lawsuit blames on side effects of the medication.
“Defendants knew or should have known of the risks of necrotizing fasciitis of the genital/perianal/gluteal regions (including Fournier’s gangrene) based on basic principles of infectious disease science and data available to it or that could have been generated by it,” Kennon’s lawsuit states. “Defendants also knew or should have known that the mechanism of action for Farxiga causes an extraordinary risk of necrotizing fasciitis of the genital/perianal/gluteal regions (including Fournier’s gangrene) among Farxiga users.”
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 required drug makers to add new warnings indicating Farxiga and other SGLT-2 inhibitors were linked to an increased risk of flesh-eating groin infections, which attacks the genitals and the surrounding area.
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.
The case brought by Kennon joins a growing number of 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.