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According to allegations raised in a product liability lawsuit filed against the makers of Farxiga, side effects of the diabetes drug caused a Utah man to suffer the painful and debilitating flesh-eating infection, necrotic fasciitis of the groin, which required hospitalization and left him with permanent injuries.
The complaint (PDF) was filed late last month by Sean Levi in Delaware state court, pursuing damages against AstraZeneca for failing to warn users about the risk that users may experiencing the life-threatening complication that attacks the genitals, which is also known as Fournier’s gangrene.
Levi was prescribed Farxiga for the treatment of type 2 diabetes in June 2017. However, in December 2018, he was hospitalized after visiting the emergency room after experiencing left groin pain and drainage.
According to the lawsuit, he required extensive hospitalization, including intensive care treatment in an ICU, with ventilator support. Levi had to undergo multiple and extensive surgeries, including debridement and wound cleaning to halt the effects of the flesh-eating infection.
Farxiga 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.
“Plaintiff’s injuries were preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly test Farxiga, and failure to properly assess and publicize alarming safety signals,” Levi’s lawsuit states. “Defendants actively suppressed information revealing serious and life-threatening risks with Farxiga, promoted Farxiga for weight loss, and willfully and wantonly failed to provide adequate instructions and warnings and made misrepresentations concerning the nature and safety of Farxiga. This conduct and the product defects complained of brought about and/or were substantial factors in bringing about and exacerbating Plaintiff’s injuries.”
Levi’s claim joins a growing number of similar Farxiga necrotizing fasciitis 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.