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Side effects of the diabetes drug Farxiga allegedly caused an Ohio man to suffer permanent and disfiguring injuries, after he contracted a rare flesh-eating infection that attacks the groin area known as Fournier’s gangrene.
In a complaint (PDF) filed in Delaware Superior Court on August 26, Robert Jones indicates AstraZeneca failed to warn doctors and users of Farxiga about the groin infection risk.
Jones was prescribed Farxiga for the treatment of type 2 diabetes in August 2016, stating that he continued to use the medication until October 2018. However, in July 2018, he was hospitalized due to complaints of fever, scrotal pain and swelling, and erythema, resulting in a Fournier’s gangrene diagnosis, which is also known as necrotizing fasciitis of the groin.
According to the lawsuit, Jones had to undergo numerous surgeries and procedures due to the Farxiga groin infection, including excisional debridement of the groin and scrotum, wound VAC, wound exploration and wound closure procedures, which caused him to be hospitalized for at least 23 days.
“Plaintiff’s injuries were 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 warnings, and willful misrepresentations concerning the nature and safety of Farxiga,” the lawsuit states. “This conduct and the product defects complained of brought about and/or were substantial factors in bringing about and exacerbating Plaintiff’s injuries.”
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 Jones 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.