A Texas man indicates the side effects the diabetes drug Farxiga led to an infection that devoured critical tissue in his genital area, resulting in painful and permanent injuries.
Kevin D. Suber and his wife, Sherie, filed the complaint (PDF) on November 12 in Delaware Superior Court, indicating AstraZeneca failed to adequately warn consumers and the medical community about the risks associated with the medication.
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 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. However, Suber indicates the makers of Farxiga failed to disclose information about these problems, which AstraZeneca knew or should have known years earlier.
Suber indicates he was prescribed Farxiga by his treating physician in February 2015, for the treatment of type 2 diabetes. However, in August 2016 he was diagnosed with necrotizing fasciitis after he was admitted to an emergency room with the flesh-eating infection, which extended from his scrotum to his perineum. He suffered from dizziness, blurry vision, headache and abdominal pain, and he was hospitalized for at least 10 days due to the condition,which destroyed “critical tissue” in his genital area.
Even now, despite updated label warnings required by the FDA only a few years after Suber’s injury, the complaint indicates information provided by the manufacturer of Farxiga is still inadequate.
“The label does not warn of the severity, frequency or duration of injuries associated with necrotizing fasciitis of the genital/perianal/gluteal regions (including Fournier’s gangrene),” the 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.”
Suber’s 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.