An Indiana woman indicates she suffered a severe flesh-eating infection which attacked her genitals, known as necrotizing fasciitis, due to side effects of the diabetes drug Farxiga, according to a recently filed product liability lawsuit.
In a complaint (PDF) filed last week in Delaware Superior Court, Cynthia Johnson indicates she was prescribed Farxiga in February 2018 for treatment of her type 2 diabetes, and continued to use the medication for several months until December 2018, after she developed this severe and life-threatening infection.
After she was diagnosed with necrotizing fasciitis of the genitals, also known as Fournier’s gangrene and was hospitalized from November 16 to December 7, 2018. During this time, she had to undergo multiple surgical debridement procedures and indicates that she has been left with permanent and painful injuries.
“After beginning treatment with Farxiga, and as a direct and proximate result thereof, Plaintiff required extensive medical treatment and suffered debilitating injuries, including, but not limited to, destruction of critical tissue and bodily structures, necrotizing fasciitis of the genital/perianal/gluteal regions, and other injuries the full extent of which are not yet realized,” Johnson’s lawsuit states. “These debilitating injuries required invasive procedures, surgical procedures and extensive hospitalization.”
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 makers of all medications in this class to add new warnings about the risk of flesh-eating groin infections from the diabetes drugs, including Farxiga, Xigduo XR, Invokana, Invokamet, Invokamet XR, Jardiance, Glyxambi, Qtern, Synjardy, Synjardy XR, Steglatro, Segluromet and Steglujan.
The warning was issued after an analysis of 12 Fournier’s gangrene cases in 2018, which found that the infections typically began within several months after starting the treatment, and all 12 patients required hospitalization and surgical treatments. According to the FDA’s findings, at least one patient died, while others suffered multiple disfiguring surgeries and other complications.
Johnson’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.