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AstraZeneca faces a growing number of product liability lawsuits over the side effects of Farxiga, indicating that the diabetes drug caused plaintiffs to suffer a serious and potentially life-threatening, flesh-eating infection that attacks the groin and genitals.
In a complaint (PDF) filed late last week in the U.S. District Court for the Southern District of Texas, Michael Bustamante indicates the drug maker knew about the association between Farxiga and the rare form of necrotizing fasciitis of the genitals, known as Fournier’s gangrene, yet withheld information from users and the medical community.
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.
Bustamante indicates he began taking Farxiga in 2018 to help treat his Type 2 diabetes, and was left with permanent injuries that could have been prevented.
“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 perineum and genital region, and other injuries the full extent of which are not yet realized,” the lawsuit states. “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.”
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.
Other Side Effects of Farxiga and Similar Drugs
The flesh-eating genital infection warning was just one of several adverse health risk added to Farxiga and similar drugs since they were first introduced on the market. The previous warnings included kidney failure, diabetic ketoacidosis and amputations (specifically for Invokana). The drugs did not carry warnings for any of those risks when they were first approved by the FDA.
Invokana (canagliflozin) was the first SGLT-2 inhibitor introduced to the market, which was approved in March 2013 and quickly became a blockbuster treatment. The medication works in a unique way, impacting some normal kidney functions to help remove glucose from the body through urine.
In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana and similar drugs, indicating the medications increase the risk of this serious condition, which typically results in the need for emergency treatment to avoid life-threatening injury. Prior to the update, the warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.
In June 2016, the FDA required additional label warnings about the link between kidney risks and Farxiga and other drugs from its class, indicating the medications may increase the risk of acute kidney injury and other severe health problems.
Johnson & Johnson and Janssen faced several thousand other Invokana lawsuits, which allege users and the medical community were not provided adequate warnings at the time the drug was first introduced. The makers of other diabetes drugs from the same class, including Xigduo and Farxiga, have also faced similar lawsuits; though most have been filed against the makers of Invokana.