Xigduo Lawsuit Filed Over Fournier’s Gangrene Diagnosis

According to allegations raised in a recently filed product liability lawsuit, side effects of Xigduo caused a Mississippi man to develop a life-threatening infection that attacked his genitals after exposure to the diabetes drug.

The complaint (PDF) was filed by Tommy Jones, Jr. in Delaware Superior Court on May 19, indicating that AstraZenca failed to warn about the link between Xigduo and Fournier’s gangrene, which is a rare flesh-eating genital infection recently linked to a class of diabetes drug known as sodium-glucose cotransporter-e (SGLT-2) inhibitors.

Xigduo is a combination treatment sold by AstraZenca, which includes the the diabetes drugs Farxiga (dapagliflozin) and metformin. It was approved by the FDA in October 2014, and is part of a new generation of diabetes treatments, which also includes Invokana, Januvia and others drugs.

In August 2018, the FDA warned that Xigduo and other SGLT-2 inhibitors were linked to an increased risk of necrotizing fasciitis of the perineum, also known as Fournier’s gangrene. The infection attacks the genitals and the surrounding area and can be life threatening.

According to the lawsuit, Jones was prescribed Xigduo in August 2015, and used the drug through at least September 2018. However, in May 2018, Jones was hospitalized due to a Fournier’s gangrene infection, which turned septic.

As a result of the genital infection caused by the diabetes drug, Jones had to undergo surgery, which included incision, draining, extensive soft tissue debridement of the right groin and perineum, requiring extensive therapy and rehabilitation.

“Defendant knew or should have known of the significant risk of serious genital infections, including Fournier’s gangrene, caused by Xigduo, but did not adequately and sufficiently warn consumers (including Plaintiff) or the medical community of the severity of such risks,” the lawsuit states. “Indeed, Defendant conducted nationwide sales and marketing campaigns to promote Xigduo, and willfully deceived the general public (including Plaintiff) and the medical community (including Plaintiff’s healthcare providers) as to the safety and effectiveness of Xigduo.”

An analysis of 12 cases of Fournier’s gangrene 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 Health Concerns Linked To Xigduo and Similar Drugs

The flesh-eating genital infection warning was just one of several adverse health risk added to Xigduo 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 that 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 Xigduo 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.