Side Effects of Xigduo Caused Fournier’s Gangrene Infection, Lawsuit Alleges

A product liability lawsuit has been filed by a Florida man who developed a rare and debilitating flesh-eating infection on his groin, known as Fournier’s gangrene, which was allegedly caused by side effects of the diabetes drug Xigduo.

The complaint (PDF) was filed by Roderic Johnson in Delaware Superior Court on April 12, naming AstraZeneca Pharmaceuticals as the defendant.

Xigduo includes the active ingredient from the new-generation drug Farxiga (dapagliflozin), as well as the older diabetes treatment metformin. It was approved by the FDA in October 2014, as part of a new generation of treatments known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, which also includes Invokana, Januvia and others drugs introduced for diabetes in recent years.

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, involving infections that attack the genitals and the surrounding area, which can be life threatening.

According to the lawsuit, Johnson began treatment with Xigduo in January 2016. A month later, in February 2016, he was admitted to the hospital and had to undergo surgery due to an abscess which had appeared in his left groin.

Johnson returned to the hospital in October 2016, due to a complicated abscess to the perineum, the lawsuit states. It was then he was diagnosed with Fournier’s gangrene, also known as necrotizing fasciitis, requiring extensive post-operative wound care and rehabilitation therapy.

The lawsuit alleges AstraZeneca failed to adequately warn the medical community and patients about the risks of Xigduo infections.

“Had Plaintiff and Plaintiff’s physician(s) known the true risks associated with the use of SGLT2 inhibitors, including Xigduo, Plaintiff would not have been prescribed Xigduo; and Plaintiff would have refused to take Xigduo,” the lawsuit states. “Additionally, and alternatively, at a minimum, Plaintiff would have been adequately monitored for side effects from Xigduo, and as a result, would not have suffered injuries and damages from using 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.

Johnson’s complaint joins a growing number of similar Xigduo and Farxiga lawsuits over Fournier’s gangrene infections filed in recent months by former users of the diabetes drug, each raising similar allegations that users would have avoided the diabetes drug if earlier warnings and information had been provided about the potential risks.