Fournier's Gangrene

Fournier's gangrene is necrotizing fasciitis of the perineum: a fast-moving bacterial infection that kills the tissue under the skin in the genital area, the area between the genitals and anus, and nearby skin. It is a surgical emergency. Treatment requires hospitalization, strong intravenous antibiotics, and often repeated surgeries to remove dead tissue, sometimes followed by reconstruction. The CDC notes that for necrotizing fasciitis in general, even with treatment, up to 1 in 5 people have died from the infection.

Risk factors include diabetes, obesity, a weakened immune system, alcohol misuse, and recent surgery or injury in the area. Early symptoms can include pain, tenderness, redness, or swelling in the genital area along with fever or feeling unwell, and pain that seems far worse than the visible skin changes.

The term is well known in litigation because of diabetes drugs. In August 2018, the FDA warned that cases of Fournier's gangrene had been reported in patients taking SGLT2 inhibitors and required a warning on the labels of all drugs in the class, which includes Invokana, Farxiga, Jardiance, and Steglatro. Current labels tell doctors to evaluate patients with pain, tenderness, redness, or swelling in the genital area promptly.

Lawsuits have claimed the drug makers should have warned sooner. A claim would typically require proof of SGLT2 inhibitor use and hospital records confirming the diagnosis. Anyone taking these drugs with those symptoms should seek emergency care. See what is MDL for how drug cases are organized and class action vs. mass tort. This page is general information, not medical advice.