The U.S. Food and Drug Administration is issuing a warning about a certain class of

following reports of serious genital infections and one death.

The bacterial infection of the genitals and area around the genitals is called

of the perineum, also called Fournier's gangrene. The bacteria typically enter the body through a cut or break in the skin.

In a news release, the FDA says between March 2013 and May 2018, 12 cases of Fournier's gangrene were identified in patients taking an SGLT2 inhibitor.

Fournier's gangrene developed within several months after the 12 patients starting taking an SGLT2 inhibitor, and use of the drug was stopped in most cases. All 12 patients were hospitalized and required surgery. Some patients required multiple disfiguring surgeries, some developed complications, and one patient died.

According to the FDA, 1.7 million patients in the U.S. filled prescriptions for an SGLT2 inhibitor at outpatient retail pharmacies.

The FDA warns that patients should seek medical attention immediately if they experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell.