(CBS) The U.S. Food and Drug Administration is issuing a warning
about a certain class of type 2 diabetes medicine following
reports of serious genital infections and one death.
The bacterial infection of the genitals and area around the
genitals is called necrotizing fasciitis 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
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.