Patient dies from genital infection linked to diabetes drugs, FDA warns

One patient has died and 11 others have been hospitalized with a serious genital infection linked to a certain class of diabetes drugs, the FDA said Aug. 29.

The 12 cases were reported between March 2013 and May 2018.

The FDA's warning is for a class of medicines called SGLT2 inhibitors used by adults with Type 2 diabetes to lower blood sugar.

The infection, called Fournier's gangrene, is a rare but life-threatening bacterial infection of the tissue under the skin that surrounds the genital area, the FDA said. The bacteria typically get into the body through a cut and spread rapidly, and having diabetes is a risk factor for the infection.

Healthcare professionals should assess patients for Fournier's gangrene if they present with 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, the FDA said.

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