The condition, called Fournier's gangrene, has been reported in connection with sodium-glucose cotransporter-2 inhibitors, the FDA said.
According to the FDA, the drugs help the body lower blood-sugar levels through the kidneys. Excess sugar is excreted in a patient's urine, and urinary tract infections are a known side effect, the FDA said.
SGLT2 inhibitors approved by the FDA include Johnson & Johnson's Invokana, Eli Lilly & Co's Jardiance, as well those from Bristol-Myers Squibb, AstraZeneca Plc, Merck & Co and Pfizer Inc.
Fournier's gangrene is rare but can be a life-threatening bacterial infection, the FDA said. The bacteria usually enters the body through a cut or break in the skin, and then spreads and destroys the flesh it infects.
The FDA said from March 2013 to May 2018, 12 cases of Fournier's gangrene in patients taking one of the inhibitors were identified. The cases included seven men and five women, who all were hospitalized and required surgery.