Alert over rare genital infection in patients on SGLT2 inhibitors
The US drug regulator has issued a warning about a serious genital infection that has occurred in patients with diabetes who are taking sodium-glucose cotransporter-2 (SGLT2) inhibitors.
A total of 12 cases of Fournier's gangrene — an extremely rare but life-threatening bacterial infection of the tissue that surrounds the genital area — were reported between March 2013 and May 2018.
Of these one patient died and 11 others were hospitalised, with some requiring multiple disfiguring surgeries and developed complications, the Food and Drug Administration (FDA) said.
The infection developed within several months of the patients starting an SGLT2 inhibitor and the drug was stopped in most cases, it said, adding that there may be additional cases it was unaware of.
The FDA called for a warning of the