FDA Warns of Genital Infection Risk With Class of Diabetes Drugs

The FDA is warning that a rare genital infection may be linked to a class of diabetes medications.

From March 2013 to May 2018, the agency said it received word of 12 cases of Fournier’s gangrene – a potentially life-threatening bacterial infection of tissue under the skin around the genitals – in people taking an SGLT2 (sodium-glucose cotransporter-2) inhibitor. One of the patients died and others required “multiple disfiguring surgeries” or experienced complications. The bacteria usually enters the body through a cut in the skin.

Common SGLT2 inhibitors are Farxiga (dapagliflozin), Invokana (canagliflozin), Jardiance (empagliflozin) and Steglatro (ertugliflozin).

The FDA pointed out that Fournier’s gangrene is extremely rare, occurring in 1.6 out of 100,000 males in the US annually. The agency said of the 12 cases it is aware of, 7 were in men and 5 were in women.

As a result of the reports, the FDA is requiring that a warning about the risk of Fournier’s gangrene be added to the prescribing information for all SGLT2 inhibitors.


Jonathan Block

Jonathan Block

Jonathan Block is an associate editor at BioCentury, which provides news and information about the biotechnology and pharmaceutical industries. Prior to joining BioCentury in 2019, Jonathan worked for MedShadow as content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.


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