The Food and Drug Administration (FDA) announced August 29 on their website that certain common classes of medications used for the treatment of type 2 diabetes have been linked to cases of deadly, flesh-eating genital infections. Although the cases have been rare, they have caused a dangerous bacterial infection to occur in some patients’ genital areas and around that specific area.
The diabetes-treating medications affected are “sodium-glucose cotransporter-2 (SGLT2) inhibitors,” according to the FDA. They stated that more than a dozen drugs will be required to carry the warning that these meds can cause life-threatening flesh-eating genital infections. Because of the cases, the agency is ordering the companies to add a new warning to the medication guides and prescribing information of the SGLT2 inhibitors that are affected. Brand names the FDA lists as affected include Farxiga, Invokana, and Jardiance.
The FDA first approved SGLT2 inhibitors to be used and teamed with a healthy diet and exercise in an effort to help lower blood sugar in patients that have type 2 diabetes.
According to USA Today, the warning was issued after the FDA documented 12 cases of flesh-eating genital infections occurring in patients that took SGLT2 inhibitors for five years during the period between March 2013 to May 2018. In comparison, there have only been six cases of the dangerous infection occurring in patients that took other classes of diabetes-treating medications for more than 30 years. The FDA went on to say that in the 12 cases they studied, all the patients needed to have surgery and that some of the surgeries caused disfiguring results. Per CBS News, the agency reported that one of the 12 patients died.
The infection that prompted the warning is called Fournier’s gangrene, which is a potentially deadly infection that happens when necrotizing fasciitis enters the genitals and surrounding area. Fournier’s gangrene affects areas between the anus and vulva or scrotum, otherwise known as the perineum. Necrotizing fasciitis gets its name as the flesh-eating bacteria because the infection kills tissue rapidly at the tissue site and beyond.
Between 600 and 700 cases of flesh-eating bacteria in patients are diagnosed annually in the U.S., and of those cases, about 25-30 percent of those cases result in death, especially if not treated promptly. The bacteria often enters a patient’s body through breaks or cuts in the skin.
Also, according to findings in a 2012 study by the ISRN Surgery and U.S. National Library of Medicine, Fournier’s gangrene has a 20 percent mortality rate; and that’s for a person with no associated health problems. Infectious diseases are often more frequent and serious for individuals with diabetes, and the 20 percent mortality rate of this serious and potentially deadly flesh-eating genital infection can be higher because of that reason.
The FDA issued the following warning for patients to seek medical treatment if they experience the following while taking SGLT2 inhibitors,
“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.”