Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a newer group of drugs that help manage diabetes. These drugs work by helping the kidneys remove sugar from the body through urine.
While they can be effective in lowering blood sugar levels, a recent study by the U.S. Food and Drug Administration (FDA) has revealed a concerning side effect: a rare but serious infection.
The infection, known as Fournier gangrene, affects the area around the genitals, including the perineum and the region near the anus.
Fournier gangrene is a severe condition caused by bacteria spreading rapidly in soft tissues, leading to tissue death. If untreated, it can become life-threatening.
The researchers examined medical records to assess the risk of this infection in people using SGLT2 inhibitors compared to those using other common diabetes treatments like metformin, insulin, and other newer drugs such as dulaglutide.
The study reviewed cases reported between March 1, 2013, and January 31, 2019, for patients on SGLT2 inhibitors and compared them to cases dating back to 1984 for patients using other diabetes medications.
They found 55 cases of Fournier gangrene among patients taking SGLT2 inhibitors during the six-year period. The affected individuals ranged in age from 33 to 87 years old, with 39 of them being men and 16 women.
The time it took for the infection to appear after starting the medication varied widely, from as early as five days to as long as 49 months.
In addition to Fournier gangrene, these patients often suffered from other diabetes-related health problems, including diabetic ketoacidosis (a dangerous buildup of acid in the blood), severe infections like sepsis, and kidney damage.
These complications likely made their overall condition worse and highlighted the seriousness of Fournier gangrene when it occurs in people with diabetes.
By comparison, only 19 cases of Fournier gangrene were reported in patients using other diabetes medications over a much longer period—spanning from 1984 to January 2019.
This suggests that the infection might be a specific concern for those taking SGLT2 inhibitors, making it a newly recognized safety issue for these drugs.
The researchers behind the study emphasize the importance of doctors being aware of this risk. They suggest that healthcare providers monitor patients closely and educate them about symptoms to watch for, such as pain, swelling, or unusual redness in the genital or surrounding areas.
Early detection and prompt treatment are crucial to managing Fournier gangrene effectively and preventing serious outcomes.
The findings were published in the journal Annals of Internal Medicine and led by Susan J. Bersoff-Matcha and her team.
While SGLT2 inhibitors remain an important option for diabetes management, this research highlights the need for caution and awareness of potential complications. Patients using these drugs should discuss any concerns with their doctors to ensure they are informed and vigilant about their health.
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