A newer class of diabetes drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors has been linked to a rare but life-threatening infection known as Fournier gangrene.
This condition affects the external genitalia, the area between the genitals and anus (perineum), and the perianal region. It spreads quickly and requires immediate medical treatment.
Researchers from the U.S. Food and Drug Administration (FDA) recently investigated the risks associated with SGLT2 inhibitors compared to other diabetes medications. They analyzed medical records of patients taking different diabetes treatments, including metformin, insulin glargine, short-acting insulin, sitagliptin plus metformin, and dulaglutide.
Between March 2013 and January 2019, the study identified 55 cases of Fournier gangrene among people using SGLT2 inhibitors. The affected patients ranged in age from 33 to 87, with 39 men and 16 women diagnosed.
The infection appeared at unpredictable times—some developed it within just five days of starting the medication, while others were affected as late as 49 months after beginning treatment.
Patients with Fournier gangrene often experienced additional severe complications common in diabetes, such as diabetic ketoacidosis (a dangerous build-up of acid in the blood), sepsis (a life-threatening infection response), and kidney damage.
For comparison, researchers reviewed cases of Fournier gangrene in patients taking other diabetes drugs from 1984 to 2019. Over this much longer period, only 19 cases were found. This suggests that SGLT2 inhibitors may pose a greater risk of developing this serious infection compared to older diabetes medications.
The researchers identified Fournier gangrene as a newly recognized safety concern for patients using SGLT2 inhibitors. Given the severity of the condition, doctors prescribing these drugs should be aware of the risk and watch for early signs of infection in their patients. Early diagnosis and treatment can prevent the infection from spreading and becoming fatal.
The study, led by Susan J. Bersoff-Matcha, was published in the Annals of Internal Medicine. It highlights the importance of balancing the benefits and risks of newer diabetes treatments and staying alert to potential side effects.
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