A recent study by the U.S. Food and Drug Administration (FDA) has raised concerns about a class of diabetes drugs called SGLT2 inhibitors.
These medications, which have been praised for their ability to manage blood sugar levels in people with type 2 diabetes, are now linked to a rare but severe infection known as Fournier gangrene.
Published in the Annals of Internal Medicine, the study analyzed health data from diabetic patients using various medications. It identified 55 cases of Fournier gangrene among those taking SGLT2 inhibitors between March 2013 and January 2019. The affected patients ranged in age from 33 to 87 years, including 39 men and 16 women.
Fournier gangrene is a serious bacterial infection that affects the external genitalia, perineum, and surrounding areas. The infection can progress rapidly and is considered a medical emergency. In the study, the infection occurred between 5 days and 49 months after patients started using SGLT2 inhibitors.
Complications for these patients extended beyond the infection itself. Many also experienced diabetic ketoacidosis (a dangerous buildup of acids in the blood), sepsis (a life-threatening response to infection), and kidney injury.
To put this risk into perspective, the study also looked at data from patients using other diabetes medications, such as metformin, insulin glargine, short-acting insulin, and newer drugs like sitagliptin plus metformin and dulaglutide.
Over a much longer timeframe (1984 to January 2019), only 19 cases of Fournier gangrene were reported among users of these other medications.
The significant difference in the number of cases highlights a newly recognized risk associated with SGLT2 inhibitors. While the overall risk of Fournier gangrene remains low, the findings suggest that patients taking these drugs should be monitored more closely.
Doctors prescribing SGLT2 inhibitors are urged to educate their patients about this potential complication and watch for early signs of infection, particularly during the first weeks or months of treatment.
For patients with diabetes, this study serves as a reminder of the importance of being informed about the risks and benefits of their medications.
While SGLT2 inhibitors are effective in controlling blood sugar levels, it’s crucial to remain vigilant for any unusual symptoms, such as pain, swelling, or redness in the genital or perineal area, fever, or general feelings of being unwell. Early detection and treatment of infections can prevent more severe complications.
This research is part of an ongoing effort to better understand the safety of newer diabetes medications. The findings emphasize the need for continued monitoring and research to ensure that these drugs are both effective and safe for long-term use.
For individuals managing diabetes, this study underscores the importance of open communication with healthcare providers. Discussing treatment options, understanding potential risks, and promptly addressing any concerns can help ensure better outcomes and safer care.
If you care about diabetes, please read studies about a cure for type 2 diabetes, and these vegetables could protect against kidney damage in diabetes.
For more information about diabetes, please see recent studies about bone drug that could lower risk of type 2 diabetes, and results showing eating more eggs linked to higher risk of type 2 diabetes.
Copyright © 2025 Knowridge Science Report. All rights reserved.
