A new study by the U.S. Food and Drug Administration (FDA), published in the Annals of Internal Medicine, has raised concerns about a rare but dangerous infection linked to a newer type of diabetes medication called SGLT2 inhibitors.
These drugs are commonly used to help people with diabetes lower their blood sugar levels.
SGLT2 inhibitors work differently from older diabetes drugs. Instead of changing how the body uses insulin, they help remove extra sugar through the urine. This method has been effective for many patients, offering better blood sugar control. But like all medications, they come with risks—and this new research has identified one that is especially serious.
The FDA reviewed the medical records of patients taking SGLT2 inhibitors and found 55 cases of a life-threatening infection called Fournier gangrene between March 2013 and January 2019.
This infection affects the tissues around the genital and anal areas, can spread quickly, and requires urgent medical treatment. The patients in these cases ranged in age from 33 to 87, and included 39 men and 16 women.
The infection developed at different times after starting the medication—some patients became ill just 5 days after beginning treatment, while others showed symptoms more than four years later. Many of these patients also had other serious health problems like diabetic ketoacidosis, sepsis, and kidney damage, which made treatment more challenging.
To compare, the FDA looked at other diabetes medications such as metformin and insulin. From 1984 to January 2019, only 19 cases of Fournier gangrene were linked to these older drugs. This suggests that the risk may be higher for people taking SGLT2 inhibitors.
Because of these findings, doctors are being advised to monitor patients closely when they start SGLT2 inhibitors—especially during the first weeks or months. This early attention can help catch and treat infections before they become severe.
For patients, this means being alert to warning signs such as swelling, pain, or discomfort in the genital or anal area. If any of these symptoms appear, it’s important to contact a doctor immediately.
This study is a reminder that while SGLT2 inhibitors can be very effective in managing blood sugar, there are risks that must be considered. Both patients and healthcare providers should weigh the benefits against the potential dangers before deciding on treatment.
Ongoing research and monitoring are essential for all medications, especially newer ones. As more people use SGLT2 inhibitors, continued safety checks will help ensure they remain a safe option for diabetes care.
If you care about diabetes, please read studies about New diabetes drug could control blood sugar and body weight better and findings of Common diabetes drugs linked to increased heart risk.
For more about diabetes, please read studies about Why diabetes drug metformin can help increase longevity and findings of This drug could manage type 2 diabetes for a long time.
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