Medications known as SGLT2 inhibitors have become some of the most widely used treatments for type 2 diabetes.
Doctors often prescribe these drugs because they help lower blood sugar levels and offer additional benefits for the heart and kidneys.
For many people living with diabetes, these medicines have improved health outcomes and reduced the risk of serious complications.
However, a study conducted by the U.S. Food and Drug Administration (FDA) has identified a rare but potentially life-threatening side effect that patients and healthcare providers should be aware of.
SGLT2 inhibitors work differently from many other diabetes medications. Instead of helping the body produce more insulin, they lower blood sugar by causing the kidneys to remove excess glucose from the body through urine.
Several commonly prescribed medications belong to this group, including canagliflozin, dapagliflozin, and empagliflozin.
Although these drugs are generally considered safe and effective, the FDA study found a possible link between SGLT2 inhibitors and a severe infection called Fournier gangrene.
Fournier gangrene is a rare but extremely serious bacterial infection that affects the tissue around the genital and anal areas. The infection can spread rapidly and destroy healthy tissue within a short period of time. Without immediate medical treatment, it can become life-threatening.
The FDA reviewed reports involving several diabetes treatments, including SGLT2 inhibitors, metformin, insulin products, and combination medications. The goal was to identify serious adverse events that might be associated with these treatments.
During the investigation, researchers found 55 reported cases of Fournier gangrene among people taking SGLT2 inhibitors between March 2013 and January 2019. The patients ranged in age from 33 to 87 years old. Among these cases, 39 occurred in men and 16 occurred in women.
The findings were particularly concerning because the infection appeared much less frequently among users of other diabetes medications.
Between 1984 and early 2019, only 19 cases of Fournier gangrene were identified among people taking other types of diabetes drugs. This comparison suggests that SGLT2 inhibitors may be associated with a higher risk of developing the infection.
The timing of the infection varied greatly. Some patients developed Fournier gangrene within only a few days of starting treatment, while others did not experience symptoms until more than four years later. This indicates that the risk may remain present throughout treatment rather than being limited to the early stages of medication use.
Many of the affected patients also experienced other serious medical complications. Some developed diabetic ketoacidosis, a dangerous condition in which acids called ketones build up in the blood.
Others suffered from sepsis, a severe body-wide response to infection, or acute kidney injury. These complications can make treatment more difficult and increase the risk of poor outcomes.
Fournier gangrene usually begins with symptoms such as pain, swelling, tenderness, or redness in the genital or perineal area. Patients may also develop fever, fatigue, or a general feeling of illness. Because the infection progresses quickly, prompt medical attention is essential.
Treatment often involves emergency surgery to remove infected tissue, along with powerful antibiotics and supportive hospital care. Early diagnosis greatly improves the chances of recovery.
The FDA findings highlight the importance of balancing the benefits and risks of any medication. SGLT2 inhibitors remain valuable treatments for many people with type 2 diabetes.
In addition to lowering blood sugar, numerous studies have shown that they can reduce the risk of heart failure, slow the progression of kidney disease, and improve overall health outcomes in certain patients.
For this reason, experts do not recommend that patients stop taking these medications without consulting their healthcare provider. Instead, patients should be informed about the warning signs of Fournier gangrene and encouraged to seek medical care immediately if unusual symptoms develop.
The study also emphasizes the need for continued monitoring and research. Scientists still do not fully understand why some people taking SGLT2 inhibitors develop this infection while most do not. Learning more about the biological mechanisms involved could help doctors identify high-risk patients and develop strategies to prevent future cases.
The findings serve as an important reminder that even highly effective medications can sometimes have unexpected side effects. Careful monitoring, patient education, and ongoing research are essential to ensuring that diabetes treatments remain both effective and safe.
The study was conducted by the U.S. Food and Drug Administration and examined reported cases of Fournier gangrene associated with diabetes medications.
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