Medicines called SGLT2 inhibitors have become one of the most important treatments for people with type 2 diabetes. These drugs lower blood sugar in a different way from many older diabetes medicines.
Instead of helping the body produce more insulin, they allow extra sugar to leave the body through the urine. Because of this, they can improve blood sugar control and have also been shown to protect the heart and kidneys in many patients. These benefits have made SGLT2 inhibitors widely used around the world.
Like all medicines, however, they can cause side effects. Most side effects are mild, but a study by the U.S. Food and Drug Administration (FDA) has highlighted a very rare but serious complication that both doctors and patients should know about.
The findings raise awareness of a dangerous infection called Fournier gangrene, which requires immediate medical treatment.
The FDA study examined the safety of several diabetes medicines, including SGLT2 inhibitors, metformin, insulin products, and combination treatments. The researchers wanted to identify uncommon but severe health problems that might be linked to these medications.
One of the most important findings involved Fournier gangrene. This is a rare bacterial infection that attacks the skin and soft tissues around the genitals and the area between the genitals and anus, known as the perineum. Although uncommon, it spreads very quickly and can become life-threatening if treatment is delayed.
The infection often begins with pain, tenderness, redness, or swelling in the affected area. People may also develop fever, chills, tiredness, or generally feel very unwell.
Because the infection destroys tissue rapidly, patients usually need emergency hospital care. Treatment often includes powerful antibiotics, surgery to remove infected tissue, and intensive medical support. Without prompt treatment, the condition can become fatal.
The FDA identified 55 cases of Fournier gangrene in people taking SGLT2 inhibitors between March 2013 and January 2019. The patients ranged from 33 to 87 years of age. Thirty-nine were men and sixteen were women, showing that although the condition is more common in men, women can also be affected.
For comparison, the FDA found only 19 similar cases among people using other diabetes medications during a much longer period extending from 1984 to early 2019. While this does not prove that SGLT2 inhibitors directly cause the infection, it suggests there may be an increased risk associated with this class of medicines.
The study also found that the infection could develop at very different times after treatment began. Some patients became ill within only a few days of starting the medication, while others developed the infection more than four years later. This means patients and healthcare professionals should remain alert throughout treatment, not only during the first few weeks.
Many of the affected patients also experienced other serious medical problems, including diabetic ketoacidosis, a dangerous condition caused by high levels of acids called ketones in the blood. Some developed sepsis, a severe body-wide infection, while others suffered kidney injury. These complications can make treatment even more difficult and increase the risk of death.
Despite these findings, experts stress that people should not stop taking SGLT2 inhibitors without first speaking with their doctor. These medicines provide important health benefits for many people with type 2 diabetes.
In addition to lowering blood sugar, they reduce the risk of heart failure, help protect kidney function, and lower the risk of serious cardiovascular events in many high-risk patients.
Instead, the findings highlight the importance of education and early recognition. Patients should know the warning signs of Fournier gangrene and seek urgent medical care if they develop pain, swelling, redness, or tenderness around the genital or perineal area, especially if these symptoms occur together with fever or feeling seriously unwell.
Researchers continue to study why this rare infection occurs in some people taking SGLT2 inhibitors and whether certain patients are more likely to develop it. Better understanding these risk factors may help doctors prevent future cases while allowing patients to continue benefiting from these valuable medicines.
The FDA study reminds us that every medication has both benefits and risks. Careful monitoring, good communication between patients and healthcare providers, and prompt medical attention when unusual symptoms appear are the best ways to use these medicines safely while continuing to gain their proven benefits.
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The study was conducted by the U.S. Food and Drug Administration (FDA).
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