A group of diabetes medications that has become increasingly popular in recent years may carry a rare but very serious health risk, according to a new study from the U.S. Food and Drug Administration (FDA).
Researchers found that drugs known as SGLT2 inhibitors may be linked to a dangerous infection called Fournier gangrene, a fast-moving condition that can become life-threatening if not treated quickly.
SGLT2 inhibitors are a newer class of medications used to help people with type 2 diabetes control their blood sugar levels. The full name of these drugs is sodium-glucose cotransporter-2 inhibitors.
They work differently from many older diabetes medications because they help the body remove extra sugar through urine instead of simply increasing insulin levels.
Over the past decade, these drugs have become widely used because they offer several benefits beyond lowering blood sugar. Many patients taking SGLT2 inhibitors also experience modest weight loss and improvements in blood pressure.
Some studies have even shown that these medications can reduce the risk of heart failure and kidney disease in certain people with diabetes.
Common SGLT2 inhibitors include canagliflozin, dapagliflozin, and empagliflozin. Doctors often prescribe them when diet, exercise, and other medications are not enough to keep blood sugar under control.
But while these drugs can help many patients, the new FDA research highlights an important safety concern that both doctors and patients need to understand.
The FDA researchers reviewed reports of side effects linked to diabetes medications. They compared SGLT2 inhibitors with several other common treatments for diabetes, including metformin and insulin.
The scientists discovered 55 reported cases of Fournier gangrene in people taking SGLT2 inhibitors between 2013 and early 2019. The patients ranged in age from 33 to 87 years old. Most of the patients were men, with 39 male cases and 16 female cases reported.
Fournier gangrene is a rare but severe bacterial infection that affects the skin, fat, and tissue around the genital area and perineum, the area between the genitals and anus. The infection spreads rapidly and destroys tissue as it grows. Without urgent treatment, it can lead to severe illness, organ failure, or death.
The condition usually begins with symptoms such as pain, tenderness, swelling, redness, or warmth in the genital or lower body area. Patients may also develop fever, weakness, or a general feeling of being very unwell. Because the infection spreads quickly, emergency surgery is often needed to remove damaged tissue and stop the infection from worsening.
The study found that the infection appeared at very different times after patients started using SGLT2 inhibitors. Some people developed the condition within only five days of starting treatment, while others developed it more than four years later.
Many of the affected patients also suffered from other serious medical problems at the same time. These included diabetic ketoacidosis, a dangerous complication where the body produces high levels of acids called ketones because there is not enough insulin available.
Some patients also developed sepsis, a severe body-wide infection that can be deadly, as well as kidney injury.
To better understand the significance of the findings, the researchers compared the results with reports linked to older diabetes medications.
Between 1984 and early 2019, only 19 cases of Fournier gangrene were reported among patients taking other types of diabetes drugs. Considering that this period covered several decades, the much higher number of cases linked to SGLT2 inhibitors raised concern among researchers.
Although Fournier gangrene is extremely rare, the seriousness of the infection means doctors must pay close attention to warning signs. Early diagnosis and treatment are critical for survival.
The FDA emphasized that patients should not suddenly stop taking their medication because uncontrolled diabetes itself can cause many severe complications, including heart disease, kidney failure, blindness, nerve damage, and stroke.
Instead, patients taking SGLT2 inhibitors should speak with their healthcare provider if they notice unusual symptoms, especially pain, swelling, redness, or tenderness around the genital or lower body area.
Doctors may decide that the benefits of the medication still outweigh the risks for many patients. SGLT2 inhibitors remain valuable drugs because they can improve blood sugar control and protect the heart and kidneys in some individuals.
However, the findings show the importance of regular monitoring and open communication between patients and healthcare professionals.
The study also serves as a reminder that all medications can have side effects, even drugs that provide major benefits. As newer treatments become more widely used, rare complications sometimes become easier to detect because larger numbers of people are taking the medications.
Researchers continue studying SGLT2 inhibitors to better understand who may be most at risk for this infection and whether certain patients should avoid these drugs altogether. Future studies may also help doctors identify ways to lower the risk while still allowing patients to benefit from the medications.
For now, experts say awareness is the most important tool. Recognizing symptoms early and seeking immediate medical attention could save lives.
The study was conducted by researchers from the U.S. Food and Drug Administration (FDA).
If you care about diabetes, please read studies about diabetes and vitamin B12, and the right diet for people with type 2 diabetes.
For more health information, please see recent studies about how to eat smart with diabetes, and turmeric and vitamin D: a duo for blood pressure control in diabetic patients.
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