A new study has found that a group of diabetes drugs called SGLT2 inhibitors may increase the risk of a rare but dangerous bacterial infection known as Fournier gangrene.
This infection attacks the skin and tissue around the external genitals, the area between the genitals and anus (called the perineum), and the area around the anus. If not treated quickly, Fournier gangrene can cause very serious health problems and even death.
Researchers from the U.S. Food and Drug Administration (FDA) led the study to look at the safety of SGLT2 inhibitors. These drugs are used to help people with type 2 diabetes control their blood sugar levels.
The researchers compared SGLT2 inhibitors to other common diabetes medications, including metformin, insulin glargine, short-acting insulin, sitagliptin combined with metformin, and dulaglutide.
They found that between March 1, 2013, and January 31, 2019, there were 55 reported cases of Fournier gangrene in people taking SGLT2 inhibitors. The patients ranged in age from 33 to 87 years old. Out of the 55 cases, 39 were men and 16 were women.
The infection could develop very quickly, with some people getting sick just five days after starting the medication. For others, it took as long as 49 months after starting treatment.
Many of these patients also had other serious problems related to their diabetes, including diabetic ketoacidosis (a dangerous condition where the blood becomes too acidic), blood infections (sepsis), and kidney damage.
When the researchers looked at patients taking other types of diabetes medications, they found only 19 cases of Fournier gangrene over a much longer time period — from 1984 to January 2019. This shows that the risk of this rare infection is much higher in people using SGLT2 inhibitors compared to those taking other diabetes drugs.
The researchers explained that Fournier gangrene is now recognized as a new safety concern for people using SGLT2 inhibitors. They urged doctors to be aware of this risk and to watch their patients closely for any early signs of infection.
Catching Fournier gangrene early is very important because it can be treated more effectively if found quickly. Without early treatment, the infection can spread fast and cause life-threatening complications.
This study was led by Dr. Susan J. Bersoff-Matcha and her team and was published in the Annals of Internal Medicine. The results show how important it is for doctors to monitor patients carefully and to educate them about possible side effects when starting SGLT2 inhibitor therapy.
Patients taking these medications should pay attention to any pain, swelling, redness, or tenderness around the genitals or nearby areas and seek medical help immediately if they notice anything unusual. Early treatment can save lives.
While SGLT2 inhibitors have important benefits for managing blood sugar and even protecting heart and kidney health in many people with type 2 diabetes, this study reminds everyone — patients and doctors alike — that it’s important to balance the benefits with the risks.
If you care about diabetes, please read studies about the cooking connection between potatoes and diabetes, and low calorie diets may help reverse type 2 diabetes.
For more health information, please see recent studies about protein power: a new ally in diabetes management, and pineapple and diabetes: A sweet surprise.
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