A new study has shown that a group of diabetes drugs called SGLT2 inhibitors may increase the risk of a rare but dangerous infection.
This infection is known as Fournier gangrene. It affects the skin and tissues near the private parts and the area between the genitals and anus. If not treated quickly, it can become life-threatening.
The study was done by researchers from the U.S. Food and Drug Administration (FDA). They wanted to check the safety of SGLT2 inhibitors. These drugs are used by people with type 2 diabetes to help control blood sugar levels.
The researchers looked at how SGLT2 inhibitors compared to other common diabetes drugs like metformin, insulin, and other medicines. Between March 1, 2013, and January 31, 2019, they found 55 people who got Fournier gangrene while taking SGLT2 inhibitors. These patients were between 33 and 87 years old. There were 39 men and 16 women.
The infection could appear very fast — in some people, symptoms started just five days after taking the drug. In others, it took up to four years. Many of the patients also had other serious problems caused by diabetes, such as diabetic ketoacidosis (where the blood becomes too acidic), infections in the blood (sepsis), or kidney problems.
In comparison, from 1984 to 2019, only 19 cases of Fournier gangrene were reported in people taking other diabetes drugs. This shows that the risk of this infection is much higher for those using SGLT2 inhibitors.
The researchers said that Fournier gangrene is now a new safety concern for these drugs. They advised doctors to be aware of the signs and to watch patients closely. Catching the infection early is very important because it can be treated more easily in the beginning. If it’s missed, the infection can spread fast and lead to serious health problems or even death.
The study was led by Dr. Susan J. Bersoff-Matcha and was published in the Annals of Internal Medicine. The researchers highlighted how important it is for doctors to talk to patients about possible risks when starting SGLT2 inhibitors.
People taking these drugs should watch out for any pain, redness, swelling, or tenderness around the genitals or nearby areas. If they notice anything strange, they should see a doctor right away. Quick treatment can save lives.
Even though SGLT2 inhibitors help many people by lowering blood sugar and protecting the heart and kidneys, this study is a reminder. Both doctors and patients need to balance the good effects of the drug with the possible risks.
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