Widely used diabetes drug linked to rare, serious infection

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Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a newer type of medication used to help people with diabetes manage their blood sugar levels. They work by helping the body get rid of extra sugar through urine. These drugs have become popular because they are effective and can also help with weight loss and heart health in some patients.

However, a new study by the U.S. Food and Drug Administration (FDA) has found a rare but serious risk connected to SGLT2 inhibitors: a dangerous infection called Fournier gangrene. This infection affects the skin and tissue around the genitals and perineum (the area between the genitals and the anus) and can be life-threatening if not treated quickly.

In the study, FDA researchers looked at several diabetes medications, including SGLT2 inhibitors, metformin, insulin, and other common treatments. They were checking for any harmful side effects linked to these drugs.

They found that between 2013 and early 2019, there were 55 cases of Fournier gangrene in people taking SGLT2 inhibitors. The patients were between 33 and 87 years old, with more men affected than women (39 men and 16 women).

The infection showed up at different times—anywhere from just 5 days to over 4 years after the person started taking the medication. In many cases, the patients also experienced other serious health issues at the same time, such as diabetic ketoacidosis (a dangerous condition when the body doesn’t have enough insulin), severe infections like sepsis, and kidney damage.

To put this into perspective, over a much longer period—from 1984 to early 2019—only 19 cases of this infection were reported in people using other types of diabetes drugs. This difference suggests that SGLT2 inhibitors may be more strongly linked to the risk of Fournier gangrene than other diabetes treatments.

Fournier gangrene is rare, but when it does occur, it can be deadly. It usually starts with pain, swelling, or redness in the genital area. If it’s not caught early, it can spread quickly and require emergency surgery. That’s why it’s so important for doctors and patients to be aware of the warning signs and act fast if anything seems wrong.

Despite this risk, SGLT2 inhibitors are still very helpful for many people with diabetes. They can improve blood sugar control and even lower the risk of some heart and kidney problems. But this study is a reminder that no drug is perfect, and all medications have risks as well as benefits.

If you are taking an SGLT2 inhibitor, such as canagliflozin, dapagliflozin, or empagliflozin, don’t stop taking it suddenly — but do talk to your doctor if you have any concerns or notice unusual symptoms, especially pain or swelling in the lower body. Your doctor can help decide if the medication is still right for you or if another treatment would be safer.

In short, this study highlights an important safety issue that both doctors and patients need to be aware of. Careful monitoring and early action can make a big difference. The goal is always to manage diabetes effectively while keeping risks as low as possible.

If you care about diabetes, please read studies about Vitamin D and type 2 diabetes, and to people with diabetes, some fruits are better than others.

For more health information, please see recent studies that low calorie diets may help reverse diabetes, and 5 vitamins that may prevent complication in diabetes.

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