FDA links popular diabetes drugs to rare but serious infection

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A newer type of diabetes medication called sodium-glucose cotransporter-2 (SGLT2) inhibitors has been linked to a rare but very serious infection called Fournier gangrene.

This infection affects the area around the genitals, including the skin between the genitals and the anus (called the perineum). It spreads quickly and can become life-threatening if not treated right away.

Researchers from the U.S. Food and Drug Administration (FDA) recently studied the risks of SGLT2 inhibitors compared to other common diabetes drugs. They looked at medical records of people who were taking various diabetes medications, including metformin, different types of insulin, and other popular treatments like sitagliptin and dulaglutide.

Between March 2013 and January 2019, they found 55 cases of Fournier gangrene in people using SGLT2 inhibitors. The patients ranged in age from 33 to 87 years old. There were 39 men and 16 women who developed the condition.

The infection didn’t always appear right after people started taking the medication. For some, it showed up within just five days. For others, it appeared nearly four years later. This shows that the risk could appear at any time while using the drug.

Many of the patients who got Fournier gangrene also experienced other serious diabetes-related problems. These included diabetic ketoacidosis (a dangerous condition caused by high levels of acid in the blood), sepsis (a life-threatening reaction to infection), and kidney damage.

To understand how unusual this risk might be, the researchers also looked at cases of Fournier gangrene in people using older diabetes medications between 1984 and 2019. Over that longer time period, they found only 19 cases. This suggests that SGLT2 inhibitors may be linked to a higher risk of this rare infection than other diabetes treatments.

Because of this, the FDA researchers now consider Fournier gangrene a newly recognized safety concern for people using SGLT2 inhibitors. They recommend that doctors who prescribe these drugs should watch for signs of infection and act quickly if symptoms appear.

Fournier gangrene is a medical emergency. Early signs can include pain, swelling, or redness in the genital or anal area, fever, or feeling very unwell. If caught early, the infection can be treated and the risk of serious harm or death can be reduced.

The study was led by Dr. Susan J. Bersoff-Matcha and published in the *Annals of Internal Medicine*. It highlights the need to carefully weigh the benefits and risks of new diabetes treatments. While SGLT2 inhibitors can be helpful in controlling blood sugar and preventing heart and kidney problems, doctors and patients should stay alert for rare but serious side effects.

Anyone using these medications should speak with their doctor if they notice any unusual symptoms. Staying informed and taking action early can make a big difference in staying safe.

If you care about diabetes, please read studies about Why diabetes drug metformin can help increase longevity and findings of This drug could manage type 2 diabetes for a long time.

For more information about diabetes, please read studies about Potatoes: friend or foe in the battle against diabetes? and findings of This blood pressure drug may protect kidney health in people with diabetes.

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