Medicines known as sodium-glucose cotransporter-2 (SGLT2) inhibitors have become an important treatment for people with type 2 diabetes.
These medicines lower blood sugar by helping the kidneys remove extra glucose through urine. In addition to improving blood sugar control, they can also help some people lose weight and reduce the risk of heart and kidney disease.
Although these medicines offer important health benefits, researchers continue to monitor their safety after they become widely used. A study by scientists at the U.S. Food and Drug Administration (FDA) has identified a rare but potentially life-threatening side effect that patients and healthcare professionals should know about.
The researchers investigated reports of a serious infection called Fournier gangrene. This rare infection affects the skin and soft tissues around the genitals and the area between the genitals and the anus. It spreads quickly and requires urgent medical treatment, often including surgery and powerful antibiotics.
The FDA team reviewed reports involving several different diabetes medicines, including SGLT2 inhibitors, metformin, insulin, and other commonly prescribed treatments. They wanted to determine whether any medicines appeared to have a stronger link with this rare infection.
The researchers found 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, with 39 men and 16 women affected. Symptoms appeared anywhere from five days to more than four years after treatment began.
Many of the patients also experienced other serious medical problems, including diabetic ketoacidosis, severe bloodstream infections known as sepsis, and kidney injury. These complications show how dangerous the infection can become if it is not recognized and treated quickly.
For comparison, only 19 cases of Fournier gangrene had been reported in people taking other diabetes medicines over a much longer period, from 1984 to early 2019. While this does not prove that SGLT2 inhibitors directly cause the infection, it suggests there may be a stronger association than with older diabetes treatments.
Fournier gangrene is extremely uncommon, but it is considered a medical emergency. Early warning signs may include pain, swelling, redness, or tenderness around the genital or perineal area, often together with fever or feeling generally unwell. Prompt treatment greatly improves the chances of recovery.
Despite these findings, experts emphasize that SGLT2 inhibitors remain valuable medicines for many people. Their benefits for controlling blood sugar and protecting the heart and kidneys often outweigh the small risk of this rare complication. Patients should never stop taking a prescribed medicine without first discussing it with their healthcare provider.
People taking medicines such as canagliflozin, dapagliflozin, or empagliflozin should seek immediate medical attention if they notice unusual pain, swelling, or redness in the genital area, especially if these symptoms are accompanied by fever or feeling very ill. Doctors can determine whether the medicine should be stopped and whether emergency treatment is needed.
The FDA study reminds us that every medicine has both benefits and risks. Careful monitoring, regular communication with healthcare providers, and early recognition of unusual symptoms can help people receive the benefits of diabetes treatment while keeping serious complications as rare as possible.
If you care about diabetes, please read studies about 5 vitamins that may prevent complication in diabetes, and how to manage high blood pressure and diabetes with healthy foods.
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