Widely used diabetes drugs linked to serious infection

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A recent study has found that a class of diabetes drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors may increase the risk of a rare but serious bacterial infection known as Fournier gangrene. This infection affects the external genitalia, perineum, and perianal region and can lead to severe complications if not treated early.

Researchers from the U.S. Food and Drug Administration (FDA) examined the health risks of SGLT2 inhibitors and compared them to other diabetes medications, including metformin, insulin glargine, short-acting insulin, sitagliptin combined with metformin, and dulaglutide.

Their findings showed that between March 1, 2013, and January 31, 2019, there were 55 documented cases of Fournier gangrene in diabetic patients taking SGLT2 inhibitors.

The patients affected ranged in age from 33 to 87 years, with 39 men and 16 women included in the cases. The time between starting the medication and developing the infection varied widely, from as little as five days to as long as 49 months. Many of these patients also experienced other serious diabetes-related complications, such as diabetic ketoacidosis, sepsis, and kidney injury.

In contrast, the study found only 19 cases of Fournier gangrene in patients taking other diabetes drugs over a much longer period, from 1984 to January 2019. This suggests that the risk of infection is significantly higher in those using SGLT2 inhibitors.

The researchers highlighted that this infection is a newly recognized safety concern for people taking SGLT2 inhibitors. They recommend that doctors be aware of this potential risk and monitor patients closely for early signs of infection. Early detection and treatment are critical to preventing severe complications.

The study, conducted by Susan J. Bersoff-Matcha and her team, was published in the Annals of Internal Medicine. These findings underscore the importance of careful monitoring and patient education when prescribing SGLT2 inhibitors for diabetes management.

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