In a new study, FDA researchers found a new diabetes drug could lead to a type of infection in the body, including external genitalia, perineum, and perianal region.
The new drug is called sodium–glucose cotransporter-2 (SGLT2) inhibitors, and the infection is called Fournier gangrene.
In the study, the team examined the health risks of SGLT2 inhibitor and other diabetes drugs.
The FDA identified 55 cases of this infection in diabetic patients using SGLT2 inhibitors between 1 March 2013 and 31 January 2019.
The patients ranged in age from 33 to 87 years. Among them, 39 were men, and 16 were women.
The onset of infections ranged from 5 days to 49 months after the patients used SGLT2 inhibitors.
These people also experienced several other diabetic complications, including diabetic ketoacidosis, sepsis, and kidney injury.
On the contrary, the FDA found only 19 cases of the infection in patients using other diabetes drugs between 1984 and 31 January 2019.
These other diabetes drugs include metformin, insulin glargine, short-acting insulin, sitagliptin plus metformin, and dulaglutide.
The team suggests that the infection is a newly identified safety concern in diabetic patients receiving SGLT2 inhibitors.
Doctors who prescribe this type of drug should be aware of this possible complication and try to detect it in its early stages.
The lead author of the study is Susan J. Bersoff-Matcha, MD.
The study is published in Annals of Internal Medicine.
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