The Ministry of Food and Drug Safety said it has recently confirmed the side effect of sodium glucose co-transporter-2 (SGLT-2) resulting in the occurrence of the perineal necrosis.
After examining the safety information from the U.S. Food and Drug Administration, the ministry decided to add the side effect to the general cautionary note.
The ministry noted the licensing changes were due to a rare but life-threatening severe perineal gangrene in diabetic patients taking the SGLT-2 formulation, and, in some cases, the patient's conditions were so grave as to require a prompt operation.
Both male and females patients taking the SGLT-2 formulation are in need of caution as men and women had cases of perineal gangrene.
Perineal gangrene is a severe infection that causes necrosis of nearby skin tissues, including genitalia. Although recent medical technology development has lowered the mortality rate of the disease, it remains high at 30 percent, so early diagnosis is still necessary as the disease progresses fast, it said.
Suspected cases of perineal necrosis include pain, edema, or high fever above 38 degrees when directly pressing the genital organs.
"If a patient taking SGLT-2 is suffering from fever, discomfort, pain, rash, erythema or edema around the genitals or perineum, they should immediately get their symptoms checked,” a ministry official said. “If the perineal necrosis is suspected, medical workers should start immediate broad-spectrum antibiotic therapy, and perform surgical resection if necessary.”
The official said the patients should also stop taking any SGLT-2 drugs, adding that the ministry would seek opinions from the industry until Jan. 28.
Opinion inquiries are the last procedure after the ministry decides to change the permit. If there is no significant opposition from the industry, the side effects will be officially recognized and become permanent.
In Korea, there are currently 22 SGLT-2 products made from five substances -- Forxiga (AstraZeneca), Invokana (Janssen), Jardiance (Boehringer Ingelheim), Suglat (Astellas Pharma) and Steglatro (MSD).
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