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  • 734 SGLT2is add precautions for ketoacidosis
  • by Lee, Hye-Kyung | translator Alice Kang | Mar 10, 2025 05:50am
MFDS collects opinions on labeling changes by the 20th
for Ertugliflozin, Empagliflozin, and Dapagliflozin
 ¡ã SGLT-2 inhibitors approved in Korea
Precautions for antidiabetic SGLT2 inhibitors will be strengthened in the near future.

734 ertugliflozin, empagliflozin, and dapagliflozin drugs that have been approved in Korea are expected to be subject to the changed regulations.

The Ministry of Food and Drug Safety will prepare an ¡®Order for labeling changes (draft)¡¯ based on the safety information of SGLT2 inhibitors by the 20th of this month and conduct an opinion inquiry thereafter.

This draft order for changes was made based on the 'Results of the review of safety information on SGLT2 inhibitor-related drugs' by Health Canada (HC) and the US Food and Drug Administration (FDA).

Representative products include AstraZeneca Korea's ¡®Sidapvia Tab (d
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