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  • If atrial fibrillation develops, Rx 'Omega-3' API
  • by Lee, Hye-Kyung | translator Hong, Ji Yeon | Jan 23, 2025 05:54am
use should be discontinued
MFDS will reflect the safety information¡¦changes will be made to the approval specification starting February 10
 ¡ã Product photo of Kuhnil
The administration of the active ingredient 'omega-3-acid ethyl esters90,' which is used for treating dyslipidemia, will be permanently discontinued if a patient develops atrial fibrillation.

Starting February 10, the Ministry of Food and Drug Safety (MFDS) will modify the approval specification based on the results of the European Medicines Agency (EMA)'s safety assessment and monitoring of 'omega-3-acid ethyl esters90.'

Last year, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) agreed to add atrial fibrillation (irregular, rapid contraction of the heart) as a common side effect to the product information for medicines containing omega-3.

The review result of a Periodic Safety Update Single Asses
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