Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)

28. September 2023 – The 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-acid ethyl esters. These medicines are indicated for the treatment of hypertriglyceridaemia, when a modification of diet and lifestyle alone are not sufficient to bring down levels of triglyceride, a type of fat, in the blood. Hypertriglyceridemia is a risk factor for coronary artery disease. Patients on these medications often have other conditions such as cardiovascular diseases and diabetes.

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