Medicosnext
The European Medicines Agency (EMA) has issued a Direct Health-care Professional Communication (DHPC) to alert healthcare professionals about a dose-dependent risk of atrial fibrillation (AF) associated with omega-3-acid ethyl esters. The warning highlights that patients with established cardiovascular diseases or risk factors face a higher risk of AF when treated with these medications compared to those receiving a placebo. The risk appears to be most significant at doses of 4 grams per day.
Omega-3-acid ethyl esters are commonly prescribed to lower triglyceride levels in patients who do not achieve adequate results through diet and lifestyle changes alone. Despite their effectiveness in managing hypertriglyceridemia, recent assessments by the Pharmacovigilance Risk Assessment Committee (PRAC) have raised concerns. The committee reviewed extensive data from systematic reviews and meta-analyses of randomized controlled trials involving over 80,000 patients. These studies showed a clear link between higher doses of omega-3 fatty acids and an increased incidence of AF.
Healthcare professionals are advised to inform patients about the symptoms of atrial fibrillation, including light-headedness, fatigue, palpitations, and shortness of breath. If any of these symptoms occur, patients should seek medical attention promptly. In cases where atrial fibrillation is diagnosed, discontinuation of omega-3-acid ethyl ester treatment is recommended to prevent further complications.
Reference: https://www.who.int/publications/i/item/9789240096233
