"EMA Issues Warning on Omega-3-Acid Ethyl Esters Link to AF"
Originally Published 2 years ago — by Medscape
The European Medicines Agency (EMA) has confirmed that atrial fibrillation (AF) will now be listed as a common side effect of medicinal products containing omega-3-acid ethyl esters. The EMA's safety committee found a dose-dependent increase in the risk of AF in patients with cardiovascular diseases or risk factors who were treated with omega-3-acid ethyl esters. The highest risk was observed at a dose of 4 g/d. Physicians, pharmacists, and patients will be informed of this risk through an update to the product characteristics and a notification to healthcare professionals.