New Safety Information for Omega-3-Acid Ethyl Esters: dose-dependent increased risk of atrial fibrillation

The Pharmacovigilance Risk Assessment Committee (PRAC) convened from September 25th to 28th, 2023, to review critical safety data. Among the significant outcomes was the decision to update the product information for medicines containing Omega-3-acid ethyl esters.


Atrial Fibrillation Identified as a Common Side Effect


The PRAC has endorsed the addition of atrial fibrillation - characterized by irregular, rapid contractions of the heart - to the list of common side effects associated with medicines containing Omega-3-acid ethyl esters. These medications are prescribed for the management of hypertriglyceridemia, a condition in which dietary and lifestyle modifications alone are insufficient to regulate levels of triglycerides in the blood.

Notably, hypertriglyceridemia poses a risk factor for coronary artery disease, and patients on these medications often grapple with concurrent conditions such as cardiovascular diseases and diabetes.


Evidence-Based Decision Making


The PRAC based its decision on a thorough examination of systematic reviews and meta-analyses of randomized controlled clinical trials. These analyses revealed a dose-dependent increase in the risk of atrial fibrillation among patients with established cardiovascular diseases or cardiovascular risk factors who were treated with Omega-3-acid ethyl esters as compared to those who received a placebo.

The highest observed risk was associated with a daily dose of 4 grams. Importantly, if atrial fibrillation does develop, treatment with these medicines should be permanently discontinued.


Informing Healthcare Professionals and Patients


In light of these findings, the PRAC has recommended an update to the product information to ensure that healthcare professionals and patients are informed about the risk of atrial fibrillation. A Direct Healthcare Professional Communication (DHPC) will be dispatched shortly to furnish doctors with further details.


Next Steps


Upon adoption, this DHPC will be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). Subsequently, following the CMDh's opinion, the DHPC will be distributed to healthcare professionals by the marketing authorization holder, in accordance with an agreed-upon communication plan. It will also be made available on the Direct Healthcare Professional Communications page and in national registers across EU Member States.


This decision underscores the PRAC's commitment to patient safety and its dedication to ensuring that the benefits of medications outweigh any potential risks. Healthcare professionals are encouraged to stay vigilant for updates and to incorporate this critical information into their practice.


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