If you’ve ever considered taking fish oil supplements for your heart health, it’s time to pay close attention. The European Medicines Agency (EMA) has just issued a warning about a side effect linked with omega-3 fatty acid medications aka Fish Oil. EMA confirms atrial fibrillation (AF) as a side effect of fish oil supplements. It is a significant finding in cardiovascular medicine.
Atrial Fibrillation – The Newly Identified Risk
Fish oil supplements are a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) at a daily dose of 1 g. These have long been considered a potential boon for cardiovascular health. However, the latest findings from the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) shed new light on their safety.
Atrial fibrillation is a heart rhythm disorder characterized by irregular and often rapid heartbeats. Now it is officially recognized as a common side effect of medicinal products containing omega-3-acid ethyl esters. EMA highlights that if atrial fibrillation develops as a result of taking these medications, their use must be permanently discontinued.
❗ Atrial fibrillation will now be included as a common side effect in the Summary of Product Characteristics for medicinal products containing omega-3-acid ethyl esters. #AFIB #omega3 https://t.co/kLjFomcT7R— Medscape (@Medscape) October 13, 2023
A Shift in Treatment Guidelines
The uses of these new findings are significant. Especially for those who have previously relied on fish oil supplements for secondary prevention after a heart attack.
The EMA’s decision derives from a strict review of available data. They have even reviewed the original ‘GISSI Prevenzione study from 1999. This initial study supports the use of these supplements for post-heart attack care. But there is a change in the game now.
However, the re-examination that followed revealed how these supplements are not effective in preventing blood vessel problems in patients who have had a heart attack. As a result, the use of omega-3 fatty acid medicines for secondary prevention after myocardial infarction is no longer allowed.
The Silver Lining
This change in authorization only applies to their use for secondary prevention after a heart attack. Fish oil supplements still hold value in another important aspect of cardiovascular health. Especially in the management of hypertriglyceridemia.
Hypertriglyceridemia is known by an increase in the levels of a certain type of blood fat called triglycerides. It acts as a significant risk factor for coronary heart disease. However, Omega-3 fatty acid medicines containing EPA and DHA are still authorized and considered effective in reducing triglyceride levels.
What Should You Do?
If you’ve been using omega-3 fatty acid medicines to prevent further heart problems after a heart attack, it’s a must to consult your doctor. They can guide you toward alternative treatment options that are more appropriate.
On the other hand, if you’ve been taking these supplements to manage triglyceride levels, you can continue your treatment without concerns. The EMA’s update does not raise any new safety issues related to the use of omega-3 medicines.
At its monthly meeting, EMA's safety committee discussed new safety information for #medicines containing omega-3-acid ethyl esters.— EU Medicines Agency (@EMA_News) September 29, 2023
More information in our meeting highlights: https://t.co/TlEbtXuhPK#SafetyOfMedicines #PRAC pic.twitter.com/yuZMVLWWEr
The EMA’s recent warning regarding atrial fibrillation as a side effect of fish oil supplements is a significant development in cardiovascular medicine. While these medicines may no longer be used for secondary prevention after a heart attack, they remain a valuable tool in keeping good heart health.