The conclusion was reached following the collation of several clinical trials conducted by the European Medicines Agency (EMA) which noted the effect in patients taking omega-3 fatty acid-containing medicines or supplements.
The report notes: “Unlike drugs, food supplements are freely available on the market and may also be taken over longer periods of time without medical supervision. Possible adverse health effects can therefore be more easily overlooked.”
“BfR recommends that particularly consumers with heart disease or corresponding risk factors should only take preparations containing omega-3 fatty acids, such as food supplements, in consultation with a doctor, especially over a longer period of time,” the author’s stress.
Since the publication, the Global Organisation for EPA & DHA Omega-3s (GOED) has pointed out that letters to healthcare professionals on the safety of omega-3 acid ethyl esters had since been posted by Italian Medicines Agency (AIFA), State Drug Control Service under the Ministry of Health Protection of the Republic of Lithuania, Spanish Agency of Medicines and Medical Devices and Agency for Medicinal Products and Medical Devices of Croatia.
They predicted that other EU member states where omega-3-acid ethyl esters are sold would soon be likely do the same.
Omega risks
It has been widely reported that long-chain omega-3 fatty acids intakes, mainly docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), results in an array of health benefits. These include the prevention of cardiovascular and vascular diseases, which has led to the recommendations around regular fish consumption or the use of omega-3 supplements.
The BfR had previously assessed the health risks associated with increased intakes of DHA and EPA in 2009, and highlighted the evidence suggesting increased cholesterol levels, impaired immune defence in the elderly, and increased mortality in those with heart disease. This led to their recommendations to set maximum levels of added DHA and EPA in foods, whilst not recommending additional supplements on top of regular fish consumption.
Implications
Dr Bill Harris, founder of OmegaQuant and adviser of the Food for the Brain charity, regarded the newly published warnings associated with high intakes.
“To me this seems reasonable, when restricted to n3 ethyl esters at 4 g per day. They say that ‘The aim is to inform physicians, pharmacists, and patients of the risk for atrial fibrillation’ in ‘products that contain omega-3 acid ethyl esters’. I would hope that they’d emphasize that the concern is focused on the high doses and in people at high risk for CVD – conditions that do not apply to the vast majority of individuals taking omega-3 supplements. It is also interesting that this is not considered an ‘adverse effect’ but a ‘side effect’.”
Following the new publication, GOED has presented an argument to the EMA to modify the decision to classify the increased risk of atrial fibrillation in those with heart disease or associated risk factors as “common”. The argument proposed that the evidence suggesting the risks had significant limitations and it was too early to conclude on the findings, and proposed this risk classification be changed to “not known”. However, the EMA declined to reconsider the ruling.
Regarding the impact of the publication, Harry Rice, GOED’s vice president of regulatory and scientific affairs, explains: “The BfR communication is based on the European Medicines Agency (EMA) communication regarding its concern about omega-3 ethyl ester medicines, so it should have no impact on the future labelling of food supplements across Europe.
“It's possible, however, that given the BfR's overreaching opinion, Germany may consider a warning on food supplements. What I suspect is the most likely scenario is that the BfR will request the European Commission to ask the European Food Safety Authority (EFSA) for an opinion on whether there is an increased risk of atrial fibrillation in individuals taking EPA/DHA supplements,” he adds.
Yet, he emphasises that a previous guidance publication by UK’s National Institute for Health and Care Excellence (NICE) in 2022 had accounted for these risks regarding intakes of omega-3 ethyl esters for reducing risk of cardiovascular events in those with raised triglycerides.
“I suspect other groups took this into account as well, so I don't imagine European intake recommendations for those with heart disease will change,” he asserts.
Further research is currently underway at GOED to assess the risk of atrial fibrillation associated with omega-3s, compared to the reported cardiovascular protective benefits. They note that this will be submitted for publication by the end of the year.