Based on the data collected, atrial fibrillation is considered a potential side effect of omega-3 ethyl esters, a drug prescribed for high triglyceride levels.
- The EMA and ANSM warn of an increased risk of atrial fibrillation in patients with cardiovascular diseases or cardiovascular risk factors taking ethyl esters of omega-3 acids.
- The observed risk of atrial fibrillation is higher with a dose of 4g/day.
- Patients should seek medical attention if they develop symptoms of atrial fibrillation.
After analyzing the periodic pharmacovigilance reports, the pharmacovigilance committee (PRAC) of the European Medicines Agency (EMA) concluded that omega-3 ethyl esters, an omega-3-based treatment, could increase the risk of suffering from atrial fibrillation.
A letter from the laboratories, transmitted under the authority of the National Medicines Safety Agency (ANSM), was sent to healthcare professionals to alert them of changes in the warnings and precautions to be taken with this treatment.
Atrial fibrillation : an adverse effect of omega-3 ethyl esters
THE mail, sent last November, specifies that the evaluation of omega-3 ethyl esters was based on “data from several systematic reviews of the literature and meta-analyses of several large randomized controlled clinical trials, including a total of more than 80,000 patients, mainly suffering from cardiovascular diseases or presenting factors of risks cardiovascular”.
The results showed “increased risk and dose-dependent occurrence of atrial fibrillation (or atrial) (FA) in patients suffering from cardiovascular diseases or presenting cardiovascular risk factors and treated with specialties based on ethyl esters of omega-3 acids, compared to those treated with a placebo”.
The risk of developing this heart rhythm disorder is higher with a dose of 4g/day of omega-3 medication.
Thus, the European and French health authorities have recommended that the instructions and the Summary of Product Characteristics (CPR) of this treatment be updated to indicate the increased risk of atrial fibrillation. “The EMA also recommended including atrial fibrillation (or atrial) among the common side effects”explains the document.
Atrial fibrillation and ethyl esters of omega-3 acids: consult in case of symptoms
The evil’ANSM and the laboratories provided further recommendations. They state that healthcare professionals should advise patients taking omega-3 ethyl esters to seek medical attention if they develop symptoms of atrial fibrillation such as feeling dizzy, asthenia, palpitations or shortness of breath.
This disease is characterized by anarchic and rapid electrical activity of the muscle of the atria of the heart which leads it to have a disordered and ineffective contraction. It is followed by irregular and rapid contractions in the ventricles. Nearly 3 in 10 strokes are secondary to atrial fibrillation.
In addition, institutions also ask doctors to stop their patient’s treatment if they have atrial fibrillation.
