These meta-analyses of clinical trials versus placebo were performed on more than 80,000 patients.
toRisk of atrial (or atrial) fibrillation associated with omega-3 acid ethyl esters (be seen. case) in patients with cardiovascular disease or cardiovascular risk factors was the subject of a European evaluation, and the Pharmacovigilance Committee (PRAC) of the European Medicines Agency (EMA) published its conclusions in October 2023 (See. Our article is dated October 12, 2023).
A month later, in agreement with the National Agency for the Safety of Medicines and Health Products (ANSM), the laboratories concerned sent a letter to health professionals to make them aware of this change in the safety profile of ethyl esters. Acids, and defining new precautions that must be respected [1, 2].
Therapeutic indications :
A set of supporting data
An increased risk of atrial fibrillation (AF) with omega-3 ethyl esters has been demonstrated in meta-analyses of controlled clinical trials. Reverse The placebo was administered to more than 80,000 patients, most of whom had cardiovascular disease or cardiovascular risk factors.
In addition to showing an increased risk of atrial fibrillation Reverse Placebo These analyzes showed that this risk increased with the dose of omega-3 acid ethyl esters; This risk is highest at a dose of 4 g/day, which corresponds to the maximum daily dose stated in the Marketing Authorization (AMM) for OMACOR (4 capsules).
In their letter, the laboratories cite three meta-analyses in particular:
- A meta-analysis showed that omega-3 fatty acid supplements were associated with an increased risk of atrial fibrillation compared with placebo (IRR 1.37, 95% CI). [1,22-1,54]p < 0.001)  ;
- A systematic review and meta-analysis showed that omega-3 fatty acid supplementation was associated with a dose-dependent increased risk of atrial fibrillation (HR 1.25, 95% CI [1,07-1,46], p = 0.013). The hazard ratio (HR) was highest in trials testing doses >1 g/day of omega-3 fatty acids (HR 1.49, 95% CI [1,04-2,15]p = 0.042) compared to test doses ≥ 1 g/day (HR 1.12, 95% CI [1,03-1,22]p = 0.024, p for interaction < 0.001)  ;
- A meta-analysis evaluating the clinical value of omega-3 fatty acid supplements found that omega-3 fatty acid supplements were associated with an increased risk of atrial fibrillation (RR 1.32, 95% CI). [1,11-1,58]p = 0.002) .
Identify warning signs and stop treatment
Based on these new safety data, it is recommended that:
- To physicians: permanently discontinue treatment if atrial fibrillation occurs;
- Healthcare professionals in contact with the patient: To identify symptoms of atrial (or atrial) fibrillation such as feeling dizzy, weak, heart palpitations, or shortness of breath;
- For patients: Consult a doctor if there are signs indicating atrial fibrillation.
The Summary of Product Characteristics (SmPC) and the OMACOR Publication leaflet should be updated to incorporate this new information.