Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023

New safety information for Omega-3-acid ethyl esters

The PRAC agreed to add atrial fibrillation (irregular, rapid contraction of the heart) as a common side effect to the product information for medicines containing omega-3-acid ethyl esters. These medicines are indicated for the treatment of hypertriglyceridaemia, when a modification of diet and lifestyle alone are not sufficient to bring down levels of triglyceride, a type of fat, in the blood. Hypertriglyceridemia is a risk factor for coronary artery disease. Patients on these medications often have other conditions such as cardiovascular diseases and diabetes.

During a Periodic Safety Update Single Assessment (PSUSA) procedure, the PRAC considered systematic reviews and meta-analyses of randomised controlled clinical trials which highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors treated with omega-3-acid ethyl esters compared to placebo. The observed risk is highest with a dose of 4 g/daily. If atrial fibrillation develops, treatment should be permanently discontinued…