The Medicines and Healthcare products Regulatory Agency (MHRA) has added atrial fibrillation (abnormally fast and irregular heartbeat) to the safety information of medicines containing omega-3-acid ethyl esters that are licensed for the treatment of hypertriglyceridaemia when changes to the diet alone have not worked. Hypertriglyceridaemia is a medical condition in which there is too much of a certain type of fat called triglycerides in the blood, which can increase the risk of coronary heart disease and cause inflammation of the pancreas (pancreatitis).
These medicines are available on prescription or as pharmacy medicines (behind the counter) in the UK and should not be confused with omega-3 dietary supplements. The majority of patients taking omega-3-acid ethyl ester medicines will not experience any adverse effects and can continue to attend routine medication reviews with their doctor or pharmacist.
Anyone taking these medicines for hypertriglyceridemia must seek medical attention if they develop symptoms of atrial fibrillation, such as palpitations, dizziness, shortness of breath and tiredness. Patients should not stop their hypertriglyceridaemia treatment without speaking with their doctor but should inform their healthcare professional of any current or past heart problems before using these medicines.
Healthcare professionals are advised to stop and discontinue treatment with these medicines should a patient develop atrial fibrillation. The decision to stop treatment should be informed by clinical judgement and assessment of the individual benefits and risks to the patient.
The MHRA regulatory decision comes after a European review identified a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors treated with omega-3-acid ethyl ester medicines compared to placebo, particularly highest at a daily dose of 4 grams. This review recommended that "atrial fibrillation" should be listed as 'common' in the product information since, from calculation of the data reviewed, the incidence would be 3.9% (it may affect up to 1 in 10 people) on a patient population with pre-existing cardiovascular disease or risk factors.
The findings of the European review were considered by the Pharmacovigilance Expert Advisory Committee (PEAG) of the Commission on Human Medicines (CHM), which agreed with the recommendations of European regulators to update the product information to include atrial fibrillation as a recognised side effect with a frequency of common.
Dr Alison Cave, MHRA Chief Safety Officer, said:
We keep the safety of all medicines, including omega-3-acid ethyl esters, under close review and act where necessary to protect patients.
Following a careful review of new safety data, atrial fibrillation is now listed as a common side effect for patients with established cardiovascular diseases or risk factors who are taking omega-3-acid ethyl ester medicines for hypertriglyceridemia.
It is important that patients inform their healthcare professional of any current or past heart problems before using these medicines. If you have been prescribed omega-3-acid ethyl esters, seek medical attention if you experience palpitations, dizziness, shortness of breath or tiredness, as these may be symptoms of atrial fibrillation. Do not stop taking your medicine without a discussion with your doctor.
If a patient develops atrial fibrillation whilst taking these medicines, treatment should be permanently discontinued. Please report any suspected side effects via our Yellow Card scheme website.
