Other safety alerts
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| The United Kingdom: Omega-3-acid ethyl ester medicines (Omacor/Teromeg 1000mg capsules): dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that systematic reviews and meta-analyses of randomised controlled trials have 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 ester medicines compared to placebo.
A recent European regulatory review recommended “atrial fibrillation” should be listed as a common adverse reaction (may affect up to 1 in 10 people) in the product information of medicines containing omega-3-acid ethyl esters. The review of safety and efficacy data for omega-3-acid ethyl ester medicines licensed for the treatment of hypertriglyceridaemia considered a dose-dependent increased risk of atrial fibrillation which had been identified by several meta-analyses of large randomised controlled trials. These trials investigated the effect on cardiovascular outcomes compared with placebo enrolling more than 80,000 patients, mostly with cardiovascular diseases or cardiovascular risk factors. The frequency of atrial fibrillation was determined as “common” since, from this data, the incidence would be 3.9%.
The findings of this review were considered by the Pharmacovigilance Expert Advisory Committee (PEAG) of the Commission on Human Medicines, which agreed with the recommendations of European regulators to update the product information. A letter has been sent to United Kingdom healthcare professionals. The product information recommends permanent discontinuation of treatment for patients who develop atrial fibrillation whilst taking these medicines for hypertriglyceridaemia. Clinical judgment and assessment of the individual benefits and risks to the patient should be taken into consideration before any decision to stop treatment. The PEAG noted that, in the case of patients with a previous or current diagnosis of atrial fibrillation, the product information does not provide specific advice or contraindicate use of these medicines.
The MHRA does not regulate food or dietary supplements that are marketed without reference to a medicinal effect/claim. Neither the randomised controlled trials or the review evaluated dietary consumption of fish and other foods rich in omega-3 nor supplements, and the MHRA is unable to give advice on the risk in individuals who consume dietary omega-3 supplements without a known history of cardiovascular disease or significant cardiovascular risk factors.
Up to 13 Nov 2023, the MHRA has not received any Yellow Card reports describing atrial fibrillation in association with a medicinal product containing omega-3 acids as the active substance.
Advice for healthcare professionals:
- Atrial fibrillation is now listed as an adverse drug reaction with a “common” frequency (may affect up to 1 in 10 people) for medicines containing omega-3-acid ethyl esters licensed for the treatment of hypertriglyceridaemia.
- The observed risk was found to be highest with a dose of 4g/day.
- Advise patients taking omega-3-acid ethyl ester medicines for the treatment of hypertriglyceridaemia to seek medical attention if they develop symptoms of atrial fibrillation (include palpitations, dizziness, shortness of breath and tiredness).
- If a patient develops atrial fibrillation whilst taking these medicines for the treatment of hypertriglyceridaemia then the medicine should be discontinued permanently.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/omega-3-acid-ethyl-ester-medicines-omacor-slash-teromeg-1000mg-capsules-dose-dependent-increased-risk-of-atrial-fibrillation-in-patients-with-established-cardiovascular-diseases-or-cardiovascular-risk-factors
In Hong Kong, Omacor Capsules 1000mg (HK-66442) is a pharmaceutical product registered by Lee’s Pharmaceutical (HK) Limited. It is a prescription-only medicine. Teromeg 1000mg capsules is not a registered pharmaceutical product. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to omega-3-acid ethyl esters. Related news was previously issued by European Medicines Agency, and was posted on the Drug Office website on 3 Oct 2023. Letters to inform local healthcare professionals were issued by the DH on the same day. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Tuesday, Jan 23, 2024
Issued at HKT 16:00
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