Italian Medicines Agency Agenzia Italiana del Farmaco

Direct communication with healthcare professionals on Omega-3-acid ethyl ester medicines - Direct communication with healthcare professionals on Omega-3-acid ethyl ester medicines

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Direct communication with healthcare professionals on Omega-3-acid ethyl ester medicines

Omega-3-acid ethyl ester medicines: dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors.

Summary:
Systematic reviews and meta-analyses of randomized controlled trials 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. 

The observed risk of atrial fibrillation was found to be highest with a dose of 4 g/day. 
Healthcare professionals should advise patients to seek medical attention if they develop symptoms of atrial fibrillation.
If atrial fibrillation develops treatment with these medicines should be permanently discontinued.


Published on: 08 November 2023

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