Direct Healthcare Professional Communication (DHPC) on omega-3 fatty acid-containing drugs: dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular disease or cardiovascular risk factors
2023.11.16
Active substance: omega-3 fatty acid
In agreement with the Federal Institute for Drugs and Medical Devices (BfArM), the marketing authorisation holders of omega-3 fatty acid-containing medicinal products inform that systematic reviews and meta-analyses of randomised controlled trials have shown a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular disease or cardiovascular risk factors treated with omega-3 fatty acid-containing medicinal products compared to placebo.
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