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Adverse effects
EMA reviews bleeding risk with direct oral anticoagulants

https://doi.org/10.1136/dtb.2019.000031

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    Review of: EU Pharmacoepidemiology and Pharmacovigilance Research Network. Characterising the risk of major bleeding in patients with non-valvular atrial fibrillation: non-interventional study of patients taking direct oral anticoagulants in the EU.

    Key learning points

    • The European Medicines Agency is reviewing the results of an observational study that analysed bleeding risks in patients taking direct oral anticoagulants (DOACs).

    • The study highlighted differences in the risk of major bleeding between DOACs.

    Results from a European Medicines Agency (EMA) study of direct oral anticoagulants (DOACs) highlighted differences in the risk of major bleeding between these medicines and raised concerns about adherence to restrictions, special warnings and precautions in the medicines’ product information.

    Overview

    The EMA has started a review of the results from an observational study characterising bleeding risk in patients with non-valvular atrial …

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    Footnotes

    • Contributors: DTB Team.

    • Provenance and peer review Commissioned; Internally peer reviewed.