The European Medicines Agency (EMA) has launched a review of data on the direct oral anti-coagulants (DOACs) Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban).
The decision follows the results of an observational study, commissioned by the EMA, which assessed the risk of major bleeding with DOACs when used to prevent thromboembolic events in patients with non-valvular atrial fibrillation, in comparison with other oral anti-coagulants.
Results from the study show differences in the risk of major bleeding between these medicines. The study also raises concerns about the level of adherence in clinical practice to restrictions, special warnings and precautions in the medicines’ product information.
The study followed a 2015 workshop that brought together experts and stakeholders to discuss the utility of pharmacokinetic and pharmacodynamic measurements in the clinical use of DOACs and whether these measurements could enhance the benefit-risk profile of these medicines.
The EMA review will consider whether the results of this study have implications for the use of DOACs in clinical practice and whether any changes to the conditions of use and current measures to minimise the risk of bleeding would be needed.