Direct oral anticoagulants (apixaban, dabigatran etexilate, rivaroxaban): no application changes required
2020.03.30
Active substance: apixaban | dabigatran etexilate | rivaroxaban
30.03.2020 - CHMP opinion
Following a review of the results of a European study with real-world drug-related data from use, no change in the use criteria of the direct oral anticoagulants Eliquis® (apixaban), Pradaxa® (dabigatran etexilate), and Xarelto® (rivaroxaban) is required.
08.02.2019 - Procedure started
EMA is reviewing the results of a study with the direct oral anticoagulants Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban). This observational study, commissioned by EMA, assessed the risk of major bleedings with these medicines when used to prevent blood clotting in patients with non-valvular atrial fibrillation (irregular rapid contractions of the heart), in comparison with other oral anticoagulants.
Results from this study show differences in the risk of major bleedings between these medicines. The study also found evidence of non-adherence in clinical practice to restrictions, special warnings and precautions included in the product information of these medicines.
The review aims to assess whether the results of this study have implications on the use of the medicines in clinical practice and whether any changes to the conditions of use and current measures to minimise risks would be needed.
The study followed a workshop held by EMA in 2015, which highlighted the need for further research to optimise use of anticoagulants in clinical practice. The results of this study have not yet been published.
More about the medicines:
The direct oral anticoagulants Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban) are taken by mouth to prevent blood clotting in a number of situations, including for the prevention of venous thromboembolism (the formation of blood clots in the veins) in patients who have had an operation to replace a hip or knee, and prevention of stroke (caused by blood clots in the brain) and the formation of clots in other organs in patients with non-valvular atrial fibrillation. They are also used to treat deep vein thrombosis (a blood clot in a deep vein, usually in the leg) and pulmonary embolism (a clot in a blood vessel supplying the lungs), and to prevent these conditions from reoccurring.
These medicines work by blocking a single blood clotting factor in the body; this is why they are called ‘direct anticoagulants’ as opposed to other anticoagulants such as warfarin that target various clotting factors.
More about the procedure:
The review of direct oral anticoagulants has been initiated at the request of the EMA Executive Director, under Article 5(3) of Regulation 726/2004.
The review is being carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will issue a scientific opinion.
Further information
More information about these medicines can be found on the EMA website: