Dear Health Care professional letter about the importance of careful use of medicinal products Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban)
05.09.2013
The marketing authorisation holders for medicinal products Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban) have, in collaboration with the European Meidines Agency (EMA) and Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to healthcare professionals with the aim to remind them about the careful use of these medicines.
Clinical trials and the post-marketing experience have demonstrated that the occurrence of major bleeding, including the events that led to death are not limited only to vitamin K antagonists and low-molecular weight heparins, but represent important risks associated with the use of these new anticoagulants. Furthermore, spontaneous reporting of adverse reactions to these medicines indicate that prescribers are not well informed about these medicines with regard to bleeding risk management.
Recommendations:
In the light of the aforementioned, prescribers should take into account risks from bleeding in individual patients and carefully follow the instructions on dosing, contraindications and warnings.
Here you may view the Dear Healthcare Professional Letter.
The Summary of Product Characteristics for Eliquis is available here.
The Summary of Product Characteristics for Pradaxa is available here and in the medicinal products database, available on the HALMED’s web pages in the Medicines section or here.
The Summary of Product Characteristics for Xarelto is available here.
HALMED has received two reports to bleeding (post-surgical bleeding and petechiae) associated with the use of these medicines. HALMED will continue to monitor the safe use of these medicines and will make any new safety information promptly publicly available.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
