Dear Health Care Professional letter about the new contraindication of the medicinal product Pradaxa (dabigatran etexilate) in patients with a prosthetic heart valve that need anticoagulant treatment
The company Boehringer Ingelheim Zagreb d.o.o., the marketing authorisation holder for the medicinal product Pradaxa, has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care providers notifying them about the new contraindication in patients with a prosthetic heart valve that need anticoagulant treatment. The contraindication is introduced due to an increased risk of thromboembolia and bleeding as compared to warfarin.
You may view the text of the letter here (in Croatian).
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.