November 2015

Safety Related Changes

Pradaxa (dabigatran etexilate) is now also indicated in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults.

Pradaxa (dabigatran etexilate) is now also contraindicated with a lesion or condition at risk of major bleeding (including current, recent GI ulcer; malignant neoplasm with high bleeding risk; recent brain/ spinal injury, brain/ spinal/ ophthalmic surgery, intracranial haemorrhage; oesophageal varices including suspected; arteriovenous malformation; vascular aneurysm; major intraspinal, intracerebral vascular abnormality) and also with concomitant anticoagulants, e.g. unfractionated heparin (excluding when given to maintain open central venous, arterial catheter), LMWH (e.g. enoxaparin, dalteparin), heparin derivatives (e.g. fondaparinux), or oral anticoagulants (e.g. warfarin, rivaroxaban, apixaban) excluding when switching anticoagulant therapy.

This list is a summary of only some of the changes that have occurred over the last month. Before prescribing, always refer to the full product information.

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