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December 21, 2023 at 1:45 pm #2818
Anonymous
InactiveNew oral anticoagulants apixaban (Eliquis?), dabigatran (Pradaxa) and rivaroxaban (Xarelto?): risk of serious haemorrhage—clarified contraindications apply to all three medicines
Article date: October 2013
Summary
We previously advised that the contraindications for dabigatran had been clarified to include a range of clinical conditions where the patient is at significant risk of major bleeding, as well as in combination with other anticoagulant agents
Because similar risks are associated with the other new oral anticoagulants (apixaban and rivaroxaban), these contraindications have been applied across all three new oral anticoagulants for all indications and dosesDabigatran (Pradaxa) is a potent, orally active, direct inhibitor of free thrombin, fibrin-bound thrombin and thrombin-induced platelet aggregation.
Apixaban (Eliquis ?) and rivaroxaban (Xarelto ?) are direct, highly selective, orally active inhibitors of activated factor X (factor Xa).
All three new oral anticoagulants are licensed for:
prevention of venous thromboembolic events in adults who have had elective total hip-replacement or knee-replacement surgery
prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation and one or more cardiovascular risk factors
Rivaroxaban is additionally licensed for:treatment of deep-vein thrombosis and pulmonary embolism, and prevention of their recurrence, in adults
Risk of haemorrhage
Haemorrhage is a common adverse effect of all anticoagulants. Although these three new oral anticoagulants have some differing contraindications due to their different properties, the contraindications in patients with conditions putting them at significant risk of major bleeding, and those relating to use with other concomitant anticoagulants, now apply to all three of the medicines. This is the result of a European review.
Updated advice on contraindications and warnings:
The following contraindications now apply to all three new oral anticoagulants, for all doses and indications:
A lesion or condition, if considered a significant risk factor for major bleeding. This may include:
current or recent gastrointestinal ulcerationpresence of malignant neoplasm at high risk of bleeding
recent brain or spinal injury
recent brain, spinal, or ophthalmic surgery
recent intracranial haemorrhage
known or suspected oesophageal varices
arteriovenous malformation
vascular aneurysms, or major intraspinal or intracerebral vascular abnormalitiesConcomitant treatment with any other anticoagulant agent—eg, unfractionated heparin, low molecular weight heparin (such as enoxaparin or dalteparin), heparin derivatives (such as fondaparinux), or oral anticoagulants (such as warfarin).
Exceptions are switching of therapy to or from the medicine, or when unfractionated heparin is given at doses necessary to maintain an open central venous or arterial catheter.
MEDICINES HEALTH REGULATORY AGENCY -UK.
G Mohan.
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