The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2013 (PDF).
This issue contains drug safety advice informing clinicians of updated contraindications and warnings for the newer oral anticoagulants apixaban (Eliquis®), dabigatran (Pradaxa®) and rivaroxaban (Xarelto®). A common set of contraindications have been applied for all three of these agents to include range of clinical conditions where the patient is at significant risk of major bleeding, as well as in combination with other anticoagulant agents. The full contraindications are as follows:
- A lesion or condition, if considered a significant risk factor for major bleeding. This may include:
- Current or recent gastrointestinal ulceration
- Presence 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 abnormalities
- Concomitant treatment with any other anticoagulant agent for example: 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
Clinicians are also reminded to be aware of the contraindications, posology, and warnings and precautions for use specific to each medicine as well as the patient's individual risk factors for bleeding including their renal function (dose adjustment may be required).
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.