Apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto): Information for health professionals

Safety advisory - risk factors for bleeding

24 September 2013

Apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto) are oral anticoagulants approved by the TGA and all are now funded by the Pharmaceutical Benefits Scheme (PBS).

As use of these medicines is likely to increase following the recent changes to their PBS listing, it is timely to remind health professionals of the need to carefully consider each patient's risk factors for bleeding and observe the dosage recommendations, contraindications and precautions for use outlined in the respective Product Information (PI) when prescribing these oral anticoagulants.

Clinical trials and post-marketing experience have shown that major bleeding events, including those leading to death, have occurred with all of these products and with other anticoagulants. At this time, there is no specific antidote available for these medicines, and there are no current recommendations for the routine monitoring of anticoagulant activity once they are administered.

Prescribers should consider the following when prescribing these oral anticoagulants:

  • Patients should have renal function measured before commencing therapy. Refer to the relevant PI as dosage and recommendations for ongoing monitoring of renal function differ between the three medicines.
  • All should be used with caution in patients with an increased bleeding risk. Refer to the relevant PI, as contraindications and precautions differ between the three medicines. This may include patients with:
    • congenital or acquired coagulation disorders
    • thrombocytopenia or functional platelet defects
    • severe and end-stage renal disease
    • severe liver disease
    • active ulcerative gastrointestinal disease
    • recent gastrointestinal bleeding
    • recent biopsy or major trauma
    • recent intracranial haemorrhage
    • brain, spinal or ophthalmic surgery
    • vascular lesions at risk of bleeding (for example oesophageal varices, vascular aneurysms, arteriovenous malformations)
    • concomitant use of warfarin and low molecular weight heparin.
  • A patient's bleeding risk increases with age. Refer to the relevant PI for recommendations on dose adjustment according to renal function, age and weight.
  • Bleeding risk is increased with concomitant use of aspirin, clopidogrel and non-steroidal anti-inflammatory drugs. Each of these oral anticoagulants has additional drug-drug interactions that need to be taken into account.
  • During regular patient follow up, check for evidence of bleeding and monitor renal function.
  • Patients should be informed of the signs and symptoms of bleeding and the need to seek medical attention immediately if bleeding is suspected.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to our monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.