New oral anticoagulants - apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto)

No evidence to support routine blood monitoring at this time

3 June 2015

Consumers and health professionals are advised that a recently completed TGA review has found that based on the current information there is no evidence to support a recommendation for routine blood monitoring to improve the safety of the new oral anticoagulants (NOACs).

The NOACs are apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto). They are oral medications, sometimes referred to as 'blood thinners', that are used to prevent or treat blood clots.

The TGA undertook the review following recent publication of articles in the medical literature which suggested that the safety of these medicines could be improved if routine blood monitoring was undertaken.

Following an earlier review of dabigatran, the TGA sought advice from the Advisory Committee on the Safety of Medicines (ACSOM) and then requested further information from each of the NOAC sponsors relating to blood monitoring during treatment with these medicines.

The TGA's finding included consideration of the ACSOM advice and information provided by the sponsors.

Information for consumers

There are no changes to the way these medicines are used.

If you or someone you care for takes apixaban (Eliquis), dabigatran (Pradaxa) or rivaroxaban (Xarelto), do not stop or change the way the medicines are taken without first consulting your health professional.

If you have any questions or concerns about the above information, speak to your health professional.

Information for health professionals

The TGA has previously published information for health professionals regarding the use of apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto).

As outlined in that statement, the risk factors for bleeding associated with the NOACs include renal impairment, age, concomitant use of certain other medicines and the presence of conditions/circumstances that generally increase bleeding risk.

Dose should be guided by clinical parameters, as detailed in the Product Information of the individual products.

The NOAC sponsors have not undertaken dedicated studies to evaluate the effects of routine plasma monitoring on the safety profile of their medicines, as such monitoring is not likely to significantly add to the use of clinical parameters to determine bleeding risk.

Therefore, the TGA's review has found there is no evidence at this time to support a recommendation for routine plasma monitoring in patients being treated with these medicines.

However, plasma monitoring may be useful in some clinical circumstances, such as overdose or emergency surgery.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's 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.