TGA rejects monitoring for new oral anticoagulants


6 Jun 2015

There is no evidence to support the need for routine blood monitoring in patients being treated with new oral anticoagulants, the TGA has said.

The regulatory body undertook a review following reports that the safety of apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto) could be improved if routine blood monitoring was undertaken.

However as manufacturers had not undertaken dedicated studies to examine the issue “monitoring was not likely to significantly add to the use of clinical parameters to determine bleeding risk,” the review committee  determined.

Plasma monitoring may be useful in some clinical circumstances, such as overdose or emergency surgery, it said.


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