Other safety alerts
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| Australia: New oral anticoagulants - apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto) - no evidence to support routine blood monitoring at this time |
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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.
The TGA has previously published information for health professionals regarding the use of apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto). As outlined in the previous statement, healthcare professionals are advised that 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 (link is external) 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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/new-oral-anticoagulants-apixaban-eliquis-dabigatran-pradaxa-and-rivaroxaban-xarelto
In Hong Kong, there are two registered pharmaceutical products containing apixaban, namely Eliquis Tab 2.5mg (HK-61377) and 5mg (HK-62094), three registered pharmaceutical products containing dabigatran, namely Pradaxa Cap 75mg (HK-57316), 110mg (HK-57315) and 150mg (HK-60516); and three registered pharmaceutical products containing rivaroxaban, namely Xarelto Tab 10mg (HK-57861), 15mg (HK-61396) and 20mg (HK-61395). All products are prescription-only medicines. A series of news regarding the bleeding risks associated with NOACs was posed on the website since 2011. The DH will remain vigilant on any safety updates of the products by other overseas regulatory authorities.
Ends/ Thursday, June 04, 2015
Issued at HKT 14:00
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