Safety advice on particular drugs or classes of drugs
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| Singapore: Labelling updates to mitigate the risk of bleeding with new oral anticoagulants |
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Healthcare professionals have been informed by the HSA on the recent updates made to the labelling of new oral anticoagulants (NOACs), namely dabigatran, apixaban and rivaroxaban, related to the known risk of bleeding. The labelling updates include contraindication of all NOACs in patients with a lesion or condition if considered to be a significant risk of major bleeding, as well as those receiving concomitant treatment with any other anticoagulant. In addition to these shared contraindications, there are also other contraindications specific to each NOAC described in the package insert for each individual drug product. In view of the risk of haemorrhage associated with all anticoagulants, healthcare professionals are advised to take note of the indications, contraindications, posology/dosage, and warnings/precautions specific to each NOAC, as well as each individual patient's risk factors for bleeding, particularly age, weight and renal function when prescribing NOACs.
Please refer to the following website of HSA for details:http://www.hsa.gov.sg/publish/hsaportal/../labelling_updates.html
In Hong Kong, there are 2 registered pharmaceutical products containing apixaban, namely Eliquis Tab 2.5mg (HK-61377) and 5mg (HK-62094); 3 registered pharmaceutical products containing dabigatran, namely Pradaxa Cap 75mg (HK-57316), 110mg (HK-57315) and 150mg (HK-60516); and 3 registered pharmaceutical products containing rivaroxaban, namely Xarelto Tab 10mg (HK-57861), 15mg (HK-61396) and 20mg (HK-61395). All of the products are prescription-only medicines.
Related news on the bleeding with these new oral anticoagulants has been posted on the website of Drug Office subsequent to the announcement by TGA and MHRA on 25 September 2013 and 5 October 2013 respectively. A letter to inform healthcare professionals on the issue has been issued subsequent to TGA’s announcement. Department of Health will remain vigilant on new safety information related to these drugs issued by other health regulatory authorities.
Ends/ Saturday, April 26, 2014
Issued at HKT 12:30
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