ADR that result in revision of patient information
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| Australia: Dabigatran (Pradaxa) and risk of bleeding |
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On 8 February 2013, the Therapeutic Goods Administration (TGA) published information for health professionals regarding dabigatran (Pradaxa) and the risk of bleeding. The TGA has updated that information below, including details of:
1. The TGA has completed two safety reviews of dabigatran - one completed in August 2012 and the other in April 2013. Both reviews reinforced the importance of appropriate patient selection for the safe use of dabigatran. In particular, when making a decision to prescribe dabigatran, a careful assessment of the risk factors for bleeding needs to be undertaken.
2. The concomitant use of dronedarone and dabigatran has been added as a contraindication.
3. Health professionals are reminded that dabigatran capsules should be stored and dispensed in the original packaging (blister pack or bottle). Repackaging dabigatran capsules increases the risk of exposure to moisture or humidity, potentially causing the medicine to breakdown and lose potency.
4. Health professionals are advised that dabigatran may have an effect on the results of some pathology tests.
5. Up to 8 February 2013, a total of 1054 cases of adverse events were reported to the TGA. Such cases included serious bleeding adverse events of the gastrointestinal and intracranial areas.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-dabigatran-111005.htm
In Hong Kong, there are three registered pharmaceutical products containing dabigatran, namely Pradaxa Cap 75mg (HK-57316), 110mg (HK-57315) and 150mg (HK-60516), and they are prescription-only medicines. Safety alerts on Pradaxa have been released by various overseas regulatory authorities and were posted on the DO website. Letters to inform healthcare professionals were issued on 19 August 2011 and 4 November 2011. The matters were discussed by the Registration Committee of the Pharmacy and Poisons Board in April 2012, December 2012 and April 2013, and the package inserts of the products have been subsequently updated to include the latest safety information. The DO will remain vigilant on any new safety update of the products.
Ends/ Friday, May 24, 2013
Issued at HKT 18:30
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