ADR that result in revision of patient information
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| Australia: Dabigatran (Pradaxa) and risk of bleeding |
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Dabigatran (Pradaxa) is an oral anticoagulant medicine used for the prevention of clots and emboli after major orthopaedic surgery and to prevent stroke and other systemic emboli in people with non-valvular atrial fibrillation (AF). As with any anticoagulants, including warfarin, there is a risk of bleeding when using this medicine. In August 2012, the TGA completed a safety review of dabigatran. The review reinforced the importance of appropriate patient selection for the safe use of dabigatran, in particular, assessment of the risk factors for bleeding. Up to 8 November 2012, a total of 935 cases of adverse events were reported to the TGA. Such cases included serious bleeding adverse events of the gastrointestinal and intracranial areas.
Prescribers are advised that dabigatran must not be used in patients with prosthetic heart valves. A clinical trial in Europe and Canada (RE-ALIGN) was recently discontinued as patients taking dabigatran were more likely to experience strokes, heart attacks and blood clots forming on the mechanical heart valves than patients taking warfarin. Prescribers are reminded that dabigatran is indicated for use in patients with non-valvular AF. Patients with prosthetic heart valves who are taking dabigatran should be transitioned to a different anticoagulant medication. Boehringer Ingelheim Pty Ltd is updating the Product Information to reflect this advice.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-dabigatran-111005.htm#factors
In Hong Kong, Pradaxa 75mg (HK-57316), 110mg (HK-57315) and 150mg (HK-60516) Capsules are registered by Boehringer Ingelheim (HK) Ltd. and are prescription-only medicines. Safety alerts on Pradaxa has been released by various overseas regulatory authorities and the matter was discussed in the meetings of the Registration Committee of the Pharmacy and Poisons Board in April and December 2012. Letters to inform healthcare professionals were issued on 19 August 2011 and 4 November 2011. As reported on 15 December 2012, the issue of the contraindicated use in patients with prosthetic heart valves will be further discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The Department of Health will keep vigilant on any updated news of this medicine.
Ends/ Saturday, February 09, 2013
Issued at HKT 12:00
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