ADR that result in revision of patient information
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| Canada: Health Canada decision on Trasylol (aprotinin) |
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Health Canada is advising Canadians of the outcome of its comprehensive safety review of the heart-surgery drug Trasylol (the brand name for aprotinin). After careful review, Health Canada has concluded that the benefits of Trasylol outweigh the risks when Trasylol is used as authorized by Health Canada. Trasylol is authorized for patients undergoing Coronary Artery Bypass Graft (CABG) surgery, also known as heart bypass surgery. The evidence does not suggest an increased risk of death in this use. As a result of this assessment, the manufacturer, Bayer Inc., can resume the marketing of Trasylol in Canada. However, new safety measures have been put in place to address new safety information identified during Health Canada's review. Health Canada has requested that strong warnings be added to the prescribing information emphasizing that there have been reports of an increased risk of death in some studies associated with Trasylol use outside of its authorized indication, and that Trasylol should only be used as authorized after careful consideration of the potential benefits and risks. Warnings have also been added emphasizing that physicians should adhere to the recommended procedures for the management of blood clotting, and that Trasylol increases the risk of kidney problems.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_124-eng.php
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Thursday, September 22, 2011
Issued at HKT 12:30
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