ADRs that result in revision of product information or suspension of marketing authorisation
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| Canada: Multaq (dronedarone) - information on increase in heart-related events in patients with permanent atrial fibrillation |
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This is the update to the announcement made by Health Canada on 22 July 2011 regarding the review of Multaq (dronedarone) and the potential for an increased risk of cardiovascular events. Sanofi-aventis Canada Inc. in collaboration with Health Canada would like to inform you of important new safety information regarding Multaq which will be reflected on the Product Monograph. The information is based on preliminary data arising from the recently discontinued PALLAS trial such as: Multaq must not be prescribed in patients with permanent AF (duration for at least 6 months or duration unknown) and in whom an attempt to restore sinus rhythm is no longer considered, Multaq treatment should be stopped in patients with permanent AF, and it is recommended to closely monitor patients taking Multaq. If patients treated with Multaq develop permanent AF, treatment with Multaq should be discontinued.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/multaq_2_hpc-cps-eng.php
In Hong Kong, Multaq (dronedarone) is registered by Sanofi-Aventis HK Ltd., and is a prescription-only medicine. The risk of cardiovascular events has been released by the EMA on 12 July 2011 and a letter to inform healthcare professionals was issued on the same day. Updates on Multaq (dronedarone) has been released by the EMA, the FDA and Health Canada and was posted on the website of Pharmaceutical Service on 22 July 2011. Another letter to inform healthcare professionals was issued on the same day. According to Sanofi-Aventis HK Ltd., the package insert will be updated to include the above updated safety information.
Ends/ Friday, August 5, 2011
Issued at HKT 15:00
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