其 他 安 全 警 示
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| Canada: Updated safety information for Multaq (dronedarone) related to liver injury(English Only) |
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Sanofi-aventis Canada Inc., and Health Canada inform patients of important safety information related to liver injury, reported in patients treated with Multaq. Multaq helps control abnormal heart rate and rhythm called atrial fibrillation and can lower the risk of having to go into the hospital for heart problems. Patients should discuss with their healthcare professionals this new safety information regarding Multaq treatment. Patients treated with Multaq should immediately report to their doctors symptoms possibly suggesting liver injury (such as: Loss of appetite, nausea, vomiting, unusual tiredness, right upper stomach area pain or discomfort, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, or itching) and patients should consider obtaining periodic liver function tests.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/multaq_pc-cp-eng.php
In Hong Kong, dronedarone (Multaq) is registered by Sanofi-Aventis HK Ltd., and is a prescription drug. The above safety news was released by other regulatory authorities previously, namely, US Food and Drug Administration, UK Medicines and Healthcare products Regulatory Agency and European Medicines Agency, and was posted on the website of Pharmaceutical Service on 15 January 2011 and 22 January 2011 respectively. Letter to inform healthcare professionals about the risk of severe liver injury was issued by the Department of Health on 15 January 2011 and the package insert is being updated to include the appropriate warnings.
Ends/ Wednesday, March 16, 2011
Issued at HKT 12:30
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