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Canada: Health Canada reviewing stop-smoking drug Champix (varenicline tartrate) and potential risk of heart problems in patients with heart disease (English Only)
 
Health Canada is informing Canadians of an ongoing review of the smoking-cessation aid Champix (the brand name for the prescription drug varenicline tartrate) and the possibility of a slightly increased risk of heart-related side effects in patients who have cardiovascular disease. The U.S. Food and Drug Administration recently communicated its findings from a review of new data from a clinical trial involving 700 smokers with cardiovascular disease. Cardiovascular disease is a broad term covering any disease that affects the heart and/or blood vessels. The risk for patients with cardiovascular disease taking Champix was found to be 2%, compared to 1% for those taking no drug. Health Canada is evaluating this and all other available information. We will take appropriate action as necessary based on the results of our review. Canadians will be updated with any new safety recommendations regarding Champix use.

Please refer to the following website in Health Canada for details: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_84-eng.php

In Hong Kong, varenicline is registered as Champix Tab 0.5mg and 1mg by Pfizer Corporation HK Ltd. and are prescription medicines. The news has been released by the US FDA and posted on the website of Pharmaceutical Service on 17 June 2011. A letter to inform healthcare professionals has been issued on the same day. Department of Health will keep vigilance against any new safety information related to the drug.



Ends/ Tuesday, June 28, 2011
Issued at HKT 12:30
 
Related Information:
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加拿大:Champix的审核已完成,并更新标签上有关心血管安全的资讯 上载于 2012-01-20
The United States: Chantix (varenicline) - updated study data (English Only) 上载于 2011-10-25
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European Union: European Medicines Agency confirms positive benefit-risk balance... 上载于 2011-07-22
澳门: 戒烟药Champix ® (戒必适®)安全性 上载于 2011-07-08
The United States: FDA Drug Safety Communication: Chantix (varenicline) may incr... 上载于 2011-06-17
 
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