ADR that result in revision of patient information
|
| |
| Canada: Champix – Review completed and label updated with new information with respect to cardiovascular safety |
| |
Health Canada is informing Canadians that the review of Champix is now complete and the label has been updated with new information with respect to cardiovascular safety. Champix (the brand name for varenicline tartrate) is a prescription drug used to help patients quit smoking in combination with supportive counselling. Health Canada evaluated data from a quit-smoking clinical trial involving 700 smokers with cardiovascular disease (approximately 350 who received Champix and 350 who received a placebo or "sugar pills"). Cardiovascular disease is a broad term for any condition that affects the heart and/or blood vessels, including heart attack and stroke. The drug labelling for Champix has been updated to include a more detailed description of the study and findings, along with precautions for patients with respect to cardiovascular safety. Patients are advised to seek immediate medical attention if they think they might be experiencing a heart attack or stroke. It is important to note that smoking by itself is a major known risk factor for cardiovascular disease and that patients with cardiovascular disease can benefit greatly from quitting smoking. Patients with questions or concerns about Champix should talk to their health professional.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_07-eng.php
In Hong Kong, Champix (varenicline) Tab 0.5mg and 1mg are registered by Pfizer Corporation HK Ltd. and are prescription-only medicines. The news on the cardiovascular events has been released by Health Canada and other regulatory authorities previously and was posted on the website of Drug Office in June 2011 and July 2011. A letter to inform healthcare professionals has been issued on 17 June 2011. In view of Health Canada's action, the matter will be discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board.
Ends/ Friday, January 20, 2012
Issued at HKT 12:30
|
| |
|
