Medicine recalls
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| Canada: CHAMPIX (varenicline): Potential risk posed by long-term exposure to nitrosamine impurity, N-nitrosovarenicline, exceeding acceptable intake limit |
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Health Canada announces that testing results received from Pfizer Canada ULC identified 5 lots of CHAMPIX with levels of a nitrosamine impurity, N-nitrosovarenicline, above the acceptable intake limit established by Health Canada. As a result, Health Canada requested that Pfizer Canada ULC recall the 5 impacted lots. The affected products are
- CHAMPIX 0.5 mg and 1 mg Tablet, Kit (lot number: 00019062, 00020452, 00020451)
- CHAMPIX 0.5 mg Tablet (lot number: ED7397)
- CHAMPIX 1 mg Tablet (lot number: 00020013)
N-nitrosovarenicline, a nitrosamine impurity, has been shown to cause gene mutations in an in vitro study, indicating that its presence in CHAMPIX may be associated with a potential increased cancer risk in humans. However, studies have not been conducted to determine whether exposure to N-nitrosovarenicline leads to the development of cancer in animals or humans. Some nitrosamine impurities are probable human carcinogens. This means that long-term exposure to a level above what is considered safe could increase the risk of cancer. Health Canada established an acceptable intake limit based on available scientific data. There is no immediate risk to patients taking this medication as an increased cancer risk would be associated with long-term use.
Health Canada continues to assess information on this issue and is monitoring this situation closely.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../75961a-eng.php
In Hong Kong, Champix Tab 0.5mg (HK-55479), Champix Tab 0.5mg & 1mg (HK-55462) and Champix Tab 1mg (HK-55437) are pharmaceutical products registered by Pfizer Corporation Hong Kong Limited (Pfizer), and are prescription-only medicines. As confirmed with Pfizer, the affected lots have not been imported into Hong Kong. Related news was previously issued by Health Canada, and was posted on the Drug Office website on 16 Jun 2021.
Ends/Friday, Jul 2, 2021
Issued at HKT 16:00
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