Medicine recalls
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| Australia: Varenicline: TGA investigation: potential low levels of contamination with N-nitrosovarenicline |
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Therapeutic Goods Administration (TGA) is advising consumers and health professionals that it is investigating potential contamination of varenicline medicines with the nitrosamine impurity, N-nitrosovarenicline.
Varenicline, marketed in Australia as Champix, is a prescription medicine that assists adults to stop smoking by helping to reduce nicotine cravings and withdrawal symptoms. Smoking is associated with serious health problems that can lead to death.
The TGA has been advised that very low levels of the N-nitrosovarenicline have been detected in Australian varenicline products.
As a precautionary measure, the sponsor of Champix, Pfizer Australia, has paused global distribution of this product while this issue is investigated. In addition, two batches have been recalled from pharmacies that were identified as containing unacceptable levels of N-nitrosovarenicline. The affected product is CHAMPIX varenicline (as tartrate) 1.0mg tablet blister pack (batch number: EM9960 and EM9961). Details of this recall can be found in the TGA’s System for Australian Recall Actions database.
Consumers are advised to continue to take their varenicline medicines as prescribed. Patients should not stop taking their varenicline medicines unless instructed to by their health professional.
N-nitrosovarenicline is a type of nitrosamine that is present as an impurity. Nitrosamines are commonly found in low levels in a variety of foods, particularly smoked and cured meats, as well as in some drinking water and in air pollution. Long-term exposure, over many years, can increase an individual's risk of developing cancer.
The additional risk that would be posed by potential trace levels of N-nitrosovarenicline in varenicline medicines is considered to be very low. There are no data available to directly evaluate the carcinogenic potential of N-nitrosovarenicline.
The TGA is working with varenicline sponsors to further investigate this issue and determine what actions may be required. Sponsors of affected medicines are taking corrective action to introduce impurity control measures to ensure that only batches of varenicline that comply with internationally acceptable intake limits are released. The TGA and other international regulators will continue to monitor medicines to ensure that they meet appropriate quality standards.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/varenicline
In Hong Kong, Champix Tab 0.5mg (HK-55479), Champix Tab 0.5mg & 1mg (HK-55462) and Champix Tab 1mg (HK-55437) are registered pharmaceutical products containing varenicline. All products are 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 various overseas drug regulatory authorities, and was posted on the Drug Office website since 16 Jun 2021, with the latest update posted on 20 Jul 2021.
Ends/Friday, Aug 6, 2021
Issued at HKT 16:00
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