Drug major Pfizer has again expanded the earlier two recalls of its anti-smoking Drug Chantix (Varenicline) in the form of tablets, to now include all the lots, for the potential presence of nitrosamine impurity, N-Nitroso-varenicline, at or above the FDA interim acceptable intake limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement.
In July, Pfizer had initially recalled two lots of Chantix 0.5mg tablets, two lots of Chantix 1 mg tablets, and eight lots of a Chantix kit of 0.5mg/1 mg tablets for the similar nitrosamine impurity issue. Later in August, it expanded the recall to include additional four lots of Chantix kit 0.5mg/1 mg tablets.
The current recall involves all (156) lots of Chantix 0.5 mg and 1 mg tablets. Pfizer said it is undertaking this precautionary measure as alternative suppliers have been approved in the U.S.
The agency noted that though there is no immediate risk to patients taking this medication, but long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans.
The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline, it added.
The company is yet to receive any reports of adverse events assessed to be related to this recall.
Chantix is indicated to help patients quit smoking and is intended for short term use. The drug has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program.
The affected products are packed in bottles of 56 tablets and cartons containing 4 blister packs of 14 tablets each as well as cartons containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets.
T*hey were distributed to wholesalers and distributors across the U.S., US Virgin Islands and Puerto Rico from May 2019 to September 2021. The expiration dates range from August 2021 to December 2023.
The company has urged patients currently taking Chantix to consult with their healthcare provider about alternative treatment options. It has also asked wholesalers and distributors with an existing inventory of Chantix tablets to stop use and distribution and quarantine the product immediately.
Nitrosamine, a known environmental contaminant, is classified as a probable human carcinogen that could cause cancer. This is generally found in water and foods, including cured and grilled meats, dairy products, and vegetables.
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