Drug company Pfizer has expanded its earlier recall of Chantix – Varenicline – tablets to include four additional lots, the United States Food and Drug Administration said, reported RTTNews. Chantix is a treatment to help people quit smoking.
It has been recalled due to the presence of a nitrosamine impurity, N-nitroso-varenicline, above the established Acceptable Daily Intake or ADI level.
The recall expansion includes an additional four lots of Chantix 0.5mg/1 mg tablets to the patient level. The initial recall in July involved 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 to the patient level. With the new recall, the number of lots recalled has risen to 16.
According to the RTTNews story published on 17 August 2021, all affected products lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from June 2019 to June 2021.
According to the agency, long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans. However, there is no immediate risk to patients taking Chantix, which is intended for short term use.
The FDA stated that the health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.
Everyone is exposed to some level of nitrosamines, which are common in water and foods, including cured and grilled meats, dairy products and vegetables. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time, RTTNews continues.
Pfizer said it believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix are asked to consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options.
RTTNews story on Nasdaq – Pfizer Expands Recall Of Anti-smoking Drug Chantix (Open access)
See also from the MedicalBrief archive
Smoking-cessation medication not beneficial in the long-term
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Anti-smoking drug has had little impact
Varenicline helps smokers quit gradually