Drug major Pfizer has expanded its earlier recall of its Chantix (Varenicline) Tablets to include four additional lots, the U.D. Food and Drug Administration said.
Chantix, a treatment to help patients quit smoking, 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 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.
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.
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.
Pfizer has not received any reports of adverse events that have been related to this recall to date.
In similar recalls, Viona Pharmaceuticals Inc. in mid June recalled type 2 diabetes drug Metformin in the form of oral film-coated tablets for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine or NDMA, above ADI levels.+
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