All batches of Chantix, a popular drug to curb smoking habits, have been voluntarily recalled by pharmaceutical giants Pfizer due to the presence of an amount of carcinogenic nitrosamine above the US Food and Drug Administration’s acceptable limit, the company announced on Thursday.
The announcement to recall Chantix 0.5 mg and 1 mg tablets comes after Pfizer had early to issued a similar recall of several lots of the popular anti-smoking medication because it might have too much of the carcinogen N-nitroso-varenicline that reaches or exceeds the FDA’s acceptable intake limit.
However, in a statement, Pfizer said the company’s latest expanded recall is meant as a precautionary measure.
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Furthermore, in the issued statement posted on FDA’s website, Pfizer said, “Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”
Meanwhile, FDA stated that nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables.
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“Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” their statement read.
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However, they added that there is no immediate risk to patients who are taking Chantix. But they ought to let their health care provider know so as to see if alternative treatments are available.
Approved by the FDA in 2006, Chantix is pitched to help people quit the smoking habit but it’s intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke, according to the Centers for Disease Control and Prevention.