Pfizer, the influential pharmaceutical corporation, is recalling 12 batches of Chantix, a popular anti-smoking medication, after detecting excessive levels of a chemical linked to cancer.
The Food and Drug Administration (FDA) on July 19 released a statement to inform that Pfizer has widened the voluntary recall of Chantix, or varenicline, to include 12 additional lots from consumers over concerns with the presence of nitrosamine in their products.
According to Pfizer, their Chantix drugs contained N-nitroso-varenicline, a type of organic substance known as nitrosamine, at levels that exceeded its acceptable intake limit.
Although the amount in Pfizer’s Chantix will not result in immediate damage, excessive intake of this compound, as the pharmaceutical giant noted, can be linked to a potentially higher risk of cancer.
Nitrosamine is popularly found in meats, dairy products, and cosmetics, including cured and grilled meats, cheeses, and vegetables. Consistent consumption of this chemical can also lead to vulnerability to cancer, Pfizer said in a statement.
The recalled patches include two 0.5 mg tablet lots, two 1.0 mg lots, and eight lots of a Chantix kit that includes both 0.5 mg and 1.0 mg doses. From June 2019 through June 2021, the recalled products had been distributed to wholesalers and distributors in the United States and Puerto Rico.
When global drug regulators required pharmaceutical companies to conduct a probe for scanning impurities that can occur in certain medicines, Pfizer launched internal testing and discovered the unexpected presence of nitrosamines in their Chantix merchandise, reported FiercePharma.
According to the FDA, this finding prompted a halt in the global distribution of Chantix in late June this year and the recall of some lots of their anti-smoking pill in the U.S. at the beginning of July.
FiercePharma added that while Chantix brought about $919 million to the company last year, the drug has no longer had U.S. patent protections since November.
Still, Pfizer and the FDA believed that the anti-smoking medication offers benefits in terms of helping a person with their smoking problems.
“The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline,” the company said, given that nitrosamine is so common that “everyone is exposed to some level of it.”
About the patients who are currently taking Chantix, the FDA does not initiate a complete abandonment of the pills but rather recommends recipients to seek doctor advice for using the drug or switch to alternatives.
Pfizer said so far, it has not received any reports of adverse events relatable to the recall.