Pharmaceutical giant Pfizer has expanded a voluntary recall on its anti-smoking drug Chantix due to the presence of a potential cancer-causing agent.

The announcement was made by Pfizer on Thursday, saying that all lots of the drug's 0.5 and 1 milligram tablets will be affected by the said recall.

Reports said the affected products were distributed to wholesalers and distributors in the United States, U.S. Virgin Islands, and Puerto Rico between May 2019 and September this year.

The 0.5 mg Chantix bottles containing 56 tablets and have an expiration date from January 2022 to May 2023 will be recalled. Pfizer said the recall also affected the 1 mg Chantix bottles, also with 56 tablets, that have an expiration date from September 2021 to December 2023.

Chantix carton containing a blister pack of 11 0.5 mg tablets and a blister pack containing 42 1 mg tablets are also included in the recall. The expiration dates indicated on each carton were from August 2021 to January 2023.

Pfizer urged the wholesalers and distributors with an existing inventory of the said anti-smoking drug to stop using, selling and distributing it. The company also urged patients who use Chantix to contact their healthcare providers for other alternative treatment options.

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Nitrosamine in Pfizer's Anti-Smoking Drug Chantix

Pfizer said the voluntary recall of all lots of Chantix is due to the presence of a nitrosamine, called N-nitroso-varenicline, which has been found to be at or above the Food and Drug Administration's (FDA) interim acceptable intake limit. 

Pfizer noted that everyone is exposed to some level of nitrosamines since the chemical is common in water and foods, including cured and grilled meats, vegetables, and dairy products.  

However, the company said that "long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans."

Chantix is used as a treatment to help patients quit smoking and is only intended for short-term use. Despite containing the said cancer-causing agent, Pfizer said there is no immediate risk to patients taking the said medication. 

The company assured that the health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in Chantix.

Pfizer Recalls Anti-Smoking Drug Chantix

It was not the first time the pharmaceutical giant made a move to recall the anti-smoking drug nationwide. For the same reason it had nitrosamine above the established acceptable daily intake level, Pfizer also recalled 12 lots of Chantix in July.

The said recall involved two lots of Chantix 0.5 mg tablets, two lots of 1 mg tablets, and eight lots of a Chantix kit of 0.5 mg and 1 mg tablets.

The FDA approved Chantix in May 2006 as a prescription medication to help adults aged 18 and above quit smoking. It is typically used for 12 to 24 weeks.

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Written by: Joshua Summers

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