Cancer Concerns Lead to ‘Precautionary’ Recall of Anti-Smoking Drug


In this June 11, 2009 file photo, a customer at the Red Key Taven in Indianapolis lights a cigarette. (AP Photo / Darron Cummings, file)

(WTAJ) – Popular drug to curb smoking habits recalled due to consumer safety concerns.

Pfizer has announced a voluntary recall of all lots of Chantix 0.5 mg and 1 mg tablets due to the presence of nitrosamine in excess of the Food and Drug Administration’s acceptable limit.

The recall comes two months after Pfizer suspended distribution of the drug in July and pulled nine lots from production and shelves. Pfizer has advised wholesalers and distributors with existing inventory to immediately stop distribution and production.

Chantix was approved by the FDA in 2006 as a prescription drug used to help adults quit smoking. The drug is commonly used for 12 to 24 weeks.

There is no immediate risk to patients currently taking Chantix, according to a statement from the company posted on the FDA website. However, patients taking the drug should consult their healthcare provider to determine if alternative treatments are available.

The affected lots were sent to distributors and wholesalers nationwide from May 2019 to September 2021.

According to the FDA, N-nitroso-varenicline belongs to the class of nitrosamine compounds, some of which are considered probably carcinogenic to humans (substances that can cause cancer), based on laboratory tests.

“Pfizer is taking this precautionary step,” the company said in its statement. “Long-term ingestion of N-nitroso-varenicline may be associated with a potential theoretical increased risk of cancer in humans.”

According to Pfizer, patients receiving Chantix tablets should contact Stericycle Inc. at 888-276-6166 (Monday to Friday 8:00 a.m. to 5:00 p.m. ET) for return and refund information.

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