Chantix Recall Expanded To U.S. Products Due To N-Nitroso Varenicline Contamination
Following a recent announcement that Pfizer would halt production of the stop-smoking drug Chantix, due to the presence of potentially cancer-causing chemicals, the manufacturer has announced a recall for 12 lots of the drug sold in the United States.
The FDA announced the Chantix recall on July 19, indicating batches of the drug contain levels of a chemical known as N-nitroso-varenicline at amounts which exceed an Acceptable Daily Intake (ADI) level set by Pfizer itself. While unverified, it is believed the chemical is a cancer risk to humans.
Chantix (varenicline) is a prescription medication introduced by Pfizer in 2006, designed to help people quit smoking. However, less than three years after its release, the FDA required Pfizer to add a “black box” warning, following a number of reports involving suicide and other unusual behavior among users. The FDA rescinded the label requirement and removed the warning in December 2016.
Did You Know? Millions of Philips CPAP Machines Recalled
Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.Learn More
The recall comes after the manufacturer announced it was halting Chantix distribution in June, when the drug became the latest linked to a class of cancer-causing chemicals known as nitrosamines. It announced a recall in Canada at the time, but not one in the United States.
Over the last few years, several drugs, such as Zantac, valsartan and metformin, have faced similar recalls, primarily to do the presence of a nitrosamine known as N-Nitrosodimethylamine (NDMA).
Pfizer indicates it has received no reports of adverse events linked to this recall, and the FDA is not calling on users to stop taking the drug.
“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,” Pfizer said in the recall announcement. “The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”
The recall for Chantix affects two lots of 0.5 mg Tablets, two lots of 1 mg Tablets, and eight lots of a Chantix kit of 0.5/1 mg Tablets. A complete list of NDCs, lot numbers and expiration dates are included in the recall notice.
Pfizer has instructed wholesalers and distributors to stop use and distribution of these products and quarantine them immediately. They, and patients, have been instructed to contact Stericycle at 888-276-6166 for information on how to return the product and obtain a reimbursement.
Those who received free Chantix through the Pfizer Patient Assistance Protram (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP) have been instructed to request replacement product by calling 833-203-2776.
KarimOctober 19, 2021 at 8:16 pm
Last April I was advised by my doctor to take one box of CHANTIX 0.5/1.0 mg for one month and two boxes of CHANTIX 1.0 mg for two months supply to quit smoking, so I bought them from CVS in Miami, they cost mi almost a fortune, I already finished all of the three months tablets, I am worried about what I am reading today about CHANTIX since my three boxes are from the lots that Pfizer recalled fro[Show More]Last April I was advised by my doctor to take one box of CHANTIX 0.5/1.0 mg for one month and two boxes of CHANTIX 1.0 mg for two months supply to quit smoking, so I bought them from CVS in Miami, they cost mi almost a fortune, I already finished all of the three months tablets, I am worried about what I am reading today about CHANTIX since my three boxes are from the lots that Pfizer recalled from the market.
"*" indicates required fields
More Top Stories
The President has signed the Camp Lejeune Justice Act into law as part of a larger package of veterans toxic chemical exposure health care benefits, which will allow those exposed to water contamination while living or serving on the base to file lawsuits against the federal government.
Ahead of the first Zantac lawsuit trials, slated to begin next year, investors sold off Sanofi, GlaxoSmithKline and Pfizer stocks, anticipating massive court losses and costs.
A federal judge has issued a pretrial scheduling order setting the first Nexium kidney damage lawsuit to go before a jury in November.