Chantix Recall Expanded Yet Again After Pfizer Discovers More Carcinogen-Tainted Lots

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Chantix Recall Overview:

• Who: Pfizer, the maker of Chantix, is expanding its recall of the smoking cessation medication. 
• Why: Pfizer, which already recalled some lots of Chantix, is recalling another four due to potentially unsafe levels of nitrosamine, a carcinogen..
• Where: The recalled lots were distributed across the United States and Puerto Rico between June 2019 and June 2021.

Pfizer is recalling another four lots of the smoking cessation medication Chantix (Varenicline) to include a total of 16 lots that may contain unsafe levels of a nitrosamine, N-nitroso-varenicline — a carcinogen. 

The most recent additions to the Chantix recall can be seen in the complete list of recalled products here. The previous recall in July expanded the recalled products to a total of 12 lots. 

The recall affects Chantix sold at the consumer level, according to a previous announcement by the Food and Drug Administration (FDA).  

“Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options,” Pfizer said.  

It said the health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.

“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.”

To date, Pfizer had not received any reports of adverse events related to the recall, it said .

On June 24, Pfizer issued the first recall. The drug maker announced on June 24 that it had discovered levels of N-nitrosodimethylamine — a known cancer-causing agent that is also known as NDMA — that are above an “acceptable” level of daily intake. 

“Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified their direct consignees by letter to arrange for return of any recalled product,” said the company in its first Chantix recall announcement. 

Pfizer says that it has instructed wholesalers and distributors to stop using and quarantine the recalled lots and is setting up a way for consumers to return the recalled Chantix.  

This latest recall expansion is not the first time Chantix has been linked to adverse health effects. Since the drug was introduced, Chantix users have reported psychological side effects such as depression, aggression, homicidal tendencies, entertaining the thought of suicide, and even suicide attempts. 

Pfizer has faced a number of lawsuits by Chantix users and their family members who say that the drug caused severe depression and even resulted in suicide. Others have claimed that the drug caused severe psychological side effects, including blackouts that landed one Chantix user in jail.  

In 2009, the FDA placed a “black box” warning label on Chantix informing users that recent data showed the smoking cessation drug can cause depression, suicidal thoughts, attempted suicide, aggression and anger. 

Two years later, in June 2011, the FDA updated the Chantix side effects warning again to include heart attack and other severe cardiovascular events. 

Top Class Actions will continue to monitor the Chantix recall and keep readers updated with any developments.  

Have you used Chantix? Are you concerned about the recall? Tell us about it in the comment section below.

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