Chantix, manufactured by Pfizer, is an anti-smoking medication that was recalled in July 2021 after tests found high levels of a cancer-causing chemical impurity.
UPDATE: Pfizer Expands Chantix Recall After Finding Carcinogens
In August 2021, Pfizer expanded a Chantix recall to include 4 more lots after finding high levels of cancer-causing chemicals called nitrosamines. In total, Pfizer has now issued warnings for 16 lots of Chantix that were distributed to wholesalers in the U.S. and Puerto Rico from June 2019 to June 2021.
Chantix Recalled Due to Risk of Cancer
In July 2021, Pfizer recalled certain lots of Chantix after tests found high levels of a cancer-causing chemical known as a nitrosamine. The chemical is an impurity in Chantix called N-nitroso-varenicline, which is believed to cause cancer in humans. “Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans,” according to the recall.
The list of recalled Chantix include:
- 56-count bottles of Chantix 0.5-mg tablets with Lot #00019213 and expiration date January 2022
- 56-count bottles of Chantix 0.5-mg tablets with Lot #EC6994 and expiration date May 2023
- 56-count bottles of Chantix 1-mg tablets with Lot #EA6080 and expiration date March 2023
- 56-count bottles of Chantix 1-mg tablets with Lot #EC9843 and expiration date March 2023.
Pfizer also recalled 8 lots of Chantix cartons with one blister pack of 0.5 mg tablets and one blister pack of 1 mg tablets due to high levels of nitrosamine chemicals. The full list of recalled medications are in the recall.
What is Chantix?
Chantix was approved by the FDA in 2006 as a smoking cessation medication. Chantix works by blocking the effect that nicotine has on the brain. This reduces cravings for and decreases the pleasurable effects of cigarettes and other tobacco products. It was designed to work in conjunction with behavior modification therapy to help people work through their tobacco addiction.
Chantix Linked to Suicidal Thoughts and Heart Attacks
In November 2007, the FDA issued an early communication regarding reports of suicide and severe suicidal thoughts which have been associated with Chantix. Doctors we unfortunately not warned by Pfizer of these severe side effects. In July 2011 and December 2012, the FDA again updated the label to warn about a possible increased risk of heart attack, stroke, and death.