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Anti-Smoking Drug Chantix Recalled for High Levels of Carcinogens

Product recall

Pfizer is recalling batches of its anti-smoking drug Chantix after an increased level of impurities that can cause cancer were discovered in the medication.  According to a report on, the nationwide recall includes two lots of Chantix 0.5 mg tablets, two lots of Chantix 1 mg tablets and eight lots of a Chantix kit of 0.5 mg/1 mg tablets. Prolonged ingestion of the discovered impurities can result in serious long-term damage and drastic side effects.

Details of the Recall

Pfizer said in its recall announcement that this was due to the presence of a nitrosamine, N-nitroso-varenicline, above Pfizer’s established Acceptable Daily Intake level. Long- term ingestion of this nitrosamine may be associated with a potentially heightened risk of cancer in humans, but there is no immediate risk to patients taking this medication, according to the drug manufacturer. It also added that the health benefits of stopping smoking outweigh the potential cancer risk.

The U.S. Food and Drug Administration (FDA) recommends that patients prescribed batches of the drugs affected by this recall continue taking their medicine until their pharmacist provides a replacement or their doctor prescribes a different drug that treats the same condition.

The FDA has classified some nitrosamines (including N-nitroso-varenicline) as “possible human carcinogens.” While most of us are exposed to some level of nitrosamines, which are present in water and foods, nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.

The Danger of Defective Drugs

Product manufacturers have a duty and a legal obligation to manufacture safe and effective products. In this case, a drug intended to help consumers quit smoking could potentially cause cancer. This is indeed a serious drug effect that must be addressed.

When dangerous drugs cause serious side effects, consumers can file what is known as a product liability lawsuit seeking compensation for any losses they may have sustained. In such cases, consumers also have the right to file what is known as a class action lawsuit to hold these large corporations accountable for their negligence.

An experienced product defect attorney will be able to help you determine the course of action that is appropriate for your case. The best product defect law firms always offer a free consultation and comprehensive case evaluation to victims and their families.


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California Personal Injury Blog