Pfizer has announced an expansion of its Chantix recall that now covers all lots of the tablets. The reason is one we’ve heard before — these tablets potentially have too high of an impurity called N-nitroso-varenicline that has been linked to the potential development of certain cancers when ingested over a long period of time.
The expanded recall covers all lots of Pfizer’s Chantix 0.5mg and 1mg tablets made available at the consumer level. Chantix is a drug that is used to help smokers kick the habit; it has been on the market for many years and is intended for short-term use. As with some other medication recalls we’ve seen in recent years, this latest one is due to an impurity.
N-nitroso-varenicline is a nitrosamine impurity that, if ingested in too high of quantities over a long period of time, may be a cancer risk in humans. Nitrosamine compounds are found in food and water, which makes it difficult to completely remove the impurity from drugs.
The FDA has established a maximum intake limit for the compounds; Pfizer says this recall is because the N-nitroso-varenicline in these Chantix tablets may be at or above the FDA limit. Pfizer says in its recall notice that the impurity doesn’t present an “immediate risk to patients” who are taking the tablets.
The company goes on to point out that smoking cigarettes is a major cancer risk, going on to state:
Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their healthcare provider about alternative treatment options. To date, Pfizer has not received reports of adverse events assessed to be related to this recall.
Pictures of the recalled Chantix products, as well as a list with expiration dates and other identifying details, can be found in the company’s press release.