Pfizer has expanded its nationwide recall of the smoking cessation drug varenicline (Chantix) to the consumer level to include all lots of the 0.5-mg and 1-mg tablets in the United States because the drug includes higher than acceptable levels of a known carcinogen.
A company announcement posted on the US Food and Drug Administration (FDA) website notes the tablets are being recalled due to the presence of N-nitroso-varenicline, a nitrosamine impurity, at or above the FDA’s current acceptable intake limit.
As previously reported by Medscape Medical News, Pfizer previously recalled some specific lots of Chantix for this same reason back in July and August. Pfizer said it has not received reports of adverse events related to this recall.
With alternative suppliers of Chantix approved in the United States, Pfizer said it is recalling all batches of Chantix as a “precautionary measure.”
Pfizer said consumers who have Chantix on hand should contact Stericycle at 1-888-276-6166 to start the return process.
Patients currently taking Chantix are advised to consult with their healthcare provider about alternative treatment options.
Although N-nitroso-varenicline may be associated with a potential increased cancer risk, there is no immediate risk to patients taking this medication, the FDA says.
The agency also says the health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.
“To lessen the impact to patients from a drug shortage due to this ongoing recall, FDA will not object to certain manufacturers distributing varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit of 37 ng per day but below the interim acceptable intake limit of 185 ng per day until the impurity can be eliminated or reduced to acceptable levels,” the FDA notes.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program.