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Varenicline tablets (Chantix)

Last Updated: December 12, 2022
Status: Current

Products Affected - Description
    • Chantix oral tablet, Pfizer, 0.5 mg, bottle, 56 count, NDC 00069-0468-56
    • Chantix oral tablet, Pfizer, 0.5 mg/1 mg, starting month box 0.5 mg = 11 tablets/1 mg = 42 tablets; 53 count, NDC 00069-0471-03
    • Chantix oral tablet, Pfizer, 1 mg, bottle, 56 count, NDC 00069-0469-56
    • Chantix oral tablet, Pfizer, 1 mg, continuing month box 56 count, NDC 00069-0469-03
Reason for the Shortage
    • Pfizer has Chantix on shortage due to a manufacturing delay to evaluate the active ingredient of the product. Pfizer has recalled all presentations of Chantix. More information on the recall can be found at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamine-varenicline-chantix.[1]
    • The generic presentations are not affected by this shortage.
Available Products
    • There are no presentations available

Estimated Resupply Dates

    • Pfizer has Chantix on back order and the company cannot estimate a release date.[1]

Implications for Patient Care

    • FDA is allowing temporary importation Apo-Varenicline (varenicline tartrate) from Apotex in Canada. More information on ordering the product from Apotex through a distributor or wholesaler can be found at https://www.fda.gov/media/150799/download

Safety

    • Abrupt discontinuation of varenicline has been associated with increased irritability and sleep disturbances, suggesting varenicline may produce mild physical dependence.[2]

Alternative Agents & Management

    • There are 3 medications that are primarily used in tobacco smoking cessation. These are nicotine (a variety of forms are available including patches, gum, lozenges, nasal sprays, and oral inhalers), bupropion sustained-release, and varenicline. It is suggested that varenicline is the most effective medication alone or in combination. Links to smoking cessation guidelines that include dosing and combination suggestions of varenicline and alternatives include:
    • American Thoracic Society: https://www.atsjournals.org/doi/full/10.1164/rccm.202005-1982ST
    • American Academy of Family Physicians: https://www.aafp.org/dam/AAFP/documents/patient_care/tobacco/pharmacologic-guide.pdf
    • US Preventive Services Task Force on Tobacco Smoking Cessation: https://www.uspreventiveservicestaskforce.org/uspstf/document/RecommendationStatementFinal/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions

References

    1. Pfizer (personal communication). June 25, September 17, November 24, 2021; February 25, June 1, September 9, and December 9, 2022.
    2. Chantix Package Insert. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021928s048lbl.pdf#page=22. Published February 2019. Accessed June 28, 2021.

Updated

Updated December 12, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 24, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2022, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.