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7/21/2021

Varenicline tablets (Chantix)

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.[1]

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, 2021.
    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 July 21, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 24, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

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Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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