Varenicline tablets (Chantix) Shortage

• • 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

• • 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.

• • 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, December 9, 2022; February 17, August 11, 2023; and March 17, 2024.
  2. Chantix Package Insert. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021928s048lbl.pdf#page=22. Published February 2019. Accessed June 28, 2021.