This article is available to members only. Please enjoy the abstract for free. Subscribe for instant access to the full article.

This content is restricted to subscribers

Continue Reading...

Did you know members enjoy unlimited free PDF downloads as part of their subscription? Subscribe today for instant access to this article and our entire library in your preferred format. Alternatively, you can purchase the PDF of this article individually.

Subscribe Now

Already a member? Login

  1. Department of Psychiatry, University of Michigan, Ann Arbor, Michigan
  2. Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan
  3. Corresponding author: Lauren B. Gerlach, DO, MS, University of Michigan—Department of Psychiatry, 4250 Plymouth Rd, Ann Arbor, MI 48109 ([email protected]).
  4. Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan
  5. Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan
  6. Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan
  7. Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan
  8. Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan
  9. Department of Epidemiology and Biostatistics, Michigan State University, East Lansing, Michigan
  10. Department of Psychiatry, University of Michigan, Ann Arbor, Michigan
  11. Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan
  12. Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan
  1. US Food & Drug Administration. Public Health Advisory: Important Information on Chantix (varenicline). FDA website. http://wayback.archive-it.org/7993/20170112032505/http:/www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm051136.htm. February 2008 (online). Accessed July 1, 2020.
  2. US Food & Drug Administration. Public Health Advisory: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban. FDA website. http://wayback.archive-it.org/7993/20170112005513/http:/www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm169988.htm. July 2009 (online). Accessed July 1, 2020.
  3. Meyer TE, Taylor LG, Xie S, et al. Neuropsychiatric events in varenicline and nicotine replacement patch users in the Military Health System. Addiction. 2013;108(1):203–210. PubMed CrossRef
  4. Pasternak B, Svanström H, Hviid A. Use of varenicline versus bupropion and risk of psychiatric adverse events. Addiction. 2013;108(7):1336–1343. PubMed CrossRef
  5. Thomas KH, Martin RM, Davies NM, et al. Smoking cessation treatment and risk of depression, suicide, and self harm in the Clinical Practice Research Datalink: prospective cohort study. BMJ. 2013;347(Oct 11):f5704. PubMed CrossRef
  6. Cunningham FE, Hur K, Dong D, et al. A comparison of neuropsychiatric adverse events during early treatment with varenicline or a nicotine patch. Addiction. 2016;111(7):1283–1292. PubMed CrossRef
  7. Anthenelli RM, Benowitz NL, West R, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet. 2016;387(10037):2507–2520. PubMed CrossRef
  8. Peckham E, Brabyn S, Cook L, et al. Smoking cessation in severe mental ill health: what works? an updated systematic review and meta-analysis. BMC Psychiatry. 2017;17(1):252. PubMed CrossRef
  9. Anthenelli RM, Morris C, Ramey TS, et al. Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial. Ann Intern Med. 2013;159(6):390–400. PubMed CrossRef
  10. Evins AE, Cather C, Pratt SA, et al. Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder: a randomized clinical trial. JAMA. 2014;311(2):145–154. PubMed CrossRef
  11. US Food & Drug Administration. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. FDA website. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-revises-description-mental-health-side-effects-stop-smoking. December 2016 (online). Accessed July 3, 2020.
  12. Shah D, Shah A, Tan X, et al. Trends in utilization of smoking cessation agents before and after the passage of FDA boxed warning in the United States. Drug Alcohol Depend. 2017;177:187–193. PubMed CrossRef
  13. Desai RJ, Good MM, San-Juan-Rodriguez A, et al. Varenicline and nicotine replacement use associated with US Food and Drug Administration Drug Safety Communications. JAMA Netw Open. 2019;2(9):e1910626. PubMed CrossRef
  14. Kizer KW, Dudley RA. Extreme makeover: Transformation of the veterans health care system. Annu Rev Public Health. 2009;30(1):313–339. PubMed CrossRef
  15. Barnett P, Chow A, Flores N. Using tobacco health factors data for VA Health Services Research. Menlo Park, CA: VA Palo Alto;2014.
  16. McGinnis KA, Brandt CA, Skanderson M, et al. Validating smoking data from the Veteran’s Affairs Health Factors dataset, an electronic data source. Nicotine Tob Res. 2011;13(12):1233–1239. PubMed CrossRef
  17. Ignacio RV, Barnett PG, Kim HM, et al. Trends and patient characteristics associated with tobacco pharmacotherapy dispensed in the Veterans Health Administration. Nicotine Tob Res. 2018;20(10):1173–1181. PubMed CrossRef
  18. Dusetzina SB, Higashi AS, Dorsey ER, et al. Impact of FDA drug risk communications on health care utilization and health behaviors: a systematic review. Med Care. 2012;50(6):466–478. PubMed CrossRef
  19. Gerlach LB, Kim HM, Yosef M, et al. Assessing responsiveness of health systems to drug safety warnings. Am J Geriatr Psychiatry. 2018;26(4):476–483. PubMed CrossRef
  20. Wagner AK, Chan KA, Dashevsky I, et al. FDA drug prescribing warnings: is the black box half empty or half full? Pharmacoepidemiol Drug Saf. 2006;15(6):369–386. PubMed CrossRef
  21. Briesacher BA, Soumerai SB, Zhang F, et al. A critical review of methods to evaluate the impact of FDA regulatory actions. Pharmacoepidemiol Drug Saf. 2013;22(9):986–994. PubMed CrossRef
  22. Sales MM, Cunningham FE, Glassman PA, et al. Pharmacy benefits management in the Veterans Health Administration: 1995 to 2003. Am J Manag Care. 2005;11(2):104–112. PubMed
  23. Aspinall SL, Sales MM, Good CB, et al. Pharmacy benefits management in the veterans health administration revisited: a decade of advancements, 2004–2014. J Manag Care Spec Pharm. 2016;22(9):1058–1063. PubMed
  24. VA Center for Medication Safety Tobacco Use Cessation Technical Advisory Group. Varenicline Criteria for Prescribing. https://www.healthquality.va.gov/tuc/VareniclineCriteriaforPrescribing.pdf. Published July 2011. Accessed September 1, 2020.
  25. Medication Safety in Seconds: A Monthly Publication from VA MedSafe: VA’s Comprehensive Pharmacovigilance Center. Issue 10, Volume 6. VAMedSafe website. https://www.pbm.va.gov/PBM/vacenterformedicationsafety/newsletter/MedicationSafetyinSeconds_NovDec_2016_FINAL.PDF. Accessed June 1, 2021.
  26. Hickson RP, Cole AL, Dusetzina SB. Implications of Removing Rosiglitazone’s Black Box Warning and Restricted Access Program on the Uptake of Thiazolidinediones and Dipeptidyl Peptidase-4 Inhibitors Among Patients with Type 2 Diabetes. J Manag Care Spec Pharm. 2019;25(1):72–79. PubMed CrossRef
  27. Prices for smoking cessation drug Chantix increase by 106% in just five years. GoodRx website. https://www.goodrx.com/blog/prices-for-smoking-cessation-drug-chantix-increase-by-106-in-just-five-years/ Published June 25, 2018. Accessed June 1, 2021.