Varenicline as a cause of suicidal outcomes

Nicotine and Tobacco Research

Volumn 18, Issue 1, 2016, Pages 2-9

  Hughes, John R ^a  

^a UNIVERSITY OF VERMONT COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMFEBUTAMONE; NICOTINE DERIVATIVE; NICOTINE PATCH; PLACEBO; VARENICLINE; NICOTINE GUM; NICOTINIC AGENT;

ANXIETY DISORDER; AUTOMUTILATION; COMORBIDITY; CONTROLLED CLINICAL TRIAL (TOPIC); DEPRESSION; DISEASE ASSOCIATION; DRUG FATALITY; DRUG WITHDRAWAL; HUMAN; MENTAL DISEASE; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; POSTMARKETING SURVEILLANCE; POSTTRAUMATIC STRESS DISORDER; PRESCRIPTION; PRIORITY JOURNAL; PSYCHOSIS; QUALITATIVE ANALYSIS; REVIEW; RISK BENEFIT ANALYSIS; SMOKING; SMOKING CESSATION; SUICIDAL BEHAVIOR; SUICIDAL IDEATION; SUICIDE ATTEMPT; SYSTEMATIC REVIEW; TOBACCO DEPENDENCE; WITHDRAWAL SYNDROME; DRUG LABELING; FEMALE; FOOD AND DRUG ADMINISTRATION; PROCEDURES; SUICIDE; UNITED STATES;

DRUG LABELING; FEMALE; HUMANS; NICOTINIC AGONISTS; SMOKING CESSATION; SUICIDE; TOBACCO USE CESSATION PRODUCTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VARENICLINE;

EID: 84954525467     PISSN: 14622203     EISSN: 1469994X     Source Type: Journal    
DOI: 10.1093/ntr/ntu275     Document Type: Review

References (69)

1. Hays JT, Ebbert JO. Varenicline for tobacco dependence. N Engl J Med. 2008;359:2018-2024.
2. Cahill K, Stead LF, Lancaster T. Nicotine receptor partial agonists for smoking cessation. Cochrane Database of Syst Rev. 2012;4:CD006103.
3. Ahmed AIA, Ali ANA, Kramers C, Harmark L, Burger DM, Verhoeven WMA. Neuropsychiatric adverse events of varenicline: a systematic review of published reports. J Clin Psychopharm. 2013;33:55-62.
4. Cahill K, Stead L, Lancaster T. A preliminary benefit-risk assessment of varenicline in smoking cessation. Drug Saf. 2009;32:119-135.
5. McIntyre RS. Varenicline and suicidality: a new era in medication safety surveillance. Expert Opin Drug Saf. 2008;7:511-514.
6. Williams JM, Steinberg MB, Steinberg ML, Gandhi KK, Ulpe R, Foulds J. Varenicline for tobacco dependence: panacea or plight? Expert Opin Pharmacother. 2011;12:1799-1812.
7. Hays JT, Ebbert JO. Adverse effects and tolerability of medications for the treatment of tobacco use and dependence. Drugs. 2010;70:2357-2372.
8. Gordis L. Epidemiology. 3rd ed. Philadelphia, PA: Elsevier Saunders; 2004.
9. Bolton JM, Robinson J. Population-attributable fractions of Axis I and Axis II mental disorders for suicide attempts: findings from a representative sample of the adult, noninstitutionalized US population. Am J Public Health. 2010;100:2473-2480.
10. Evins A. Reassessing the safety of varenicline. Am J Psychiatry. 2013;170:1385-1387.
11. Gibbons RD, Amatya AK, Brown CH, et al. Post-approval drug safety surveillance. Annu Rev Public Health. 2010;31:419-437.
12. Gibbons RD, Mann JJ. Strategies for quantifying the relationship between medications and suicidal behavior. Drug Saf. 2011;34:375-395.
13. Li D, Yang X, Ge Z, et al. Cigarette smoking and risk of completed suicide: a meta-analysis of prospective cohort studies. J Psychiatr Res. 2012;46:1257-1266.
14. Shiffman S, Di Marino ME, Sweeney CT. Characteristics of selectors of nicotine replacement therapy. Tob Control. 2005;14:346-355.
15. Hughes JR. Effects of abstinence from tobacco: valid symptoms and time course. Nicotine Tob Res. 2007;9:315-327.
16. Kasza KA, Cummings M, Carpenter MJ, Cornelius ME, Hyland AJ, Fong GT. Use of stop-smoking medications in the United States before and after the introduction of varenicline. Addiction. 2014.
17. Institute for Safe Medication Practices. Strong safety signal seen for new varenicline risks. 2008. www.ismp.org/docs/vareniclineStudy.asp. Accessed December 12, 2014.
18. Kuehn B. Studies linking smoking-cessation drug with suicide risk spark concerns. JAMA. 2009;301:1007-1008.
19. Institute for Safe Medication Practices. Quarter Watch: 2008 Quarter 1. 2008.
20. Moore TJ, Fudala PJ. Risk of psychiatric side effects with varenicline. Brit Med J. 2009;339:1272-1273.
21. Moore TJ, Glenmullen J, Furberg CD. Thoughts and acts of aggression/violence toward others reported in association with varenicline. Ann Pharmacother. 2010;44:1389-1393.
22. Institute for Safe Medication Practices. Quarter Watch: 2010 Quarter 3. 2011.
23. Moore TJ, Furberg CD, Glenmullen J, Maltsberger JT, Singh S. Suicidal behavior and depression in smoking cessation treatments. PLoS One. 2011;6:e27016.
24. Stapleton J. Do the 10 UK suicides among those taking the smoking cessation drug varenicline suggest a causal link? Addiction. 2009;104:864-865.
25. Sudak HC. Psychiatric emergencies. In Sadock BJ, Sadock VA eds. Kaplan & Sadock's Comprehensive Testbook of Psychiatry. 7th ed. New York, NY: Lippincott Williams and Wilkins; 1999.
26. Popkin M. Exacerbation of recurrent depression as a result of treatment with varenicline. Am J Psychiatry. 2008;165:774.
27. Spirling LI, Stapleton JA, Sutherland G. Suicidal ideation and varenicline: a possible case of mistaken adverse drug reaction? J Clin Psychiatry. 2008;69:1834-1835.
28. Morstad A, Kutscher E, Carnahan R, Klugh Kennedy W. Hypomania with agitation associated with varenicline use in bipolar II disorder. Ann Pharmacother. 2008;42:288-289.
29. Kintz P, Evans J, Villain M, Cirimele V. Smoking cessation with varenicline: a suicidal fatality. J Anal Toxicol. 2009;33:118-120.
30. Karam-Hage M, Shah KR, Cinciripini PM. Addition of bupropion SR to varenicline alleviated depression and suicidal ideation: a case report. Prim Care Companion J Clin Psychiatry. 2010;12.
31. Kutscher EC, Stanley M, Oehlke K. Chantix-induced mental health status changes in a young healthy female. S D J Med. 2009;62:192-195.
32. Cantrell M, Argo T, Haak L, Janney L. Adverse neuropsychiatric events associated with varenicline use in veterans: a case series. Issues Ment Health Nurs. 2012;33:665-669.
33. Stove CP, De Letter EA, Piette MH, Lambert WE. Fatality following a suicidal overdose with varenicline. Int J Legal Med. 2013;127:85-91.
34. Tonstad S, Davies S, Flammer M, Russ C, Hughes J. Psychiatric adverse events in randomized, placebo-controlled clinical trials of varenicline. Drug Saf. 2010;33:289-301.
35. Gibbons RD, Mann JJ. Varenicline, smoking cessation, and neuropsychiatric adverse events. Am J Psychiatry. 2013;170:1460-1467.
36. Crosby AE, Han B, Ortega LAG, Parks S, Gfroerer J. Suicidal thoughts and behaviors among adults aged >18 years-United States, 2008-2009. MMWR. 2011;60:1-22.
37. Hughes JR. Smoking and suicide: a brief overview. Drug Alcohol Depend. 2008;98:169-178.
38. Shiffman S, Brockwell S, Pillitteri J, Gitchell J. Individual differences in adoption of treatment for smoking cessation: demographic and smoking history characteristics. Drug Alcohol Depend. 2008;93:121-131.
39. Kasliwal R, Wilton LV, Shakir SAW. Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. Drug Saf. 2009;32:499-507.
40. Harrison-Woolrych M. Varenicline and suicide. Safety data from New Zealand. BMJ. 2009;339:b5654.
41. Harrison-Woolrych M, Ashton J. Psychiatric adverse events associated with varenicline: an intensive postmarketing prospective cohort study in New Zealand. Drug Saf. 2011;34:763-772.
42. Buggy Y, Cornelius V, Fogg C, Kasliwal R, Layton D, Shakir SAW. Neuropsychiatric events with varenicline: a modified prescriptionevent monitoring study in general practice in England. Drug Saf. 2013;36:521-531.
43. Halperin AC, McAfee TA, Jack LM, et al. Impact of symptoms experienced by varenicline users on tobacco treatment in a real world setting. J Subst Abuse Treat. 2009;36:428-434.
44. Cowan CM, Wink JS, DeZee KJ. Use of the Patient Health Questionnaire-2 to predict suicidal ideations in patients taking varenicline. Am J Addict. 2012;21:356-362.
45. Andreas S, Chenot JF, Diebold R, Peachey S, Mann K. Effectiveness of varenicline as an aid to smoking cessation in primary care: an observational study. Eur Addict Res. 2013;19:47-54.
46. Ferketich AK, Diaz P, Browning KK, et al. Safety of varenicline among smokers enrolled in the lung HIV study. Nicotine Tob Res. 2013;15:247-254.
47. Nahvi S, Wu B, Richter KP, Bernstein SL, Arnsten JH. Low incidence of adverse events following varenicline initiation among opioid dependent smokers with comorbid psychiatric illness. Drug Alcohol Depend. 2013;132:47-52.
48. Cahill K, Stevens S, Perera R, Lancaster T. Pharmacological interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev. 2013;5:CD009329.
49. Foulds J, Russ C, Yu C, et al. Effect of varenicline on individual nicotine withdrawal symptoms: a combined analysis of eight rendomized placebocontrolled trials. Nicotine Tob Res. 2013;15:1849-1857.
50. Valenstein M, Kim MH, Ganoczy D, et al. Antidepressant agents and suicide death among US Department of Veterans Affairs patients in depression treatment. J Clin Psychopharmacol. 2012;32:346-353.
51. Gunnell D, Irvine D, Wise L, Davies C, Martin RM. Varenicline and suicidal behaviour: a cohort study based on data from the General Practice Research Database. BJM. 2009;339:b3805.
52. Thomas KH, Martin RM, Davies NM, Metcalfe C, Windmeijer F, Gunnell D. Smoking cessation treatment and risk of depression, suicide, and self harm in the Clinical Practice Research Datalink: prospective cohort study. BMJ. 2013;347:f5704.
53. Pasternak B, Svanström H, Hviid A. Use of varenicline versus bupropion and risk of psychiatric adverse events. Addiction. 2013;108:1336-1343.
54. Meyer TE, Taylor LG, Xie S, et al. Neuropsychiatric events in varenicline and nicotine replacement patch users in the Military Health System. Addiction. 2012;108:203-210.
55. Cerimele JM, Durango A. Does varenicline worsen psychiatric symptoms in patients with schizophrenia or schizoaffective disorder? A review of published studies. J Clin Psychiatry. 2012;73:e1039-e1047.
56. Kishi T, Iwata N. Varenicline for smoking cessation in people with schizophrenia: systematic review and meta-analysis. Eur Arch Psychiatry Clin Neurosci. 2014. doi:10.1007/s00406-014-0551-3
57. Lorenz RA, Whitley HP, McCoy EK. Safety of varenicline in patients with mental illness. Primary Psychiatry. 2010;17:60-66.
58. Purvis T, Nelson L, Mambourg S. Varenicline use in patients with mental illness: an update of the evidence. Expert Opin Drug Saf. 2010;9:471-482.
59. Purvis T, Mambourg S, Balvanz TM, Magallon HE, Pham RH. Safety and effectiveness of varenicline in a veteran population with a high prevalence of mental illness. Ann Pharmacother. 2009;43:862-867.
60. Tsoi D, Porwal M, Webster AC. Interventions for smoking cessation and reduction in individuals with schizophrenia. Cochrane Database Syst Rev. 2013;2:CD007253.
61. Yousefi MK, Folsom TD, Fatemi SH. A review of varenicline's efficacy and tolerability in smoking cessation studies in subjects with schizophrenia. J Addict Res Ther. 2011;4. doi: 10.4172/2155-6105.S4-001
62. Williams JM, Anthenelli RM, Morris CD, et al. A randomized, doubleblind, placebo-controlled study evaluating the safety and efficacy of varenicline for smoking cessation in patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2012;73:654-660.
63. Evins AE, Cather C, Pratt SA, et al. Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder. JAMA. 2014;311:145-154.
64. Anthenelli RM, Morris C, Ramey TS, et al. Effects of varenicline on smoking cessation in adults with stably treated current or past major depression. Ann Intern Med. 2013;159:390-400.
65. Hill AB. The environment and disease: association or causation? Proc R Soc Med. 1965;58:295-300.
66. McCall W, Black CG. The link between suicide and insomnia: theoretical mechanisms. Curr Psychiatry Rep. 2013;15:383.
67. Philip NS, Carpenter LL, Tyrka AR, Price LH. Nicotinic acetylcholine receptors and depression: a review of the preclinical and clinical literature. Psychopharmacology. 2010;212:1-12.
68. Rollema H, Hajós M, Seymour P, et al. Preclinical pharmacology of the alpha4beta2 nAChR partial agonist varenicline related to effects on reward, mood and cognition. Biochem Pharmacol. 2009;78:813-824.
69. Ziedonis D, Hitsman B, Beckham J, et al. Tobacco use and cessation in psychiatric disorders: National Institute of Mental Health report. Nicotine Tob Res. 2008;10:1691-1715.