Varenicline and risk of psychiatric conditions, suicidal behaviour, criminal offending, and transport accidents and offences: Population based cohort study

BMJ (Online)

Volumn 350, Issue , 2015, Pages

  Molero, Yasmina ^a   Lichtenstein, Paul ^a   Zetterqvist, Johan ^a   Gumpert, Clara Hellner ^a   Fazel, Seena ^b  

^a KAROLINSKA INSTITUTE   (Sweden)

^b WARNEFORD HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

AMFEBUTAMONE; VARENICLINE; BENZAZEPINE DERIVATIVE; NICOTINE GUM; NICOTINIC AGENT; QUINOXALINE DERIVATIVE;

ADULT; AGED; ALCOHOLISM; ANXIETY DISORDER; ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; CONVICTED CRIME; CRIME; CRIMINAL OFFENDING; DISEASE ASSOCIATION; DRUG MISUSE; EFFECT SIZE; FEMALE; FOLLOW UP; HIGH RISK POPULATION; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; MIDDLE AGED; MOOD DISORDER; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; POPULATION RESEARCH; PRESCRIPTION; PRIORITY JOURNAL; PSYCHOSIS; RISK ASSESSMENT; SENSITIVITY ANALYSIS; SUICIDAL BEHAVIOR; SUICIDE ATTEMPT; SUSPECTED CRIME; SWEDEN; TOBACCO DEPENDENCE; TRAFFIC ACCIDENT; TREATMENT DURATION; YOUNG ADULT; ADOLESCENT; CHEMICALLY INDUCED; EPIDEMIOLOGY; PREVENTION AND CONTROL; SMOKING; SMOKING CESSATION; STATISTICS AND NUMERICAL DATA; SUBSTANCE WITHDRAWAL SYNDROME; SUICIDE;

ACCIDENTS, TRAFFIC; ADOLESCENT; ADULT; AGED; BENZAZEPINES; COHORT STUDIES; CRIME; EPIDEMIOLOGIC METHODS; FEMALE; HUMANS; MALE; MENTAL DISORDERS; MIDDLE AGED; NICOTINIC AGONISTS; QUINOXALINES; SMOKING; SMOKING CESSATION; SUBSTANCE WITHDRAWAL SYNDROME; SUICIDE; TOBACCO USE CESSATION PRODUCTS; VARENICLINE; YOUNG ADULT;

EID: 84936942202     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.h2388     Document Type: Article

References (60)

1. Shafey O, Dolwick S, Guindon GE, eds. Tobacco control country profiles. 2nd ed. American Cancer Society, 2003 (available at www.who.int/tobacco/global-data/country-profiles/en/).
2. Lim SS, Vos T, Flaxman AD, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380:2224-60.
3. World Health Organization. Global health risks: mortality and burden of disease attributable to selected major risks. WHO, 2009.
4. 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.
5. Food and Drug Administration. FDA drug safety communication: safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events. 2011. www.fda.gov/Drugs/DrugSafety/ucm276737.htm.
6. National Institute for Health and Clinical Excellence. NICE implementation uptake report: smoking cessation drugs. NICE, 2010.
7. Food and Drug Administration. FDA issues public health advisory on Chantix. 2008. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116849.htm.
8. Medicines and Healthcare Products Regulatory Agency (MHRA). Varenicline: possible effects on driving; psychiatric illness. Drug Safety Update 2007;1:12.
9. Moore TJ, Furberg CD, Glenmullen J, Maltsberger JT, Singh S. Suicidal behavior and depression in smoking cessation treatments. PLoS One 2011;6:e27016.
10. Kuehn BM. Varenicline gets stronger warnings about psychiatric problems, vehicle crashes. JAMA 2009;302:834.
11. Annagur BB, Bez Y. Varenicline-induced psychotic depressive episode in a patient with bipolar disorder. Ther Adv Psychopharmacol 2012;2:35-7.
12. Cinembre B, Akdag ST, Metin O, Doganavsargil O. Varenicline-induced psychosis. CNS Spectr 2010;15:469-72.
13. DiPaula BA, Thomas MD. Worsening psychosis induced by varenicline in a hospitalized psychiatric patient. Pharmacotherapy 2009;29:852-7.
14. Forcen FE, Martinez FL, Moya AM. Varenicline precipitating psychosis in a patient with no previous psychiatric history: a case report of a Spanish patient who was later diagnosed with paranoid personality disorder. Clin Schizophr Relat Psychoses 2012;5:221-3.
15. Gupta A, Bastiampillai T, Adams M, Nelson, A, Nance, M. Varenicline induced psychosis in schizophrenia. Aust N Z J Psychiatry 2012;46:1009.
16. Aagaard L, Hansen EH. Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011. BMC Pharmacol Toxicol 2013;14:30.
17. Harrison-Woolrych M, Ashton J. Psychiatric adverse events associated with varenicline: an intensive postmarketing prospective cohort study in New Zealand. Drug Saf 2011;34:763-72.
18. Moore TJ, Glenmullen J, Furberg CD. Thoughts and acts of aggression/violence toward others reported in association with varenicline. Ann Pharmacother 2010;44:1389-94.
19. Meyer, TE, Taylor LG, Xie S, et al. Neuropsychiatric events in varenicline and nicotine replacement patch users in the military health system. Addiction 2013;108:203-10.
20. Cincipirini PM, Robinson JD, Karam-Hage M, Minnix JA, Lam C, Versace F. Effects of varenicline and bupropion sustained-release use plus intensive smoking cessation counseling on prolonged abstinence from smoking and on depression, negative affect, and other symptoms of nicotine withdrawal. JAMA Psychiatry 2013;70:522-33.
21. Foulds J, Russ C, Yu C-R, et al. Effect of varenicline on individual nicotine withdrawal symptoms: a combined analysis of eight randomized, placebo-controlled trials. Nicotine Tob Res 2013;15:1849-57.
22. Garza D, Murphy M, Tseng L-J, Riordan HJ, Chatterjee A. A double-blind randomized placebo-controlled pilot study of neuropsychiatric adverse events in abstinent smokers treated with varenicline or placebo. Biol Psychiatry 2011;69:1075-82.
23. Gibbons RD, Mann JJ. Varenicline, smoking cessation, and neuropsychiatric adverse events. Am J Psychiatry 2013;170:1460-7.
24. 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. BMJ 2009;339:b3805.
25. 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.
26. Pasternak B, Svanström H, Hviid A. Use of varenicline versus bupropion and risk of psychiatric adverse events. Addiction 2013;108:1336-43.
27. 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.
28. Tonstad S, Davies S, Flammer M, Russ C, Hughes J. Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis. Drug Saf 2010;33:289-301.
29. Gibbons RD, Amatya AK, Brown CH, et al. Post-approval drug safety surveillance. Annu Rev Public Health 2010;31:419-37.
30. Kalman D, Baker Morissette S, George TP. Co-morbidity of smoking in patients with psychiatric and substance use disorders. Am J Addict 2005;14:106-23.
31. Kuehn BM. New reports examine psychiatric risks of varenicline for smoking cessation. JAMA 2012:307:129-30.
32. Thomas KH, Martin RM, Knipe DW, Higgins JPT, Gunnell D. Risk of neuropsychiatric adverse events associated with varenicline: systematic review and meta-analysis. BMJ 2015;350:h1109.
33. Shim JC, Jung DU, Jung SS, et al. Adjunctive varenicline treatment with antipsychotic medications for cognitive impairments in people with schizophrenia: a randomized double-blind placebo-controlled trial. Neuropsychopharmacology 2012:37:660-8.
34. Chengappa KN, Perkins KA, Brar JS, et al. Varenicline for smoking cessation in bipolar disorder: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2014;75:765-72.
35. 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;159:390-400.
36. 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;311:145-54.
37. Food and Drug Administration. FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events. 2011. www.fda.gov/drugs/drugsafety/ucm276737.htm.
38. Wettermark B, Hammar N, MichaelFored C, et al. The new Swedish Prescribed Drug Register-opportunities for pharmacoepidemiological research and experience from the first six months. Pharmacoepidemiol Drug Saf 2007;16:726-35
39. Hays JT, Ebbert JO. Varenicline for tobacco dependence. N Engl J Med 2008;359:2018-24.
40. National Council for Crime Prevention. Kriminalstatistik 2010 [Criminal statistics 2010]. National Council for Crime Prevention, 2010.
41. Fazel S, Grann M. The population impact of severe mental illness on violent crime. Am J Psychiatry 2006;163:1397-403.
42. Ludvigsson J, Andersson E, Ekbom A, et al. External review and validation of the Swedish national inpatient register. BMC Public Health 2011;11:450.
43. Johansson LA, Westerling R. Comparing Swedish hospital discharge records with death certificates: implications for mortality statistics. Int J Epidemiol 2000;29:495-502.
44. Chang Z, Lichtenstein P, D'Onofrio BM, Sjölander A, Larsson H. Serious transport accidents in adults with attention-deficit/hyperactivity disorder and the effect of medication: a population-based study. JAMA Psychiatry 2014;71:319-25.
45. Chen Q, Sjolander A, Runeson B, D'Onofrio BM, Lichtenstein P, Larsson H. Drug treatment for attention-deficit/hyperactivity disorder and suicidal behaviour: register based study. BMJ 2014;348:g3769.
46. Fazel S, Zetterqvist J, Larsson H, Långström N, Lichtenstein N. Antipsychotics, mood stabilisers, and risk of violent crime. Lancet 2014;384:1206-14.
47. Lichtenstein P, Halldner L, Zetterqvist J, et al. Medication for attention deficit- hyperactivity disorder and criminality. N Engl J Med 2012;367:2006-14.
48. Baek J-H, Eisner L-R, Nierenberg AA. Smoking and suicidality in subjects with major depressive disorder: results from the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). J Affect Disord 2013;150:1158-66.
49. Dakwar E, Popii M, Coccaro EF. Lifetime history of cigarette smoking associated with aggression and impulsivity in both healthy and personality disordered volunteers. J Pers Disord 2011;25:645-55.
50. Holma IA, Holma KM, Melartin TK, Ketokivi M, Isometsa ET. Depression and smoking: a 5-year prospective study of patients with major depressive disorder. Depress Anxiety 2013;30:580-8.
51. Schneider B, Lukaschek K, Baumert J, Meisiner M, Erazo N, Ladwig K-H. Living alone, obesity, and smoking increase risk for suicide independently of depressive mood findings from the population-based MONICA/KORA Augsburg cohort study. J Affect Disord 2014;152-154:416-21.
52. Mayet A, Nivoix P, Haus-Cheymol R, et al. Increase in reported adverse events following seasonal influenza vaccination among the French armed forces, 2008-2009: possible role of stimulated reporting and background cases of influenza-like infection. Public Health 2012;126:70-6.
53. Institute of Safe Medicine Practices. Strong safety signal seen for new varenicline risks. 2008. www.ismp.org/docs/vareniclinestudy.asp.
54. Yiengprugsawan V, Berecki-Gisolf J, Bain C, McClure R, Seubsman S-A, Sleigh AC. Predictors of injury mortality: findings from a large national cohort in Thailand. BMJ Open 2014;4:e004668.
55. Wen CP, Tsai SP, Cheng TY, Chan HT, Chung WS, Chen CJ. Excess injury mortality among smokers: a neglected tobacco hazard. Tob Control 2005;14(suppl 1):i28-32.
56. Hughes JR. Smoking and suicide: a brief overview. Drug Alcohol Depend 2008;98:169-78.
57. Kaur K, Kaushal S, Chopra SC. Varenicline for smoking cessation: a review of the literature. Curr Ther Res Clin Exp 2009;70:35-54.
58. Ahmed AI, Ali AN, Kramers C, Ha¨rmark LV, Burger DM, Verhoeven WM. Neuropsychiatric adverse events of varenicline: a systematic review of published reports. J Clin Psychopharmacol 2013;33:55-62.
59. Ng M, Freeman MK, Fleming TD, et al. Smoking prevalence and cigarette consumption in 187 countries, 1980-2012. JAMA 2014;311:183-92.
60. Organisation for Economic Co-operation and Development. Health at a glance: Europe 2012. OECD Publishing, 2012 (available at http://dx.doi.org/10.1787/9789264183896-en).