title: Neuropsychiatric adverse events of varenicline: a systematic review of published reports.
abstract: BACKGROUND
  Over the past years, the impact of varenicline in patients with mental illness has been debated as serious neuropsychiatric adverse events (AEs) have been reported with varenicline use.
  
  
  OBJECTIVE
  To identify and summarize published case reports of neuropsychiatric AEs ascribed to varenicline and to determine potential risk factors for these AEs.
  
  
  METHODS
  A literature search of MEDLINE, the Cochrane Library, EMBASE, and PsychInfo database was conducted for case reports concerning the neuropsychiatric AEs of varenicline published in English from 2006 (approval year by the US Food and Drug Administration and the Dutch Medicines Evaluation Board) to January 1, 2012.
  
  
  RESULTS
  We identified 25 published cases. In most reports, patients had been admitted to psychiatric hospitals with serious neuropsychiatric AEs due to varenicline. The average patient age was 46.4 years, and 56% were men; 68% of patients had a psychiatric history. The onset of symptoms started 2 days to 3 months after the initiation of varenicline. One report described completed suicide in a man with no psychiatric history. In most cases (84%), the neuropsychiatric symptoms resolved after the discontinuation of varenicline. Analysis of all reports using the Naranjo causality scale, a method for estimating the probability of adverse drug reactions, indicated probable causality in 76% of the cases and definite causality in 12% of cases.
  
  
  CONCLUSIONS
  Varenicline is associated with an increased risk of serious neuropsychiatric AEs, especially in patients with a psychiatric illness. It is strongly recommended that varenicline be administered only to mentally stable patients and under close monitoring.
authors.affiliation: Department of Elderly, Vincent van Gogh Institute for Psychiatry, Venray, The Netherlands. amirahmed1@hotmail.com
authors.forename: Amir I A
authors.initials: AI
authors.lastname: Ahmed
authors.forename: Abdullah N A
authors.initials: AN
authors.lastname: Ali
authors.forename: Cees
authors.initials: C
authors.lastname: Kramers
authors.forename: Linda V D
authors.initials: LV
authors.lastname: Härmark
authors.forename: David M
authors.initials: DM
authors.lastname: Burger
authors.forename: Willem M A
authors.initials: WM
authors.lastname: Verhoeven
mesh_terms: D000328:Adult; D000368:Aged; D001552:Benzazepines / Q000009:adverse effects*; D015897:Comorbidity; D005260:Female; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000139:chemically induced* / Q000175:diagnosis / Q000523:psychology; D008875:Middle Aged; D018722:Nicotinic Agonists / Q000009:adverse effects*; D011810:Quinoxalines / Q000009:adverse effects*; D018570:Risk Assessment; D012307:Risk Factors; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D013997:Time Factors; D000068580:Varenicline; D055815:Young Adult
chemical_list: D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D000068580:Varenicline