Inpharma 1640 - 31 May 2008

ISMP highlights safety concernsfor varenicline

A report by the US Institute for Safe MedicationPractices (ISMP) has raised concerns about the safety ofthe smoking cessation drug varenicline [Chantix].1

The ISMP explains that, in the fourth quarter of 2007,varenicline accounted for 988 serious injuries reportedto the US FDA, which was greater than any other drugduring this time period. This large number of reportsprompted the ISMP to conduct an analysis of all USserious adverse event reports for varenicline from thetime of its marketing approval in 2006. A total of3063 reports were included in the analysis.

The study identified 227 reports of suicidal acts,thoughts or behaviours, 397 cases of psychosis/psychotic disorders and 525 reports of hostility/aggression. The ISMP found that, in addition topsychiatric symptoms, which have been the subject of aprevious FDA advisory, adverse event reports forvarenicline described other types of serious events.Most notably were accidents and injuries due to causessuch as confusion and loss of consciousness (n = 173),vision disorders (148), cardiac arrhythmias (224),seizures (86), movement disorders (372), angioedema(338), and hyperglycaemia/diabetes mellitus (544). TheISMP has immediate concerns about the use ofvarenicline in people operating aircraft, trains, buses andother vehicles, or in situations where a lapse in alertnessor motor control could result in serious injury.

Chantix banned by the FAAAccording to Newswire, the Federal Aviation

Administration (FAA) has issued an immediate ban onthe use of Chantix by pilots and air traffic controllers,following the ISMP’s findings. 2

1. Institute for Safe Medication Practices. Strong safety signal seen for newvarenicline risks. Internet Document : [13 pages], 23 May 2008. Available from:URL: http://www.ismp.org.

2. Cory Watson Crowder & DeGaris. Litigation Predicted in Wake of FAA Ban ofChantix Use by Pilots and Air Traffic Controllers: Smoking Cessation DrugTarget of Controversy. Media Release : 22 May 2008. Available from: URL:http://www.prnewswire.com.

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» Editorial comment: Pfizer has previously updated the labelfor Chantix [varenicline] to include warnings about the risk ofserious neuropsychiatric symptoms. The EMEA hasrecommended including information about the risk ofdepression on the varenicline label. Furthermore, the UK MHRAand the US FDA have previously advised healthcareprofessionals about the possible risks of suicidal ideation andother behavioural and mood disorders associated withvarenicline use.

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Inpharma 31 May 2008 No. 16401173-8324/10/1640-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved