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Nicotine & Tobacco Research Advance Access published online on March 26, 2009
Nicotine & Tobacco Research, doi:10.1093/ntr/ntp005
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© The Author 2009. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org.

Adverse effects with use of nicotine replacement therapy among quitline clients

Deborah J. Ossip, Sara M. Abrams, Martin C. Mahoney, Dana Sall and K. Michael Cummings

Deborah J. Ossip, Ph.D., Department of Community and  Preventive Medicine, University of Rochester Medical Center, Rochester, NY
Sara M. Abrams, M.P.H., Department of Health Behavior, Roswell Park Cancer Institute, Buffalo, NY
Martin C. Mahoney, M.D., Ph.D., Department of Health Behavior, Roswell Park Cancer Institute, Buffalo, NY
Dana Sall, B.S., Department of Community and Preventive Medicine, University of Rochester Medical Center, Rochester, NY
K. Michael Cummings, Ph.D., M.P.H., Department of Health Bhavior, Roswell Park Cancer Institute, Buffalo, NY

Corresponding Author: K. M. Cummings, Ph.D., M.P.H., Chairman, Department of Health Behavior, Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY 14263, USA. Telephone: 716-845-8456. Fax: 716-845-8487. Email: michael.cummings{at}roswellpark.org


  Abstract

Introduction: Nicotine replacement therapy (NRT) increases quit rates and is increasingly distributed through quitlines, but no systematic data are available on adverse effects and safety among quitline NRT users.

Methods: Smokers who contacted the New York State Smokers’ Quitline and were sent free NRT were followed by phone at 2 weeks (n = 33,690), and a randomly selected subsample was followed at 3 months (n = 1,187). All were asked about their use of NRT and adverse effects. Prevalence and perceived severity (rated mild, moderate, or severe) of selected adverse side effects were assessed. Subjects also were asked about their smoking behavior while using NRT and reasons for discontinuation of NRT.

Results: Among those who reported having used NRT at the 2-week contact, about one in four reported an adverse effect. This rate increased to about 42% among those surveyed at 3 months. The prevalence and specific types of adverse effects reported were consistent with findings from clinical trials of NRT and varied in relationship to the type of NRT used (patch, gum, lozenge). The majority of adverse effects reported were rated as mild, and only 4.4%–5.4% of subjects (across the 2-week and 3-month follow-ups) reported discontinuation of NRT as a result of adverse effects.

Discussion: The prevalence and types of adverse effects observed among smokers receiving NRT were as expected with product labeling and support the conclusion that the distribution of over-the-counter NRT through quitlines is safe as long as clients are screened adequately per the labeling instructions.

Received: March 31, 2008; Accepted: September 25, 2008
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