Adverse effects with use of nicotine replacement therapy among quitline clients.

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.