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Addict Behav. 2011 Apr;36(4):327-32. doi: 10.1016/j.addbeh.2010.12.003. Epub 2010 Dec 10.

Cautions and warnings on the US OTC label for nicotine replacement: what's a doctor to do?

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  • 1Pinney Associates, Inc., Bethesda, MD 20814, USA. lzapawa@pinneyassociates.com

Abstract

BACKGROUND:

FDA-approved labeling for over-the-counter (OTC) nicotine replacement therapy (NRT) limits duration of use to a relatively short period of time (10-12 weeks) and explicitly advises against NRT use while smoking or with additional forms of NRT.

OBJECTIVE:

To consider and summarize evidence accumulated since the OTC label was created regarding the safety and efficacy of longer-term and concomitant use to provide recommendations regarding these uses.

METHOD:

Literature searches were conducted on Medline, journal websites, and Internet search engines, with findings reviewed by six smoking cessation researchers.

RESULTS:

Persistent (i.e., long-term) use of NRT does not appear harmful and self-selected persistent use is primarily driven by concerns about relapse to smoking, not addiction. Similarly, continued use of NRT and tobacco during a lapse or relapse and combination NRT treatment do not appear harmful and appear to enhance efficacy.

CONCLUSIONS:

Persistent users of NRT should be counseled to reduce and stop NRT only when they are not concerned about relapsing to smoking. Use of NRT with return to smoking during a lapse or relapse should not be automatically discontinued. Combination NRT therapy should be considered for all smokers, especially those who are unable to quit smoking using a single form of NRT.

Copyright © 2010 Elsevier Ltd. All rights reserved.

PMID:
21220188
[PubMed - indexed for MEDLINE]
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