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

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.