title: 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.
  
  
  METHODS
  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.
authors.affiliation: Pinney Associates, Inc., Bethesda, MD 20814, USA. lzapawa@pinneyassociates.com
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Zapawa
authors.forename: John R
authors.initials: JR
authors.lastname: Hughes
authors.forename: Neal L
authors.initials: NL
authors.lastname: Benowitz
authors.forename: Nancy A
authors.initials: NA
authors.lastname: Rigotti
authors.forename: Saul
authors.initials: S
authors.lastname: Shiffman
mesh_terms: D002638:Chewing Gum; D004359:Drug Therapy, Combination; D006801:Humans; D018722:Nicotinic Agonists / Q000008:administration & dosage*; D004366:Nonprescription Drugs / Q000008:administration & dosage*; D012651:Self Medication / Q000009:adverse effects*; D016540:Smoking Cessation / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D002638:Chewing Gum; D018722:Nicotinic Agonists; D004366:Nonprescription Drugs