Addressing the evidence for FDA nicotine replacement therapy label changes: A policy statement of the association for the treatment of tobacco use and dependence and the society for research on nicotine and tobacco

Lisa M. Fucito, Matthew P. Bars, Ariadna Forray, Alana M. Rojewski, Saul Shiffman, Peter Selby, Robert West, Jonathan Foulds, Benjamin A. Toll

Research output: Contribution to journalComment/debate

18 Citations (Scopus)

Abstract

Cigarette smoking creates a substantial public health burden. Identifying new, effective smoking cessation interventions that optimize existing interventions and promoting effective use of approved medications is a priority. When used as directed, nicotine replacement therapy (NRT) aids smoking cessation, but there is opportunity for improving its effectiveness. Until recently, NRT use guidelines advised smokers to begin using NRT on their quit date, only to use 1 NRT formulation at a time, to refrain from using NRT while smoking, and to stop NRT within 3 months regardless of progress. The Food and Drug Administration (FDA) issued a recent announcement allowing for NRT labeling changes with applications from pharmaceutical companies for such changes, and we applaud this decision. Nevertheless, additional revisions are warranted by current research. There is robust evidence that combining a longer-acting form (e.g., patch) with a shorter-acting form (e.g., lozenge) is more effective than NRT monotherapy and is safe. Moreover, extant evidence suggests that NRT use prior to a quit attempt or for smoking reduction as part of a quit attempt is safe and as effective as starting NRT on quit date. Specifically, prequit nicotine patch increases quit rates and may engage additional recalcitrant smokers. Last, NRT use longer than 3 months is safe and may be beneficial for relapse prevention in some smokers. This report summarizes the FDA announcement, reviews the evidence for further revisions to current FDA NRT guidelines, and makes recommendations for over-the-counter (OTC) NRT labeling to allow for (1) combined use of faster-acting NRT medications with nicotine patch, (2) nicotine patch use prior to quit date or NRT for smoking reduction as part of a quit attempt, and (3) prolonged NRT for up to 6 months without healthcare provider consultation.

Original languageEnglish (US)
Article numberntu087
Pages (from-to)909-914
Number of pages6
JournalNicotine and Tobacco Research
Volume16
Issue number7
DOIs
StatePublished - Jan 1 2014

Fingerprint

Tobacco Use Disorder
Tobacco Use
United States Food and Drug Administration
Nicotine
Tobacco
Research
Therapeutics
Tobacco Use Cessation Products
Smoking
Smoking Cessation
Guidelines
Secondary Prevention

All Science Journal Classification (ASJC) codes

  • Public Health, Environmental and Occupational Health

Cite this

Fucito, Lisa M. ; Bars, Matthew P. ; Forray, Ariadna ; Rojewski, Alana M. ; Shiffman, Saul ; Selby, Peter ; West, Robert ; Foulds, Jonathan ; Toll, Benjamin A. / Addressing the evidence for FDA nicotine replacement therapy label changes : A policy statement of the association for the treatment of tobacco use and dependence and the society for research on nicotine and tobacco. In: Nicotine and Tobacco Research. 2014 ; Vol. 16, No. 7. pp. 909-914.
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abstract = "Cigarette smoking creates a substantial public health burden. Identifying new, effective smoking cessation interventions that optimize existing interventions and promoting effective use of approved medications is a priority. When used as directed, nicotine replacement therapy (NRT) aids smoking cessation, but there is opportunity for improving its effectiveness. Until recently, NRT use guidelines advised smokers to begin using NRT on their quit date, only to use 1 NRT formulation at a time, to refrain from using NRT while smoking, and to stop NRT within 3 months regardless of progress. The Food and Drug Administration (FDA) issued a recent announcement allowing for NRT labeling changes with applications from pharmaceutical companies for such changes, and we applaud this decision. Nevertheless, additional revisions are warranted by current research. There is robust evidence that combining a longer-acting form (e.g., patch) with a shorter-acting form (e.g., lozenge) is more effective than NRT monotherapy and is safe. Moreover, extant evidence suggests that NRT use prior to a quit attempt or for smoking reduction as part of a quit attempt is safe and as effective as starting NRT on quit date. Specifically, prequit nicotine patch increases quit rates and may engage additional recalcitrant smokers. Last, NRT use longer than 3 months is safe and may be beneficial for relapse prevention in some smokers. This report summarizes the FDA announcement, reviews the evidence for further revisions to current FDA NRT guidelines, and makes recommendations for over-the-counter (OTC) NRT labeling to allow for (1) combined use of faster-acting NRT medications with nicotine patch, (2) nicotine patch use prior to quit date or NRT for smoking reduction as part of a quit attempt, and (3) prolonged NRT for up to 6 months without healthcare provider consultation.",
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Addressing the evidence for FDA nicotine replacement therapy label changes : A policy statement of the association for the treatment of tobacco use and dependence and the society for research on nicotine and tobacco. / Fucito, Lisa M.; Bars, Matthew P.; Forray, Ariadna; Rojewski, Alana M.; Shiffman, Saul; Selby, Peter; West, Robert; Foulds, Jonathan; Toll, Benjamin A.

In: Nicotine and Tobacco Research, Vol. 16, No. 7, ntu087, 01.01.2014, p. 909-914.

Research output: Contribution to journalComment/debate

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T2 - A policy statement of the association for the treatment of tobacco use and dependence and the society for research on nicotine and tobacco

AU - Fucito, Lisa M.

AU - Bars, Matthew P.

AU - Forray, Ariadna

AU - Rojewski, Alana M.

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AU - Selby, Peter

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AU - Foulds, Jonathan

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AB - Cigarette smoking creates a substantial public health burden. Identifying new, effective smoking cessation interventions that optimize existing interventions and promoting effective use of approved medications is a priority. When used as directed, nicotine replacement therapy (NRT) aids smoking cessation, but there is opportunity for improving its effectiveness. Until recently, NRT use guidelines advised smokers to begin using NRT on their quit date, only to use 1 NRT formulation at a time, to refrain from using NRT while smoking, and to stop NRT within 3 months regardless of progress. The Food and Drug Administration (FDA) issued a recent announcement allowing for NRT labeling changes with applications from pharmaceutical companies for such changes, and we applaud this decision. Nevertheless, additional revisions are warranted by current research. There is robust evidence that combining a longer-acting form (e.g., patch) with a shorter-acting form (e.g., lozenge) is more effective than NRT monotherapy and is safe. Moreover, extant evidence suggests that NRT use prior to a quit attempt or for smoking reduction as part of a quit attempt is safe and as effective as starting NRT on quit date. Specifically, prequit nicotine patch increases quit rates and may engage additional recalcitrant smokers. Last, NRT use longer than 3 months is safe and may be beneficial for relapse prevention in some smokers. This report summarizes the FDA announcement, reviews the evidence for further revisions to current FDA NRT guidelines, and makes recommendations for over-the-counter (OTC) NRT labeling to allow for (1) combined use of faster-acting NRT medications with nicotine patch, (2) nicotine patch use prior to quit date or NRT for smoking reduction as part of a quit attempt, and (3) prolonged NRT for up to 6 months without healthcare provider consultation.

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