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GlaxoSmithKline Consumer Healthcare Response to New York Times Article About Long-Term Use of Nicorette®

May 3, 2004

Nicotine gum has safely and effectively helped millions of people quit over the last 20 years, but a story in the May 2, 2004 business section of The New York Times may have left readers with an incorrect perception that a large number of Nicorette® gum users continue their therapy far beyond the recommended 12-week period1.

Nicotine replacement therapy (NRT) products offer a step-down therapy that doubles a smoker’s chances of quitting versus cold turkey. Nicorette gum also offers a comprehensive support program called Committed Quitters®, which has been clinically proven to increase chances of quitting when used in conjunction with NRT.

Some key facts:

  • Over 100 clinical trials involving more than 35,000 patients and extensive use for 20 years have proven the safety and efficacy of NRT products when used as directed.2
  • Use beyond the 12-week treatment regimen approved by the U.S. Food & Drug Administration (FDA) is contrary to labeling. GlaxoSmithKline (GSK) Consumer Healthcare advises users to follow the directions on Nicorette labeling which state, “stop using the nicotine gum at the end of 12 weeks.” 3
  • In a recent study of how long quitters used Nicorette, almost 89% stopped use within the recommended time; only 7% used the gum for 6 months or more, and this dropped to 1% or less by 24 months.4 Persistent use of nicotine gum is rare and has not increased with the transition to over-the-counter use, despite removal of physician supervision.4
  • According to the smoking cessation guidelines from the U.S. Public Health Service, some smokers may need NRT treatment for longer than 3 months; quitters who feel they may need longer treatment should talk to their doctor.5
  • NRT has helped millions of people around the world quit smoking and, as a result, has significantly reduced their exposure to the risks of cancer and other smoking-related diseases.6

GSK Consumer Healthcare welcomes any additional research that helps us understand more about the workings of treatments such as NRT.

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and consumer healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

1. Bartosiewicz, P, A Quitter’s Dilemma: Hooked on the Cure, The New York Times. 2004 May 2, Business Section, page 8. 2. GlaxoSmithKline Consumer Healthcare, LP, data on file.
3. Nicorette product packaging/Nicorette patient information.
4. Shiffman, S; Hughes, JR; Pillitteri, JL; Burton, SL. Persistent use of nicotine replacement therapy:
an analysis of actual purchase patterns in a population-based sample. Tobacco Control. 2003 Sep;12(3):310-6.
5. Fiore, MC; Bailey, WC; Cohen, SJ; et al. Treating tobacco use and dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. June 2000; 79.
6. Shiffman S; Gitchell J; Pinney J; Burton SL; Kemper KE; Lara EA. Public health impact of over-the-counter nicotine medications. Tobacco Control 1997; 6:306-310.

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