Medical News and Perspectives
December 15, 2010

FDA Considering Data on Long-term Use of Nicotine Replacement Therapy Products

JAMA. 2010;304(23):2580. doi:10.1001/jama.2010.1804

Short-term nicotine replacement therapy (NRT) has helped many smokers to quit, but many continue to use nicotine replacement products for longer than the recommended 12 to 14 weeks of treatment as they struggle to remain abstinent. But there are limited data on the safety and efficacy of such long-term use, creating a challenge for policy makers such as the US Food and Drug Administration (FDA).

Currently, the FDA has approved the use of NRT products for short-term use only. To begin assessing the data on long-term NRT use and the need for such an indication, the agency convened a workshop on October 27.

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