Longer use of nicotine gum approved

Posted: April 03, 2013

RICHMOND, Va. - The Food and Drug Administration says smokers who are trying to quit can safely use over-the-counter nicotine gum, patches, and lozenges for longer than previously recommended, in a move to help millions of Americans kick the habit.

Current labels suggest that consumers stop smoking or using other products containing nicotine when they begin using the products to help them quit, and that they should stop using nicotine replacement products after 12 weeks at most.

The federal agency said Monday that the makers of gum and other nicotine replacement products can change the labels that say one should not smoke when using the products. The FDA also said the companies can let consumers know that they can use the products for longer periods as part of a plan to quit smoking, as long as they are talking to their doctor.

GlaxoSmithKline P.L.C., the leading seller of nicotine-replacement therapy products under the Nicorette and NicoDerm CQ brands, called the FDA's action a "positive step to help more smokers quit." It plans to work with the FDA to make changes to its product labeling "as soon as possible."

Nicotine replacement products, designed to help people stop smoking by supplying controlled amounts of nicotine to ease withdrawal symptoms, were first approved about 30 years ago and have gone from prescription to over-the-counter within the last 17 years. However, when they were approved for over-the-counter use, little reliable data existed on the safety of long-term use or use of more than one product containing nicotine, the FDA said.

In recent years, the agency said, a number of stakeholders in public health have suggested the current labels were barriers for smokers who are trying to quit because they'd relapse if they stopped using the nicotine-replacement products after the suggested time period, and they'd abandon their attempt to quit if they had a cigarette while using them.

More than 45 million Americans smoke cigarettes, and about half try to quit every year, according to the Centers for Disease Control and Prevention.

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