Extended Use of Nicotine Replacement Products to Help Quit Smoking Approved by FDA

First Posted: Apr 01, 2013 02:53 PM EDT
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According to a new report from the Food and Drug Administration, smokers who are trying to give up smoking with over-the-counter nicotine gum, patches and lozenges for longer than previously recommended, though the labels may suggest otherwise. 

Health researchers now believe it is safe to extend the use of such products despite messages stating that products containing nicotine should not be extended over a 12-week period.  

The FDA said that the makers of gum and other nicotine replacement products can also now change the labels that say not to smoke when using the products.

Nicotine replacement products, designed to help people stop smoking by supplying controlled amounts of nicotine to ease the withdrawal symptoms, were first approved about 30 years ago and have since 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, according to the FDA.

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

Smoking is the leading cause of preventable illness and death in the U.S. and is responsible for the majority of the nation's lung cancer deaths. It's also a factor in heart attacks and a variety of illnesses.

The agency hopes the recommended changes will "allow more people to use these products effectively for smoking cessation and that tobacco dependence will decline," FDA Commissioner Margaret Hamburg said in a statement, according to USA Today

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