FDA Gives Nod to Longer Use of Nicotine Patch, Gum
MONDAY, April 1 -- Smokers who are trying to quit can use over-the-counter nicotine replacement gums, lozenges and skin patches for a longer period of time than previously recommended, the U.S. Food and Drug Administration announced Monday.
Any nicotine-containing product is potentially addictive, but decades of research and use have shown that these products do not carry a high risk for abuse or dependence, according to the agency.
Certain other warnings and limitations that were listed on the products' labels are also no longer necessary, the FDA said. This includes a warning that people should not use a nicotine replacement product if they are still smoking, chewing tobacco, using snuff or any other product that contains nicotine, including another nicotine replacement product.
"The agency heard from several public health groups that the labeling for [these] products may stop consumers who are trying to quit smoking from using them," FDA Commissioner Dr. Margaret Hamburg, said in an agency news release. "FDA hopes the recommended changes will allow more people to use these products effectively for smoking cessation and that tobacco dependence will decline in this country."
Nicotine replacement products are FDA-approved for smokers aged 18 and older who want to quit smoking. The products supply controlled amounts of nicotine to help ease withdrawal symptoms as people try to quit smoking.
When nicotine replacement products were first introduced nearly 30 years ago, there wasn't much available data on how long people could safely use them, and whether they could be used in combination with other nicotine replacement products or while people kept smoking, the FDA noted.
While it's safe to use the products longer than the label recommendation in most cases, the agency still advises people to discuss that with their health care providers.
About 70 percent of smokers want to stop smoking, and nearly half of all smokers try to quit each year, according to the FDA news release.
Tobacco use is the leading preventable cause of death in the United States, responsible for more than 440,000 deaths annually. Smoking-related conditions such as cancer, stroke, and heart and lung disease shorten a smoker's life span by an average 14 years, the FDA noted.
The American Cancer Society offers a guide to quitting smoking.
Posted: April 2013