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Nicotine replacement: safe, even if you still smoke, says FDA

April 01, 2013|By Melissa Healy
  • Good news for quitters: the FDA has announced that using nicotine-replacement products, such as the patch shown off here, is not dangerous even if you slip up and smoke a cigarette.
Good news for quitters: the FDA has announced that using nicotine-replacement… (Geraldine Wilkins DKasinga )

Millions have worn the nicotine patch, chewed the gum or sucked on the lozenge as a way to wean themselves off cigarettes. But millions more have ripped off the patch or spit out the gum or lozenges because they slipped and smoked a cigarette, and believed the warning labels that suggested the combination was dangerous.

Don't worry, the Food & Drug Administration said Monday. Keep using the patch, gum or lozenges and keep trying to quit, even if you're still smoking: there's no danger to using both, at least for a short period.

The new directions to quitters amend warning labels that nicotine-replacement therapies have carried on their labels since they were first introduced to the U.S. market almost three decades ago. Those labels cautioned consumers not to use nicotine-replacement products if they continued to smoke or chew tobacco, and urged them to stop smoking or chewing tobacco completely once they began to use the nicotine replacement product.

Those warnings, the FDA said Monday, aren't necessary anymore in light of new data on nicotine-replacement therapy's safety. Smokers who slip up and smoke while wearing the patch or chewing the gum shouldn't discontinue their use of nicotine-replacement therapy -- a move that could derail their efforts to quit, said the FDA. They should continue to use them and keep trying to quit.

The same relaxed safety warnings apply to the common practice of using two nicotine-replacement products at the same time: those who feel they need to supplement the willpower that comes in the patch with some nicotine gum can do so safely, said the FDA.

While nicotine-replacement products do not have substantial potential for abuse or dependence, the FDA recommends that consumers not use them for longer than the packaging instructions suggest -- generally between eight and 12 weeks. "If they feel they need to continue using the product for longer in order to quit, it is generally safe to do so," said the FDA in a statement released Monday.

GlaxoSmithKlineConsumer Healthcare, which makes Nicorette gum and the NicoDerm CQ patch, called the FDA's label change "a positive step to help more smokers quit," and noted that nicotine-replacement products' safety and effectiveness in helping smokers quit have been demonstrated in 110 clinical trials involving more than 40,000 participants.

About one in five American adults -- about 46 million people -- continues to smoke. In any given year, almost half of those try to quit.

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