Nicotine Substitutes / Nicotine Replacement Therapy

AHA Recommendation and Advocacy Position

The American Heart Association believes that nicotine transdermal patches and other nicotine substitution drug products, such as nicotine gum, can help smokers quit when used as part of a comprehensive smoking cessation program. There are public safety issues concerning the patches — including indications, contraindications, warnings and precautions, and issues such as effectiveness, potential abuse and advertising and marketing. These are appropriately regulated by the U.S. Food and Drug Administration (FDA). The American Heart Association will continue to review the science concerning the use of nicotine patches and other nicotine substitution products and to make comments to the FDA when appropriate.

Nicotine replacement therapy (NRT) has been shown to be safe and effective in helping people stop using cigarettes when used as part of a comprehensive smoking cessation program. NRT medicines are available as gum and patches over-the-counter. They can be used by people outside formal stop-smoking programs, but they're less effective when used that way. NRT is also available by prescription as a nasal spray and as a puffer ("inhaler").

The consistent use of one of these products doubles a person's chances of quitting smoking. However, NRT does not "make" you stop smoking. Behavior change and support are essential. A smoking cessation program can take many forms, including self-help booklets and telephone counseling. In general, the more intense the behavior modification therapy, the greater the chance of success.

The American Heart Association commends the FDA for approving a variety of medicines to treat tobacco dependence and for determining that cigarettes and smokeless tobacco products are drugs and devices under the Food, Drug and Cosmetic Act. The association strongly supports the agency's efforts to defend its jurisdictional determination in court. We also support Congressional efforts to give the FDA full authority to regulate all tobacco products and medicines to treat tobacco dependence in parallel, using what the agency does with one class of products to inform what it does with the other.

How do nicotine replacement products help?

Nicotine is the addictive substance in tobacco products. NRT provides nicotine in a safe form so the body doesn't have to endure nicotine withdrawal while a person adapts to not smoking. Trying to learn skills to help in quitting smoking while dealing with nicotine withdrawal makes it harder to successfully quit.

Nicotine withdrawal symptoms include irritability, difficulty concentrating, feelings of depression, difficulty sleeping, increased appetite cravings and headache. These symptoms often start just a few hours after the last cigarette. The first 72 hours of quitting are the hardest, but symptoms may persist for weeks. Smokers have learned that a cigarette will relieve these symptoms in a few moments. But taking nicotine in another form can suppress withdrawal.

NRT products only provide nicotine. They contain none of the carcinogens or toxic gases found in cigarette smoke.

How do I use NRT?

  • Follow the advice of a general practitioner, nurse or pharmacist.
  • Decide which type of NRT best suits you.
  • Set a start date. Stop smoking and start NRT right away.
  • You should use NRT regularly at first, not “every now and then.”
  • Use NRT for at least eight to 12 weeks to have the best chance of stopping smoking.
  • The dose of NRT is typically reduced during the later stages of treatment, then stopped altogether.
  • Some experts advise using combinations of NRT medicines for some people. For example, a person might use a patch for baseline comfort supplemented by the gum or the inhaler to suppress urges as they arise.

NRT may not be suitable if you're pregnant or have heart disease:

  • Pregnancy: while the use of replacement products during pregnancy is not risk-free, it's much less dangerous to you and your baby than smoking. If you're pregnant or planning to become pregnant and want to stop smoking, talk to your healthcare professional before deciding on a course of action. Most professionals will recommend trying other ways to change your behavior before suggesting a nicotine replacement product.
  • Heart disease: NRT has been shown to be safe in most people with heart disease. However, if you've recently had heart problems, such as an irregular or rapid heartbeat, or chest pain, consult your doctor before using nicotine replacement products.

Side effects

All forms of nicotine replacement have side effects. Many of them become easier to tolerate over time. In a recent article, the Institute for Safe Medication Practices addresses another hazard that many people may not know about — transdermal medication patches, like those that deliver nicotine, can cause burns if a patient wears them during an MRI procedure. Tell your doctor that you use a medication patch if you're going to undergo an MRI.  

What about smoking while using NRT?

It's not unusual for people trying to stop smoking using NRT to still give in to an occasional cigarette. Most successful quitters have two to three relapses before they quit smoking for life. (A relapse is a return to the behavior you are trying to eliminate.)

Combining the nicotine from the NRT with the nicotine from cigarettes is a concern. If someone is smoking only a few cigarettes while trying to quit, it makes sense to continue the NRT and resolve how to avoid each of the last few remaining cigarettes. But if the person is smoking as much (or nearly as much) on NRT as off of it, they should stop the NRT and prepare better before trying to quit smoking again.

What about withdrawal from NRT?

Most of the time people who use NRT to stop smoking gradually reduce or stop NRT medicine as prescribed without any difficulty. Some people keep using the gum, nasal spray or inhaler for a long time. Using NRT is always preferable to using tobacco products. If the choice is between an NRT product and a tobacco product, the person should keep using NRT. If a person feels that gradually stopping NRT is very hard, he or she should speak with a doctor.

If you have questions about NRT products, call the manufacturer's toll-free 800 number (printed on the package label) or speak with a doctor or pharmacist.

AHA Scientific Statements:


See also:

Tobacco, Federal Regulation of
Office on Smoking and Health
Smoking Cessation
Smoking Cessation Guidelines

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