FDA 101: Smoking Cessation Products

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Food and Drug Administration
January 26, 2010

It’s hard to quit smoking, but there are products that can help you quit.  No matter how long you have smoked, stopping can decrease your risk of lung cancer and possibly lower your risk of breast cancer.  Here are some important points to remember:

There are two types of smoking cessation products:

  1. Those that contain nicotine to help you reduce your addiction by lowering the levels
  2. Those that do not contain nicotine that are intended to ease withdrawal symptoms

If you use a nicotine replacement product, only use one kind. Do not use gum and a patch on the same day, for example.  Call your health care professional if you experience nausea, dizziness, weakness, vomiting, fast or irregular heartbeat, mouth problems with the lozenge or gum, or redness or swelling of the skin around the patch that does not go away.

Talk to your health care professional before using these products if you have

  • diabetes, heart disease, asthma, or stomach ulcers
  • had a recent heart attack
  • high blood pressure that is not controlled with medicine
  • a history of irregular heartbeat
  • been prescribed medication to help you quit smoking

Women who are pregnant or breast-feeding should use these products only with approval from their health care professional.

If you take prescription medication for depression or asthma, let your health care professional know if you are quitting smoking; your prescription dose may need to be adjusted.

Products Not Containing Nicotine

Two medicines that do not contain nicotine have FDA’s approval as smoking cessation products. They are Chantix (varenicline tartrate) and Zyban (buproprion). Both are available in tablet form on a prescription-only basis.  Neither of these drugs is recommended for people under 18 years of age.

Both products have serious risks, and can cause changes in behavior, depressed mood, hostility, and suicidal thoughts or actions.

Before taking either of these products, read the product’s patient medication guide in its entirety if you use or plan to use either Chantix or Zyban. These guides offer important warnings that you need to know before making a decision.

Chantix acts at sites in the brain affected by nicotine. It provides some nicotine effects to ease withdrawal symptoms and blocks the effects of nicotine from cigarettes if users resume smoking.

For more information, click here for the FDA article.