FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban

On July 1, 2009, the Food and Drug Administration issued a public health advisory titled: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban.

I am Pat Clarke from F-D-A’s Center for Drug Evaluation and Research.

The FDA is notifying the public that the use of Chantix, also known as Varenicline, or Zyban, also known as Bupropion Hydrochloride, two prescription medicines that are used as part of smoking cessation programs, have been associated with reports of changes in behavior such as hostility, agitation, depressed mood, and suicidal thoughts or actions.  The FDA is requiring the manufacturers of these products, including generic versions of Zyban, to add a new Boxed Warning to the product labeling to alert healthcare professionals to this important new safety information.

People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their healthcare professional right away.

Friends or family members who notice these changes in behavior in someone who is taking Chantix or Zyban for smoking cessation should tell the person their concerns and recommend that he or she stop taking the drug and call a healthcare professional right away.

Although Chantix and Zyban are effective aids in helping people stop smoking, they have been associated with serious adverse effects. Some people who have taken Chantix or Zyban to help them quit smoking have reported experiencing unusual behavior changes, have become depressed or have had their depression worsen, or have had thoughts about suicide or dying; some have attempted suicide either while using one of these drugs or after they stopped taking them. 

Since Chantix and Zyban do not contain nicotine, people who decide to use these drugs to help them stop smoking may still experience symptoms of nicotine withdrawal.  It is common for people who are attempting to break their nicotine habit to experience unpleasant symptoms like depressed mood, irritability, restlessness, trouble sleeping and feeling anxious.

Smoking is known to cause serious and potentially fatal health consequences, including lung cancer and other cancers, heart attacks, stroke, emphysema, and other breathing or lung diseases.  The risks that are known to be associated with smoking must be balanced against the small, but real risk of serious adverse events associated with medicines that can help patients quit smoking when making the decision on whether to use a medicine or other method to help stop smoking.

In addition to the new Boxed Warning, FDA is also requiring the manufacturers of Chantix, Zyban, and generic versions of Zyban to describe these risks in the Medication Guides, which are required to be provided to all patients using these products.

We urge healthcare providers and patients to report adverse reactions that may be related to the use of Chantix or Zyban, to us at the FDA’s MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot GOV slash M-E-D-W-A-T-C-H.