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FDA Notice: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics) - Black Box warning
  Audience: Neuropsychiatric healthcare professionals, patients FDA notified healthcare professionals and patients that it has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products.These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.The added warnings are based on the continued review of postmarketing adverse event reports for varenicline and bupropion received by the FDA. These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease.
Healthcare professionals should advise patients to stop taking varenicline or bupropion and contact a healthcare provider immediately if they experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior.
Public Health Advisory: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban
7/1/2009 The FDA is notifying the public that the use of Chantix (varenicline) or Zyban (bupropion hydrochloride), two prescription medicines that are used as part of smoking cessation programs, has 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 (bupropion), to add a new Boxed Warningto 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, feeling anxious and trouble sleeping.
Smoking is known to cause serious and potentially fatal health consequences, including lung cancer and other cancers, heart attacks, stroke, emphysema, and other breathing/lung diseases. The risks that are known to be associated with smoking must be balanced against the small, but real risk of serious adverse effects associated with medicines that can help patients quit smoking when making the decision on whether to use a medicine and/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 for these products. The Medication Guides are required to be provided to all patients prescribed Chantix, Zyban or generic versions of Zyban for smoking cessation.
The FDA urges health care professionals and patients to report adverse reactions that may be related to the use of Chantix or Zyban to the FDA through the MedWatch program using the information at the bottom of the page. You can find more details about Chantix and Zyban in FDA?s Information for Healthcare Professionals
- Related Information
Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)
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