FDA orders additional warnings on Chantix and Zyban labels following reports of serious neuropsychiatric symptoms including suicidal thoughts and behavior, depression, and hostility
On July 1, 2009 the U.S. Food & Drug Administration issued a Public Health Advisory notifying the public that the prescription smoking-cessation drugs Chantix (varenicline) and Zyban (bupropion hydrochloride) have been associated with reports of changes in behavior including suicidal thoughts, depression, and hostility. In response to these reports the FDA has ordered the addition of a boxed warning to the Chantix and Zyban labels to alert healthcare professionals of this new safety information.

According to a study by the Institute for Safe Medicine Practices, from May 2006 through December 2007, the FDA has received 227 domestic reports of suicidal acts, thoughts or behaviors, including 28 cases of suicides; 397 cases of possible psychosis; and 525 reports of hostility or aggression. In response to the study, the Federal Aviation Administration has issued a ban on the use of Chantix by pilots and air traffic controllers.

The FDA advises Chantix and Zyban users to immediately contact a healthcare professional if they experience any serious or unusual changes in mood or behavior or if they feel like hurting themselves or someone else.

If you or a loved one suffered serious side effects or injury following the use of Chantix or Zyban, please contact us for a free and confidential case review.

INFORMATION, ADVISORIES & ALERTS FROM THE FDA

7/1/2009: Public Health Advisory: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban

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 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, 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.

2/1/2008: FDA Issues Public Health Advisory on Chantix
Agency requests that manufacturer add new safety warnings for smoking cessation drug

The U.S. Food and Drug Administration (FDA) today issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking. 

On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.

As the agency's review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients. This is an example of FDA working with drug manufacturers throughout products' lifecycles to keep health care professionals and patients informed of new and emerging safety data.

"Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," said  Bob Rappaport, M.D., director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products. "While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug."

Chantix was approved by FDA in May 2006 as a smoking cessation drug. Chantix acts at sites in the brain affected by nicotine and may help those who wish to stop smoking by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if users resume smoking.

In the Public Health Advisory and a Health Care Professional Sheet that was also issued today, FDA emphasized the following safety information for patients, caregivers, and health care professionals: 

• Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug's approval.
• Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.
• Patients should immediately report changes in mood and behavior to their doctor. 
• Vivid, unusual, or strange dreams may occur while taking Chantix.
• Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

FDA will continue to update health care professionals with new information from FDA's continuing review or if new information is received on Chantix and serious neuropsychiatric symptoms. FDA may consider requesting further revisions to the labeling or taking other regulatory action as the agency's continuing reviews and conclusions warrant.