Boxed warning required for Chantix and Zyban, says FDA

by Anil Kumar

Know more about
Smoking
Boxed warning required for Chantix and Zyban, says FDA

Smoking cessation drugs Chantix and Zyban are causing unusual changes in behavior, depression, and suicidal thinking in those who have taken these drugs to quit their smoking habits.

The U.S. Food and Drug Administration is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion).

The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

"The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking," said Janet Woodcock, M.D., director, the FDA's Center for Drug Evaluation and Research. "Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit."

Similar information on mental health events will be required for bupropion marketed as the antidepressant Wellbutrin and for generic versions of bupropion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

It is advised that health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs.

Patients should immediately contact their health care professional if they experience such changes.

Chantix is manufactured by New York based Pfizer Inc. Zyban is manufactured by GlaxoSmithKline, Brentford, Middlesex, United Kingdom.


(Anil Kumar -- sub-editor compiled and published Boxed warning required for Chantix and Zyban, says FDA at HealthNewsTrack on July 1, 2009 sourced from U.S. Food and Drug Administration - http://www.fda.gov/)

Smoking - recent articles and current news stories:

- Nicotine patches and nicotine gum not effective in helping smokers quit long term
- Smoking causes stroke to occur 10 years before
- Stopping smoking boosts everyday memory
- Cigarette smoking implicated in half of bladder cancers in women
- Chantix increases risk of heart attack or arrhythmia

Smoking article/news source:

Read more health articles from U.S. Food and Drug Administration and health articles from USA.

Smoking - search related terms:

Behavior, Boxed warning, Bupropion, Chantix, Depressed mood, Depression, Smoking, Smoking cessation, Varenicline, Zyban,
Smoking books,

Mission
Health Newstrack is dedicated to serve recent and updated health & medical research, events/news, views/reviews to its subscribers and free access to general public, health & medical professionals, and other health seekers worldwide online with a user-friendly system.


Subscribe to Health News by Email

Current news
FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

Smoking
About Smoking
Smoking is the inhalation of the smoke of burning tobacco encased in cigarettes, pipes, and cigars. Casual smoking is the act of smoking only occasionally, usually in a social situation or to relieve stress. A smoking habit is a physical addiction to tobacco products. Many health experts now regard habitual smoking as a psychological addiction, too, and one with serious health consequences.


List health news, Health organizations, Health news world, Glossary, Best health articles, Featured     Go to top

The information provided on Health Newstrack is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician. We comply with the HONcode principles for trustworthy health information, and Health News Track is hon code accredited, verify here.
About us, Site map Privacy policy, Disclaimer
© 2007, 2008, 2009, 2010, 2011 HealthNewsTrack.com
1.86