FDA: New warning needed for Chantix

Feb 03, 2008

The U.S. Food and Drug Administration Friday called for increased awareness of the health risks of the smoking cessation drug varenicline.

The agency said it appears increasingly likely that there may be an association between the drug, marketed by Pfizer under the name Chantix, and serious neuropsychiatric symptoms including agitation, depression, suicidal thoughts and actual suicidal behavior.

The FDA has requested that Pfizer elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information.

"Chantix has proven to be effective in smokers motivated to quit, but patients and healthcare professionals need the latest safety information to make an informed decision regarding whether or not to use this product," the FDA's Dr. Bob Rappaport said in a release. "While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks.

Chantix was approved by FDA in May 2006 as a smoking cessation drug.

Copyright 2008 by United Press International

Explore further: FDA approves ADHD drug for binge-eating disorder

add to favorites email to friend print save as pdf

Related Stories

Safety, effectiveness of e-cigarettes unknown

Feb 08, 2011

Electronic cigarettes are drawing heavy media and marketing attention, and while a new study finds that consumer interest also runs high, a companion study underscores that e-cigarettes’ ability to help ...

FDA requires Chantix, Zyban to have warning

Jul 01, 2009

(AP) -- The Food and Drug Administration will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency's strongest safety warning over side effects including depression and suicidal thoughts.

Recommended for you

Generic form of nexium approved

Jan 26, 2015

(HealthDay)—The first generic version of the heartburn drug Nexium (esomeprazole) has been approved by the U.S. Food and Drug Administration.

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.