FDA: New warning needed for Chantix

February 3, 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: Safety, effectiveness of e-cigarettes unknown

Related Stories

Safety, effectiveness of e-cigarettes unknown

February 8, 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 smokers cut down ...

FDA requires Chantix, Zyban to have warning

July 1, 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

How the finch changes its tune

August 3, 2015

Like top musicians, songbirds train from a young age to weed out errors and trim variability from their songs, ultimately becoming consistent and reliable performers. But as with human musicians, even the best are not machines. ...

Machine Translates Thoughts into Speech in Real Time

December 21, 2009

(PhysOrg.com) -- By implanting an electrode into the brain of a person with locked-in syndrome, scientists have demonstrated how to wirelessly transmit neural signals to a speech synthesizer. The "thought-to-speech" process ...

0 comments

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.