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: Police seize millions in huge fake Viagra swoop

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

Mirabegron for overactive bladder: Added benefit not proven

9 hours ago

Mirabegron (trade name: Betmiga) has been approved since December 2012 for the treatment of adults with overactive bladder. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products ...

Novartis Japan admits concealing drug side effects

Sep 01, 2014

The Japanese unit of Swiss pharma giant Novartis has admitted it did not report more than 2,500 cases of serious side effects in patients using its leukaemia and other cancer drugs, reportedly including some fatalities.

Most US babies get their vaccines, CDC says

Aug 28, 2014

(HealthDay)—The vast majority of American babies are getting the vaccines they need to protect them from serious illnesses, federal health officials said Thursday.

User comments : 0