New Safety Warnings for Chantix

FDA issued a Public Health Advisory on Feb. 1, 2008, to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline). Chantix is a prescription medication used to help people stop smoking.

Chantix was approved by FDA in May 2006. In November 2007, FDA issued an Early Communication to tell the public and health care providers that the agency was evaluating adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal thoughts, and attempted and completed suicide.

As FDA continues its review of the adverse event reports, it appears increasingly likely that there may be an association between Chantix and serious mood and behavior symptoms.

FDA has requested that Pfizer, the manufacturer of Chantix, give the safety information a more prominent position on the drug's prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients.

"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,” says Bob Rappaport, M.D., Director of FDA’s Division of Anesthesia, Analgesia and Rheumatology Products. "Patients should talk with their doctors about this new information and whether Chantix is the right drug for them."

Tips for Consumers
* Tell your health care provider about any history of psychiatric illness before you start taking Chantix.
* Immediately tell a doctor if you or someone you care for has any changes in mood and behavior while being treated with Chantix. In most cases, mood and behavior changes developed during treatment, but some people developed symptoms after they stopped taking Chantix.
* Be aware that vivid, unusual, or strange dreams may occur while taking Chantix.
* Chantix may affect your ability to drive or operate machinery.

For More Information

FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01788.html