News Flash

New Boxed Warning Added to Smoking Cessation Aids Varenicline and Bupropion

July 06, 2009

Source: The Food and Drug Administration

The FDA requires new Boxed Warnings on smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics).

The new boxed warnings highlight the risk to patients of serious neuropsychiatric symptoms including:

  • changes in behavior
  • hostility
  • agitation
  • depressed mood
  • suicidal thoughts and behaviors
  • attempted suicide

Health care professionals should advise patients to stop taking varenicline or bupropion and contact a health care provider immediately if they experience any of the possible side effects.

Read the complete MedWatch 2009 Safety Summary, including a link to the FDA News Release, at:
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170090.htm.