[HALEY]

Post-Marketing Experience:
The following adverse events have been reported during post-approval use of Chantix. Because these
events are reported voluntarily from a population of uncertain size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to drug exposure.
There have been reports of depressed mood, agitation, changes in behavior, suicidal ideation and
suicide in patients attempting to quit smoking while taking Chantix. Smoking cessation with or without
treatment is associated with nicotine withdrawal symptoms and the exacerbation of underlying
psychiatric illness. Not all patients had known pre-existing psychiatric illness and not all had
discontinued smoking. The role of Chantix in these reports is not known.