Label Changes for:

Chantix (varenicline) 0.5 mg and 1 mg tablets

July 2009

Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009

BOXED WARNING

  • Serious neuropsychiatric events, including, but not limited to depression, suicidal ideation, suicide attempt and completed suicide have been reported in patients taking Chantix...

WARNINGS

Neuropsychiatric Symptoms and Suicidality
  • Serious neuropsychiatric symptoms have been reported in patients being treated with Chantix.  These post-marketing reports have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide...
  • Advise patients and caregivers that the patient should stop taking CHANTIX and contact a health care provider immediately if agitation, depressed mood, changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of symptoms after discontinuation of CHANTIX was reported although in some cases the symptoms persisted, therefore, ongoing monitoring and supportive care should be provided until symptoms resolve...

PRECAUTIONS

General: Accidental Injuries

There have been post-marketing reports of traffic accidents, near-miss incidents in traffic, or other accidental injuries in patients taking Chantix...

General: Angioedema and Hypersensitivity Reactions
Information for Patients

ADVERSE REACTIONS

Post-Marketing Experience
  • There have been reports of depression, mania, psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide in patients attempting to quit smoking while taking Chantix.

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