Neuropsychiatric Symptoms and Suicidality Boxed Warning, PRECAUTIONS/Information for patients, and ADVERSE REACTIONS/Post-Marketing Experience ).
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. Some reported cases may have been
complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may
be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported
in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms
have occurred in patients taking CHANTIX who continued to smoke. When symptoms were reported, most were
during CHANTIX treatment, but some were following discontinuation of CHANTIX therapy.
These events have occurred in patients with and without pre-existing psychiatric disease;
some patients have experienced worsening of their psychiatric illnesses. All patients being
treated with CHANTIX should be observed for neuropsychiatric symptoms or worsening of pre-existing
psychiatric illness. Patients with serious psychiatric illness such as schizophrenia, bipolar
disorder, and major depressive disorder did not participate in the pre-marketing studies of
CHANTIX and the safety and efficacy of CHANTIX in such patients has not been established.
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.
The risks of CHANTIX should be weighed against the benefits of its use. CHANTIX has been
demonstrated to increase the likelihood of abstinence from smoking for as long as one year
compared to treatment with placebo. The health benefits of quitting smoking are immediate and
substantial.
Angioedema and Hypersensitivity Reactions. ADVERSE REACTIONS/Post-Marketing Experience ).
Clinical signs included swelling of the face, mouth (tongue, lips, and gums), extremities,
and neck (throat and larynx). There were infrequent reports of life-threatening angioedema
requiring emergent medical attention due to respiratory compromise. Patients should be instructed
to discontinue CHANTIX and immediately seek medical care if they experience these symptoms.
Serious Skin Reactions ADVERSE REACTIONS/Post-Marketing Experience ) As these skin reactions can be
life-threatening, patients should be instructed to stop taking CHANTIX and contact their
healthcare provider immediately at the first appearance of a skin rash with mucosal
lesions or any other signs of hypersensitivity.