Varenicline (marketed as Chantix) Information
FDA ALERT [2/1/2008]
:
FDA is issuing this Alert to highlight important revisions to the
WARNINGS and PRECAUTIONS sections of the full prescribing information
for Chantix regarding serious neuropsychiatric symptoms. Serious
neuropsychiatric symptoms have occurred in patients taking Chantix.
These symptoms include changes in behavior, agitation, depressed mood,
suicidal ideation, and attempted and completed suicide. While some
patients may have experienced these types of symptoms and events as a
result of nicotine withdrawal, some patients taking Chantix who
experienced serious neuropsychiatric symptoms and events had not yet
discontinued smoking. In most cases, neuropsychiatric symptoms
developed during Chantix treatment, but in others, symptoms developed
following withdrawal of Chantix therapy.
FDA first informed the public about the possibility of serious neuropsychiatric symptoms in the November 20, 2007 FDA Early Communication About an Ongoing Safety Review.
At that time, information about serious neuropsychiatric symptoms in
patients taking Chantix was added to the POST-MARKETING EXPERIENCE
section of the prescribing information. As FDA’s review of the issue
has progressed, it appears increasingly likely that there is an
association between Chantix and serious neuropsychiatric symptoms. As a
result, FDA requested that Pfizer, the manufacturer of Chantix, elevate
the prominence of this safety information to the WARNINGS and
PRECAUTIONS sections of the Chantix prescribing information. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients.
[5/16/2008]: The issues described in this communication have been addressed in the product labeling and FDA has approved the Medication Guide.
If either you, your family or caregiver notice agitation, depressed
mood, or changes in behavior that are not typical for you, or if you
have suicidal thoughts or actions, stop taking Chantix and call your
doctor right away.
This
information reflects FDA's current analysis of data available
concerning this drug. FDA is not advising practitiones to discontinue
prescribing the product and intends to provide updated information when
it becomes available.
To
report any unexpected adverse or serious events associated with the use
of this drug, please contact the FDA MedWatch program and complete a
form on line at http://www.fda.gov/medwatch/report/hcp.htm
or report by fax to 1-800-FDA-0178, by mail using the postage-paid
address form provided on line, or by telephone to 1-800-FDA-1088.
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Healthcare Professional Information
Date created: February 1, 2008; updated May 16, 2008
(5/16/2008)