FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix
and Zyban
The U.S. Food and Drug Administration today announced
that it is requiring manufacturers to put a Boxed Warning on the prescribing
information for the smoking cessation drugs
Chantix (varenicline) and
Zyban
(bupropion). The warning will highlight the risk of serious mental health
events including changes in behavior, depressed mood, hostility, and suicidal thoughts when
taking these drugs.
"The risk of serious adverse events while taking these
products must be weighed against the significant health benefits of quitting
smoking," said Janet Woodcock, M.D., director, the FDA's Center for Drug Evaluation and Research.
"Smoking is the leading cause of preventable disease, disability, and death in
the United States and we know these products are effective aids in helping
people quit."
Similar information on mental health events will be
required for bupropion marketed as the antidepressant
Wellbutrin and for generic versions of
bupropion. These drugs already carry a Boxed Warning for suicidal behavior in
treating psychiatric disorders.
Woodcock said health care professionals who prescribe Chantix and Zyban
should monitor their patients for any unusual changes in mood or behavior after
starting these drugs. She added that patients should immediately contact their
health care professional if they experience such changes.
The FDA's request for the additional warnings is based
on a review of reports submitted to the agency's Adverse Event Reporting System since the time the
products were marketed and on an analysis of information from clinical trials
and scientific literature.
The analyses revealed that some who have taken Chantix and Zyban have
reported experiencing unusual changes in behavior, become depressed, or had
their depression worsen, and had thoughts of suicide or dying. In many cases,
the problems began shortly after starting the medication and ended when the
medication was stopped. However, some people continued to have symptoms after
stopping the medication. Also, in a few cases, the problems began after the
medication was stopped.
Neither Chantix nor Zyban contain nicotine and some of
these symptoms may be a response to nicotine withdrawal. People who stop smoking
may experience symptoms such as depression, anxiety, irritability, restlessness,
and sleep
disturbances. However, some patients who were using these products experienced
the reported adverse events while they were still smoking.
In addition to the Boxed Warning, the FDA also is requesting more information
in the Warnings section of the prescribing information and updated information
in the Medication Guide for patients that further discuss the risk of mental
health events when using these products.
Manufacturers also will be required to conduct a
clinical trial to determine
how often serious neuropsychiatric symptoms occur in patients using various
smoking cessation therapies, including patients who currently have psychiatric
disorders. The FDA's review of adverse events for patients using nicotine
patches did not identify a clear link between those medications and suicidal
events.
Chantix is manufactured by New York-based Pfizer Inc. Zyban is manufactured
by GlaxoSmithKline, Brentford, Middlesex, United Kingdom.
SOURCE: FDA News Release, July 1, 2009
Last Editorial Review: 7/1/2009
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