Chantix and Zyban
Warning - News Article
Anti-Smoking Drugs Get FDA ’Black-Box’ Warning
Chantix and Zyban to risk of psychiatric side effects, including
By Steven Reinberg
1 (HealthDay News) -- Two drugs prescribed to help people quit
smoking, Chantix and Zyban, will now carry "black-box" warnings
on the potential risks of psychiatric problems, including
depression and suicidal thoughts, U.S. health officials said
The U.S. Food
and Drug Administration said it was mandating the black-box
warnings, the strictest possible, based on reports to the agency
of these side effects and on a review of clinical trials and
requiring the manufacturers of the smoking-cessation drugs
Chantix and Zyban to add a new boxed warning highlighting the
risk of serious mental health symptoms with use of these
products," Dr. Curt Rosebraugh, director of the FDA’s Office of
Drug Evaluation II, said during a Wednesday teleconference.
agency’s review found that some people who used Chantix (varenicline)
and Zyban (bupropion) experienced unusual changes in behavior,
became depressed, or had their depression worsen and had
thoughts of suicide or dying, the FDA said.
Rosebraugh said there were reports of 98 suicides and 188
suicide attempts involving Chantix, and 14 suicides and 17
attempts reported with Zyban.
users, the problems started soon after they began taking the
drugs and ended when they stopped taking them. Some users,
however, continued to have symptoms even after stopping the
drugs. In a few cases, the problems started after the drugs were
stopped, Rosebraugh said.
taking these drugs who develop any of these symptoms should be
monitored until their symptoms clear up, even if symptoms
develop after stopping these drugs, Rosebraugh added.
drugs don’t contain nicotine, and some of the symptoms may be
caused by nicotine withdrawal. People who stop smoking can
suffer from depression, anxiety, irritability, restlessness, and
sleep disturbances, the FDA noted.
patients who were using the drugs experienced the side effects
while they were still smoking, the agency said. Rosebraugh said
the risk of using these drugs needs to be balanced with the
substantial benefits of quitting smoking, and these drugs can be
"Stopping smoking is a goal we all want to work towards, and if
people need medication to do it they should have access to it.
So we don’t want to scare people off from trying to use a
medication to stop smoking; we just want them to be carefully
monitored," he said.
In addition to
the warning, the FDA is requesting more prescribing information
in the warning section of the label, and new information in the
Medication Guide for patients that discusses the risk of mental
health events while using these products.
The makers of
the drugs will also be required to do a clinical trial to see
how often serious psychiatric symptoms occur in patients using a
variety of therapies to help them quit smoking, including
patients who currently have psychiatric disorders, Rosebraugh
said. Results of this trial won’t be known for several years, he
manufactured by Pfizer Inc. Zyban is made by GlaxoSmithKline.
update underscores the important role of health-care providers
in treating smokers attempting to quit and provides specific
information about Chantix and instructions that physicians and
patients should follow closely," Dr. Briggs W. Morrison, senior
vice president for the Primary Care Development Group at Pfizer,
said in a prepared statement. "Quitting smoking is one of the
best things people can do for their health, but the quitting
process is both difficult and complex."
review of consumers using nicotine patches did not find a link
between patches and psychiatric side effects.
antidepressant Wellbutrin, which contains the same active
ingredient as Zyban, already carries a black-box warning.
ORIGINAL SOURCE: July 1, 2009, teleconference with Curt
Rosebraugh, M.D., M.P.H., director, Office of Drug Evaluation
II, U.S. Food and Drug Administration