Warning on Neuropsychiatric Effects from Smoking Cessation Drugs (Chantix, Zyban, Wellbutrin)

FDA is requiring that two drugs used to help people stop smoking carry new warnings about the risk of serious neuropsychiatric effects. The drugs are Chantix (varenicline) and Zyban (bupropion). The same warnings will be required for other bupropion products such as Wellbutrin, which are used to treat depression and seasonal affective disorder.

FDA's analysis of adverse event reports shows that when neuropsychiatric symptoms occur, they usually develop during drug treatment, but symptoms can also develop after the drug is stopped. Some patients on these drugs who had no history of psychiatric illness experienced suicidal ideation and behavior for the first time. The drugs have also been associated with a worsening of symptoms in patients with pre-existing psychiatric disorders.

Healthcare professionals should advise patients to stop taking Chantix or Zyban and contact a healthcare provider immediately if they experience agitation, hostility, depressed mood, atypical changes in thinking or behavior, suicidal thoughts or suicidal behavior. If the drugs are stopped because of neuropsychiatric symptoms, patients should be monitored until the symptoms resolve.

Family members and caregivers also have an important role. They should watch for changes in mood or behavior in the person taking the drug, and contact the healthcare provider if they notice those changes. But it is also important for patients and caregivers to realize that nicotine withdrawal itself can cause behavioral changes, even in people who are not taking these drugs.

It's important to remember that Chantix and Zyban can be effective in helping people to stop smoking, which can have significant health benefits. So these benefits have to be weighed against the small but potentially serious risk of neuropsychiatric effects from the drugs.

FDA Patient Safety News: September 2009

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=90#3

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Education

Tags:

• Chantix
• Zyban
• Wellbutrin
• stop smoking
• cigarettes
• psychiatric
• side effect
• depression
• drug
• FDA