FDA: Boxed Warning Required for Varenicline, Buproprion Due to Risk of Suicidal Behaviour
ROCKVILLE, Md -- July 1, 2009 -- The US Food and Drug Administration (FDA) has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products.
These symptoms include changes in behaviour, hostility, agitation, depressed mood, suicidal thoughts and behaviour, and attempted suicide.
The same changes to the prescribing information and Medication Guide for patients will also be required for bupropion products (Wellbutrin and generics) that are indicated for the treatment of depression and seasonal affective disorder.
The added warnings are based on the continued review of post-marketing adverse event reports for varenicline and bupropion received by the FDA.
These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and suicidal behaviour in patients with no history of psychiatric disease.
Some of these cases may have been confounded by symptoms typically seen in people who have stopped smoking and are experiencing withdrawal from nicotine.
Healthcare professionals should advise patients to stop taking varenicline or bupropion and contact a healthcare provider immediately if they experience agitation, depressed mood, and any changes in behaviour that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior.
If varenicline or bupropion is stopped due to neuropsychiatric symptoms, patients should be monitored until the symptoms resolve.
SOURCE: US Food and Drug Administration
posted by Georgina Cannon LifeChanger Blog @ 9:49 AM
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