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FDA to Remove, Update Boxed Warnings on Mental Health Side Effects of Chantix, Zyban

The Food and Drug Administration (FDA) announced Friday that it will remove the boxed warning related to serious mental health side effects from the smoking cessation medication Chantix (varenicline). The language describing the serious mental health side effects seen in patients quitting smoking will also be removed from the boxed warning in the Zyban (bupropion) label. (Because the active ingredient in Zyban is in the antidepressant class, the label carries the class boxed warning for suicidality and antidepressants. This language will remain in a boxed warning for Zyban and other...

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Published By: Psychiatric News - Monday, 19 December, 2016

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