The requirement by the FDA that this black box warning be placed on Chantix is based on the agency's assessment of hundreds of cases of suicides that occurred in patients who had recently been treated with the drug, as well as thousands of cases of other serious adverse neuropsychiatric symptoms associated with the use of Chantix. In making a decision to require a black box warning, the agency takes into consideration the likelihood that the observed association between the drug and the adverse effects is a causal one.

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