The authors conclude with a section entitled "What Needs to Happen?"

In my view, this refutation and undermining of its own black box warning violates accepted standards of pharmaceutical company conduct, and should prompt either penalties or the removal of the drug from the market. If Pfizer is going to publicly undermine the required black box warning, then clearly that warning is not adequate to protect consumers and the FDA must either penalize Pfizer so that it desists from this behavior or pull the drug from the market since it is becoming clear that the company is undermining that warning in the eyes of the public.

The report includes pictures of product images and advertisements that appear to showcase the sweet, fruit flavorings of these products.

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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