ABSTRACT
Drug safety is an international priority. However, all drugs have adverse effects; what ultimately matters is if the benefits of a drug outweigh the risks. To this end, a scientifically accurate characterization of risks and benefits is essential. A drug like varenicline which is the most effective anti-smoking treatment in existence has a black box warning for neuropsychiatric events and suicide risk despite the absence of a signal derived from RCTs and large-scale well controlled observational studies. The evidence in support of this association is restricted to spontaneous reports of such events. It seems unlikely that the frequency of spontaneous reports is indicative of a causal association in the absence of any signal based on higher quality randomized and observational data (Gibbons and Mann 2013). Nevertheless, the black box warning has limited use of this highly effective smoking cessation medication the consequences of which must include increased risk of lung cancer and death. There is something seriously wrong with this risk-benefit equation.
