Abstract
The Food and Drug Administration and varenicline: should risk communication be improved?
Highlights
Black Box warnings are the strongest warning the Food and Drug Administration (FDA) issues, and they are ‘designed to call attention to serious or life-threatening risks’ [3]
Black Box warnings indicate either when there is a serious adverse reaction with ‘some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event’ or to ‘highlight important information for prescribers’ [3]
In the case of varenicline, people who smoke are very different from the general population; on average they are poorer, sicker and more likely to have mental health problems [16]
Summary
Patients prescribed medications are often at higher risk of adverse events than the general population, even before they start treatment. The fact that a medication is associated with adverse events is not necessarily informative for patients. In the case of varenicline, people who smoke are very different from the general population; on average they are poorer, sicker and more likely to have mental health problems [16]. Smokers prescribed varenicline recorded in the FDA’s AERS were likely to be at increased risk of neuropsychiatric problems before they were prescribed varenicline. The case reports could not take these differences into account in their analysis. The adverse event reports are likely to be unreliable evidence of the differences in risks of adverse events faced by smokers if they took varenicline or other treatments
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