Emerging evidence suggests the smoking-cessation drug varenicline is among a growing list of medications that might cause serious psychiatric adverse events.
A new analysis by the US Food and Drug Administration (FDA) adds to evidence that varenicline might be associated with an increased risk of suicidal thoughts and behavior, including among patients with no psychiatric history. The results, which were published in January, follow warnings from the agency that such a link is likely, as well as label changes noting a possible risk.