Chantix advisory
This article was originally published in The Tan Sheet
Executive Summary
FDA announced Feb. 1 new safety warnings for Pfizer's prescription smoking cessation drug Chantix (varenicline), sayingthe medication is proven effective in helping patients quit smoking, but warned neuropsychiatric symptoms have occurred in some patients. FDA also requests that Pfizer add new warnings to the prescription information or the label. In the advisory, the agency notes patients should report histories of psychiatric illness to their health care providers before starting the medication and that providers and patients should monitor mood and behavior changes in the person being treated. The announcement follows a review FDA conducted after issuing an Early Communication in November, stating it was evaluating reports related to changes in behavior and mood...