Executive Summary

OTC products could see prescription users switching after FDA requires warnings on Rx smoking-cessation drugs about the risk of serious mental health events including behavior changes, depressed mood, hostility and suicidal thought. The agency July 1 said boxed warnings must be added to the prescribing information for Pfizer's Chantix (varenicline) and GlaxoSmithKline's Zyban (bupropion hydrochloride). FDA, which also required similar information for bupropion marketed as the antidepressant Wellbutrin and generics, based its decision on a review of adverse event reports submitted and an analysis of clinical trials and scientific literature. Smoking-cessation OTC manufacturers, including GSK with Nicorette gum, NicoDerm patches and Commit lozenges, could use this warning to promote the safety of its products. In mid 2008 GSK advertised its OTC products were not linked to FDA's warning that use of Chantix has been linked to psychiatric adverse events (1"The Tan Sheet" June 30, 2008)