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...
You may also be interested in...
Cigarette Tax Hike Sparks NRT Marketing Opportunities
A 62-cent federal cigarette tax hike may push smokers to quit the increasingly expensive habit - creating a marketing opportunity for nicotine replacement therapy makers
GSK Lights Fire Under Educating Consumers On Smoking Cessation OTCs
GlaxoSmithKline says it is stepping up public relations efforts to tell consumers that its OTC smoking cessation products are not linked to problems reported with Pfizer's Rx drug Chantix
GSK offers pilots NRT after Chantix ban
GlaxoSmithKline is offering one free 48-count carton of Commit 4 mg nicotine replacement therapy lozenges to all licensed commercial and private pilots following the Federal Aviation Administration's decision to ban Pfizer's Rx smoking cessation pill, Chantix (varenicline), GSK announces May 23. The offer is available through June 30. The FAA decision came after the nonprofit Institute for Safe Medication Practices used FDA adverse event data to find potential risks for Chantix include heart arrhythmias, seizures, diabetes, skin reactions and vision disturbances in addition to the known psychiatric side-effects. FDA released safety warnings about possible neuropsychiatric side-effects for Chantix in February (1"The Tan Sheet" Feb. 4, 2008, In Brief)...