Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Warning for Rx smoking-cessation drugs

This article was originally published in The Tan Sheet

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)

You may also be interested in...



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

US FDA And NIST Form Partnership To Boost Advanced Manufacturing Techniques

The US FDA and NIST have agreed to help industry modernize and update pharmaceutical manufacturing methods and to improve supply chain resilience.

Medtronic Looks To Adaptive DBS To Advance Treatment Of Parkinson’s Disease

Medtronic is sponsoring a trial to evaluate its adaptive deep brain stimulation technology, a unique feature of the Percept PC device for treating Parkinson’s disease.

Topics

UsernamePublicRestriction

Register

OM013164

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel