FDA Drug Safety Newsletter: Volume 2, Number 2, 2009

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FDA/Center for Drug Evaluation and Research

This publication provides postmarketing information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting.

In This Issue

Print Version

Editor's Note

Postmarket Reviews

	•	Varenicline and Bubropion Reports of suicidality associated with use of varenicline (marketed as CHANTIX) and bupropion (marketed as ZYBAN and GENERICS)

	•	Abacavir Information for healthcare professionals on an abacavir (marketed as ZIAGEN, EPZICOM, and TRIZIVIR) hypersensitivity reaction, HLA-B*5701, and skin patch testing

	•	Atomoxetine Reports of serious liver injury associated with use of atomoxetine (marketed as STRATTERA)

FDA Patient Safety News

Drug Safety Communications: List of drug safety advisories posted on FDA’s Web site from September 1, 2008 through November 30, 2008, with related links

U.S. Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
5600 Fishers Lane, Rockville MD 20857-0001
Phone: 1-888-INFO-FDA (1-888-463-6332)

Acknowledgments:
Office of Surveillance and Epidemiology and Office of New Drugs

Renan A. Bonnel, PharmD, MPH
Senior Scientific Editor

Gregory D. Busse, PhD
Editor

Contributing Authors:
Martin Pollock, PharmD, Joann H. Lee, PharmD (varenicline and bupropion)
Ida-Lina Diak, PharmD, John Senior, MD (atomoxetine)
Wendy Carter, MD, Kendall Marcus, MD (abacavir)

Art Direction and Design: Elena H. Ketelhut

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