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U.S. Department of Health and Human Services


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Drug Safety and Availability

FDA Drug Safety Newsletter - Volume 2, Number 1, 2009

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

Editor's Note

Postmarket Reviews

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

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

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

PDF version of Drug Safety Newsletter