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U.S. Department of Health and Human Services

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FDA Drug Safety Newsletter - Volume 2, Number 3, 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 secondary exposure of children to testosterone gel products (marketed as AndroGel 1% and Testim 1%) 

Reports of serious cardiopulmonary adverse events in neonates associated with precipitation of ceftriaxone (marketed as Rocephin and generics) and calcium salt in the body

Reports of loss of sense of smell associated with the use of zinc-containing intranasal cold products (marketed as Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size)

Drug Safety Oversight Board 

Quarterly summary of each board meeting with related links

Drug Safety Communications

List of drug safety advisories posted on FDA’s Web site from April 1, 2009, to July 1, 2009, with related links

  Newsletter Cover - doctor, baby, table to contents

U.S. Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
10903 New Hampshire Avenue White Oak Campus 
Silver Spring, MD 20993
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:
Mary Dunne Roberts, MD, Hina Mehta, PharmD (testosterone)
Kelly Yoojung Cao, PharmD, Charles E. Lee, MD, MPH, Robert Boucher, MD, MPH (zinc-containing intranasal cold products)

Art Direction and Design: Elena H. Ketelhut

We value your comments. Please provide us with feedback by reaching us at Comments. All text in the Drug Safety Newsletter is in the public domain and may be used and reprinted without permission; citation as to source, however, is appreciated.
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