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U.S. Department of Health and Human Services

Drugs

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FDA Drug Safety Newsletter - Volume 1, Number 2, Winter 2008

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

Postmarketing Reviews

Sildenafil citrate (marketed as VIAGRA and REVATIO), vardenafil hydrochloride (marketed as LEVITRA), and tadalafil (marketed as CIALIS): Sudden Hearing Loss

Infliximab (marketed as REMICADE), etanercept (marketed as ENBREL), and adalimumab (marketed as HUMIRA): Serious Skin Reactions

New Molecular Entity (NME) - 3 Years Later

Feature Article

Drug Safety Communications

 picture of Winter 2008 Drug Safety Newsletter 
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)

Renan A. Bonnel, Pharm.D., M.P.H
Senior Scientific Editor

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

Contributing Author:
Jennie Chang, Pharm.D. (Rituximab, Temozolomide)

We value your comments. Please let us know 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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