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

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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

Postmarketing Reviews

	•	Exenatide (marketed as BYETTA): Acute Pancreatitis

	•	PHOSPHODIESTERASE TYPE 5 (PDE5) INHIBITORS Sildenafil citrate (marketed as VIAGRA and REVATIO), vardenafil hydrochloride (marketed as LEVITRA), and tadalafil (marketed as CIALIS): Sudden Hearing Loss

	•	TUMOR NECROSIS FACTOR ALPHA (TNF-α) ANTAGONISTS Infliximab (marketed as REMICADE), etanercept (marketed as ENBREL), and adalimumab (marketed as HUMIRA): Serious Skin Reactions

New Molecular Entity (NME) - 3 Years Later

Duloxetine (marketed as CYMBALTA)

Feature Article

Pharmacogenomics and Its Role In Drug Safety

Drug Safety Communications

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, PharmD, MPH
Senior Scientific Editor

Acknowledgments:
Office of Surveillance and Epidemiology, Office of New Drugs, and Office of Translational Sciences

Contributing Authors:
Robert Boucher, MD, MPH (PDE5 inhibitors)
Alaina Fournier, PhD (Pharmacogenomics)
Hyon Kwon, PharmD, MPH (Infliximab)

Art Direction and Design: Michael Ermarth

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