FDA Drug Safety Newsletter: Drug Safety Communications

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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. For more information, visit the FDA Drug Safety Newsletter Fact Sheet at www.fda.gov/cder/dsn/factsheet.htm.

In This Issue

Print Version

Editor's Note

Postmarketing Reviews

	•	Pemetrexed Reports of radiation recall associated with pemetrexed (marketed as ALIMTA)

	•	Natalizumab Reports of serious liver injury associated with natalizumab (marketed as TYSABRI)

	•	Carbamazepine Reports of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with carbamazepine (marketed as CARBATROL, EQUETRO, TEGRETOL and other associated generics) in Asians positive for the HLA-B*1502 allele

Drug Safety Communications: List of advisories on drug safety posted on FDA’s Web site from January 1, 2008 through April 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)

Renan A. Bonnel, PharmD, MPH
Senior Scientific Editor

Gregory D. Busse, PhD
Editor

Contributing Authors:
Charlene Flowers, RPh, Mark Avigan, MD, CM (natalizumab)
Ron Farkas, MD, PhD (carbamazepine)

Art Direction and Design: Michael Ermarth

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

We value your comments. Please let us know by reaching us at www.fda.gov/cder/comment.htm. 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.