FDA Drug Safety Newsletter: Volume 1, Number 4, Summer 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

	•	Mefloquine Hydrochloride Reports of pneumonitis associated with the use of mefloquine (marketed as LARIAM and generics)

	•	Lenalidomide Reports of serious skin reactions associated with the use of lenalidomide (marketed as REVLIMID)

	•	Amiodarone-Simvastatin Interaction Reports of rhabdomyolysis associated with the concomitant use of amiodarone (marketed as CORDARONE and PACERONE) and simvastatin (marketed as ZOCOR and generics) or simvastatin-combination products (marketed as VYTORIN and SIMCOR)

	•	Icodextrin - Portable Blood Glucose Monitor Test Strip Interaction Reports of iatrogenic, sometimes fatal, hypoglycemia in association with icodextrin (EXTRANEAL) and certain point-of-care blood glucose monitors utilizing glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase (GDO) reagents

Feature Article

	•	Medication Errors A review of the challenges and efforts to reduce medication errors

Drug Safety Communications: List of advisories on drug safety posted on FDA's Web site from May 1, 2008 through August 31, 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

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

Contributing Authors:
S. Christopher Jones, PharmD, MS (mefloquine hydrochloride)
Gregory D. Busse, PhD (medication errors)

Art Direction and Design: Michael Ermarth

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