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Drug Safety and Availability

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

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

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

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)

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

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


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