Just passing along info - Medscape article antiviral drug

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Antiviral Drug Labels Get Warnings for Neuropsychiatric Changes

March 4, 2008 — The safety labeling for oseltamivir phosphate

(Tamiflu, Roche Laboratories Inc) has been revised to include

stronger warnings regarding the risk for neuropsychiatric adverse

events, the US Food and Drug Administration (FDA) warned healthcare

professionals today. The revisions were the result of recommendations

made by the agency's Pediatric Advisory Committee meeting held in

November 2007.

GlaxoKline Plc has also added a warning to the label of

zanamivir (Relenza) for neuropsychiatric adverse events, as reported

by Reuters Health.

Symptoms of delirium and abnormal behavior leading to sometimes fatal

self-injury have been reported with use of oseltamivir for the

treatment of influenza, primarily in Japan, according to an alert

issued by MedWatch, the FDA's safety information and adverse event

reporting program. These events occurred primarily among pediatric

patients and were often abrupt in onset and resolution.

Although a causal role for the drug cannot be established because of

the voluntary nature of the reporting, they appear to be uncommon

according to oseltamivir usage data. Also, children and adolescents

with influenza may be at increased risk for seizures, confusion, or

abnormal behavior during the early stages of their illness even if it

remains untreated.

http://www.medscape.com/viewarticle/570996?src=mp