FW: [abmd] FDA: Flu Drugs Affecting Kids' Behavior

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From: abmd [mailto:abmd ] On Behalf Of Holly

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Sent: Saturday, November 24, 2007 7:03 AM

FDA: Flu Drugs Affecting Kids' Behavior

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Nov 24, 2:36 AM (ET)

WASHINGTON (AP) - Government

<http://apnews.excite.com/article/20071124/D8T3TA680.html##> health

regulators recommended adding label precautions about neurological problems

seen in children who have taken flu drugs made by Roche and GlaxoKline.

The <http://apnews.excite.com/article/20071124/D8T3TA680.html##> Food and

Drug Administration on Friday released its safety review of Roche's Tamiflu

and Glaxo's Relenza. Next week, an outside group of pediatric experts is

scheduled to review the safety of several such drugs when used in children.

FDA began reviewing Tamiflu's safety in 2005 after receiving reports of

children experiencing neurological problems, including hallucinations and

convulsions.

Twenty-five patients under age 21 have died while taking the drug, most of

them in Japan. Five deaths resulted from children " falling from windows or

balconies or running into traffic. "

There have been no child deaths connected with Relenza, but regulators said

children taking the drug have shown similar neurological problems.

While FDA said it isn't clear whether the problems are directly related to

the drugs, it recommends adding language about the possible side effects to

labeling for physicians who prescribe Tamiflu and Relenza.

Besides being a drug side effect, the agency said the behaviors alternately

could result from an unusual strain of flu or a rare genetic reaction to the

drug.

Company representatives were not immediately available for comment.

" The way to see by faith is to shut the eye of reason " . lin