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【medical-news】FDA警告：流感药物诱发儿童行为异
WASHINGTON - Government health regulators recommended adding label precautions about neurological problems seen in children who have taken flu drugs made by Roche and GlaxoSmithKline.
The 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
http://news.yahoo.com/s/ap/20071124/ap_on_he_me/fda_tamiflu_safety;_ylt=ArwDgQn6XwnktqH.NYe_lVPVJRIF
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FDA: Flu drugs affecting kids' behavior
FDA警告：流感药物诱发儿童行为异常
WASHINGTON - Government health regulators recommended adding label precautions about neurological problems seen in children who have taken flu drugs made by Roche and GlaxoSmithKline.
华盛顿--政府卫生官员建议增加罗氏和葛兰素史克生产的流感药物的标签警示，因儿童服用后出现神经问题。
The 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.
周五FDA发布了罗氏Tamiflu和葛兰素Relenza的安全性复审决议。下周，将安排外界的一个儿科专家小组对几个用于儿童的该类药物的安全性进行复审。
FDA began reviewing Tamiflu's safety in 2005 after receiving reports of children experiencing neurological problems, including hallucinations and convulsions.
在2005年接到儿童出现神经方面问题（包括幻觉和抽搐）的报告后，FDA开始对Tamiflu的安全性进行复审。
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."
25名21岁以下的患者在服用该药时死亡，这些患者大部分分布在日本。5例死亡是因为“儿童从窗户或阳台跌落或者死于车祸“。
There have been no child deaths connected with Relenza, but regulators said children taking the drug have shown similar neurological problems.
虽然没有儿童因服用Relenza而死亡，但卫生官员称儿童服用该药已经显示了类似的神经方面问题。
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.
虽然FDA称尚不清楚这些问题是否与这些药物有直接关系，但它建议在amiflu和Relenza的标签中增加关于可能副作用的警示。
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.
除了可能是药物副作用外，FDA称行为变化也可能源于一种罕见的流感病毒或对该药的一种罕见遗传反应。
Company representatives were not immediately available for comment
公司代表未做及时回应。
http://news.yahoo.com/s/ap/20071124/ap_on_he_me/fda_tamiflu_safety;_ylt=ArwDgQn6XwnktqH.NYe_lVPVJRIF 编译：（中文字符：349）
http://news.yahoo.com/s/ap/20071124/ap_on_he_me/fda_tamiflu_safety;_ylt=ArwDgQn6XwnktqH.NYe_lVPVJRIF
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作者:admin@医学,生命科学 2011-03-15 05:11
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