FDA to Probe Deaths of Kids on Tamiflu

By ANDREW BRIDGES, Associated Press Writer

Federal health advisers are looking into the deaths of 12 Japanese children who took Tamiflu, part of their annual safety review of the anti-flu medication and seven other drugs.

There are no reports of deaths in the United States or Europe associated with Tamiflu.

"Based on the information we have right now, we cannot say definitively there is a causal relation between the drug and the children"s death," Dr. Murray Lumpkin, the deputy commissioner of the U.S. Food and Drug Administration, said Thursday.

The Japanese deaths were detailed in papers released in advance of a Food and Drug Administration advisory committee meeting Friday.

An update by FDA staff also includes reports of 32 "neuropsychiatric events" associated with Tamiflu, all but one experienced by Japanese patients. Those cases included delirium, hallucinations, convulsions and encephalitis.

"Clearly, any time you get a report of a death or a serious occurrence, you want to look into it," Lumpkin said.

The FDA sought and received more information from the Swiss pharmaceutical company Roche Holding AG, which makes Tamiflu, and from Japanese health authorities. It has not issued any warnings or initiated any other action, spokeswoman Susan Bro said.

Lumpkin said "millions and millions" of patients have safely used the drug to treat the flu.

Complicating the issue is that many of the Japanese death and adverse reaction reports list symptoms commonly associated with the flu, he said.

"It is very difficult, when the underlying disease causes what it is being reported, to figure out: Is it the underlying disease? Is it the drug?" said Lumpkin.

A Roche spokesman did not immediately return an e-mail message seeking comment. Roche has supplied the FDA with two additional studies it commissioned that evaluated the safety of Tamiflu in pediatric patients.

Japan"s Health Ministry warned last week that Tamiflu may induce "strange behavior" after reporting that two teenage boys died shortly after taking the medicine.

"Roche has carefully reviewed these events and has concluded that a causal link cannot be established," the company said in a statement released on Monday.

However, the Japanese distributor of the Roche-patented drug told health officials it could not rule out a link between Tamiflu and the deaths. Tamiflu is extensively used to treat children in Japan, according to the FDA.

The U.S. labeling for Tamiflu lists nausea and vomiting as its most serious side effects. Its labeling in Japan includes any adverse effects that have been reported — including impaired consciousness, abnormal behavior and hallucinations — regardless of whether they can be attributed to the drug, according to Roche.

Tamiflu is one of the few drugs believed effective in treating bird flu, which health officials fear could spark a pandemic should it mutate into a form easily passed from human to human.

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Google"s translation, very interesting...

粮食与药物管理局试探小孩死亡在Tamiflu

由ANDREW   BRIDGES, 美联社作家

联邦健康参谋正在调查采取Tamiflu 的一部分 反流感疗程和七种其它药物的他们的每年安全回顾12 个日本孩子的 死亡。死亡没有报告自美国或欧洲与Tamiflu 交往。"  根据我们现 在有的信息, 我们不能明确地说有原因联系在这种药物并且 children"s 死亡, "  博士Murray Lumpkin, 美国食物和药物 管理的代理委员之间, 星期四说。日本死亡被选派在文件里发布在 食物和药物管理咨询委员会会议星期五前。一次更新由FDA 职员并 且包括报告32 " neuropsychiatric 事件" 与Tamiflu, 所有交往除 了一个由Japanese 患者体验。那些案件包括神志失常, 幻觉, 抽风 和脑炎。" 清楚地, 在时侯你得到死亡或严肃的发生的报告, 你想 调查它, " Lumpkin 说。粮食与药物管理局寻找和获得更多信息从 瑞士制药公司Roche 藏品AG, 做Tamiflu,  并且从日本卫生局。它 没发布任何警告或没创始什么举动, 女发言人Susan Bro 说。 Lumpkin 认为"成千上万和成千上万" 患者安全地使用这种药物对待 流感。使复杂化这个问题是许多日本死亡和有害反应报告目录症状 共同地联系与流感, 他说。" 它非常难, 当这种部下疾病导致什么 它正在被报告, 出现: 是这这种部下疾病吗? 是它这种药物?" 说 Lumpkin 。Roche  发言人立刻没有退回电子邮件消息寻找评论。 Roche 把它委任评估Tamiflu 安全在小儿科患者的粮食与药物管理 局供给二项另外的研究。Japan"s 健康部警告Tamiflu 也许引 诱" 奇怪的行为" 在报道的上个星期以后二个十几岁的男孩去世在 采取医学之后。" Roche 仔细地回顾这些事件和结束一个原因链接 不可能被建立,  在星期一" 这个公司说在声明发布。然而, 这种 Roche 给予专利的药物的日本经销商告诉健康官员它没有能派出一 个链接在Tamiflu 和死亡之间。Tamiflu 广泛地被使用对待孩子在 日本,  根据粮食与药物管理局。美国贴标签于为Tamiflu  列出恶 心和呕吐象它的最严肃的副作用。它贴标签于在日本包括被报告 . . 包括被削弱的知觉, 反常行为和幻觉. . 的所有不利影响是否 他们可能归因于这种药物, 根据Roche 。Tamiflu 是一个少数药物 被相信的有效在对待的鸟流感, 健康官员恐惧能激励pandemic 如果 它mutate 入形式容易地通过从人到人。

[ Last edited by laurel on 2005/11/17 at 15:01 ]
－－－－－－－－－－－这种所谓疫苗,有什么证据表明它确实有效啊?!
－－－－－－－－－－－新华社河内１２月２９日电（记者黄海敏　刘翔霄)越南热带病研究院院长阮德贤表示，越南已发现４名死于禽流感的患者对禽流感特效药“达菲”产生抗体。

　　据此间媒体２９日报道，阮德贤２８日在一次非典及禽流感防控指导委员会会议上表示，上述４名禽流感患者虽然服用了“达菲”，但仍在不久后死亡。报道称，病人对“达菲”产生抗体并非异常，目前已有两种禽流感药物尚未在越南使用就已产生抗体。目前也没有证据表明，患者死亡是由服用“达菲”所致。

　　另外，当地医疗专家指出，越南多数禽流感患者死亡的原因是未能得到及时诊治，达菲仅对患者早期治疗有效果。

　　目前，越南禽流感疫情仍未得到有效控制。越南卫生部２８日表示，自２００３年底禽流感首次大规模暴发以来，越南已发现９３名禽流感患者，其中４２人死亡。


目前他们采取两种方式继续忽悠,一是没有及时(48小时内)服药,二是禽流感病毒发生了变易.