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...
糧食與藥物管理局試探小孩死亡在Tamiflu
由ANDREW BRIDGES, 美聯(lián)社作家
聯(lián)邦健康參謀正在調(diào)查采取Tamiflu 的一部分 反流感療程和七種其它藥物的他們的每年安全回顧12 個日本孩子的 死亡。死亡沒有報告自美國或歐洲與Tamiflu 交往。" 根據(jù)我們現(xiàn) 在有的信息, 我們不能明確地說有原因聯(lián)系在這種藥物并且 children"s 死亡, " 博士Murray Lumpkin, 美國食物和藥物 管理的代理委員之間, 星期四說。日本死亡被選派在文件里發(fā)布在 食物和藥物管理咨詢委員會會議星期五前。一次更新由FDA 職員并 且包括報告32 " neuropsychiatric 事件" 與Tamiflu, 所有交往除 了一個由Japanese 患者體驗。那些案件包括神志失常, 幻覺, 抽風 和腦炎。" 清楚地, 在時侯你得到死亡或嚴肅的發(fā)生的報告, 你想 調(diào)查它, " Lumpkin 說。糧食與藥物管理局尋找和獲得更多信息從 瑞士制藥公司Roche 藏品AG, 做Tamiflu, 并且從日本衛(wèi)生局。它 沒發(fā)布任何警告或沒創(chuàng)始什么舉動, 女發(fā)言人Susan Bro 說。 Lumpkin 認為"成千上萬和成千上萬" 患者安全地使用這種藥物對待 流感。使復雜化這個問題是許多日本死亡和有害反應報告目錄癥狀 共同地聯(lián)系與流感, 他說。" 它非常難, 當這種部下疾病導致什么 它正在被報告, 出現(xiàn): 是這這種部下疾病嗎? 是它這種藥物?" 說 Lumpkin 。Roche 發(fā)言人立刻沒有退回電子郵件消息尋找評論。 Roche 把它委任評估Tamiflu 安全在小兒科患者的糧食與藥物管理 局供給二項另外的研究。Japan"s 健康部警告Tamiflu 也許引 誘" 奇怪的行為" 在報道的上個星期以后二個十幾歲的男孩去世在 采取醫(yī)學之后。" Roche 仔細地回顧這些事件和結(jié)束一個原因鏈接 不可能被建立, 在星期一" 這個公司說在聲明發(fā)布。然而, 這種 Roche 給予專利的藥物的日本經(jīng)銷商告訴健康官員它沒有能派出一 個鏈接在Tamiflu 和死亡之間。Tamiflu 廣泛地被使用對待孩子在 日本, 根據(jù)糧食與藥物管理局。美國貼標簽于為Tamiflu 列出惡 心和
嘔吐象它的最嚴肅的副作用。它貼標簽于在日本包括被報告 . . 包括被削弱的知覺, 反常行為和幻覺. . 的所有不利影響是否 他們可能歸因于這種藥物, 根據(jù)Roche 。Tamiflu 是一個少數(shù)藥物 被相信的有效在對待的鳥流感, 健康官員恐懼能激勵pandemic 如果 它mutate 入形式容易地通過從人到人。
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Last edited by laurel on 2005/11/17 at 15:01 ]
－－－－－－－－－－－這種所謂疫苗,有什么證據(jù)表明它確實有效啊?!
－－－－－－－－－－－新華社河內(nèi)１２月２９日電（記者黃海敏 劉翔霄)越南熱帶病研究院院長阮德賢表示，越南已發(fā)現(xiàn)４名死于禽流感的患者對禽流感特效藥“達菲”產(chǎn)生抗體。
據(jù)此間媒體２９日報道，阮德賢２８日在一次非典及禽流感防控指導委員會會議上表示，上述４名禽流感患者雖然服用了“達菲”，但仍在不久后死亡。報道稱，病人對“達菲”產(chǎn)生抗體并非異常，目前已有兩種禽流感藥物尚未在越南使用就已產(chǎn)生抗體。目前也沒有證據(jù)表明，患者死亡是由服用“達菲”所致。
另外，當?shù)蒯t(yī)療專家指出，越南多數(shù)禽流感患者死亡的原因是未能得到及時診治，達菲僅對患者早期治療有效果。
目前，越南禽流感疫情仍未得到有效控制。越南衛(wèi)生部２８日表示，自２００３年底禽流感首次大規(guī)模暴發(fā)以來，越南已發(fā)現(xiàn)９３名禽流感患者，其中４２人死亡。
目前他們采取兩種方式繼續(xù)忽悠,一是沒有及時(48小時內(nèi))服藥,二是禽流感病毒發(fā)生了變易.
