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【英文报刊翻译080328】FDA调查可能促使自杀的默沙东药品
来源:沪江论坛 | 时间:2008-03-28 | 作者:patricia4402 | 阅读:893 次 | [ ] [收藏] [划词] 评论 0 条

请大家阅读下文,了解大意后翻译紫色的一段。

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FDA Probes Merck Drug, Possible Suicides
By THE ASSOCIATED PRESS
Published: March 27, 2008

The Food and Drug Administration said Thursday it is investigating a possible link between Merck's best-selling Singulair and suicide. FDA said it is reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who have taken the popular allergy and asthma drug.
周四,美国食品和药物管理局(FDA)表示,他们正在调查可能存在于默沙东公司目前最畅销的药品"欣流"与自杀事件之间的一种联系。 FDA表治疗示,他们将再次审核少数报告,内容包括一些服用过现今流行的治疗过敏和哮喘药物的病人的情绪变化,自杀行为和自杀案例。

With sales of $4.3 billion last year, Singulair is used by millions of patients in the U.S, according to Merck.. First approved in 1998, it's part of a class of asthma and allergy drugs that includes AstraZeneca PLC's Accolate and Critical Therapeutics Inc.'s Zyflo.
默沙东公司表示,去年"欣流"的销售额达到43亿美元。现在,它已经被美国数以百万计的病人使用。"欣流"于1998年首次通过审议。同阿斯利康公司的"安可来"和紧急治疗公司的"奇摩"一样,是一种治疗哮喘和过敏的一流药物。

Merck officials stressed that the FDA's inquiry is based on reports, not clinical studies -- which are the standard tool for evaluating drug safety. The company said none of the 11,000 patients enrolled in 40 Singulair trials has committed suicide.
默沙东公司经理强调,FDA的调查只是基于一些报道,并没有临床研究做基础。而这也正是评估药品安全的标准。该公司表示,参与了40次"欣流"检验的一万一千名病人没有一人自杀。

“We have no indication that anything about the mechanism of Singulair is consistent with these events,'' said George Philip, director of research and product development. ''But because suicide is a life-threatening event we thought it was important to provide this information in the product label.''

“Patients should not stop taking Singulair before talking to their doctor,'' FDA said in its statement, adding that doctors should monitor patients for suicidal behavior and mood changes.
"病人不应该在未与医生商量的情况下自行停用"欣流"",FDA在此次陈述中指出,医生应密切观察病人以防他们情绪波动和自杀行为的出现。

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