FDA检查到顺尔宁科导致自杀倾向

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FDA Checks Into Singulair Suicide Risk
Possible Link Between Singulair Use and Suicide Risk Isn't Certain; Investigation May Take 9 Months

关于顺尔宁的使用和自杀倾向可能存在的联系是不确定的;调查工作可能需时九个月.

March 27, 2008 -- The FDA today announced that it is working with the drug company Merck to investigate a possible link between Merck's asthma and allergy drug Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior), and suicide.

2008年3月27日-FDA宣布他们正与默克制药公司着手调查默克公司的哮喘与过敏症药物顺尔宁与行为/情绪变化,企图自杀(自杀想法和举动）及自杀性行为可能存在的联系.

The FDA's investigation may take nine months. As of now, there's no proof that Singulair directly affects suicide risk.

FDA的调查工作可能需时九个月.截至目前.没有任何证据证明,顺尔宁能直接影响到自杀倾向

Meanwhile, the FDA calls Singulair \"effective\" and advises patients with questions not to stop taking Singulair before talking to their doctor.

与此同时，FDA呼吁顺尔宁是\"有效\"的,并劝告有病的患者在未与自己的医生交流之前不要停止服用顺尔宁.

The FDA also asks health care professionals and caregivers to monitor patients taking Singulair for suicidality and changes in behavior and mood.

FDA还要求专业医护人员和看护者监视服用顺尔宁的患者的企图自杀和行为与情绪的变化。

Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma. It's in a class of drugs called leukotriene receptor antagonists.

顺尔宁被用于治疗哮喘和过敏性鼻炎（打喷嚏,鼻塞,流鼻涕,发痒的鼻子）症状,并预防运动诱发性哮喘.它的一类被称做白三烯受体拮抗剂的药物.

Other leukotriene modifying medications include the asthma drugs Accolate, Zyflo, and Zyflo CR. The FDA is reviewing postmarketing reports it has received of behavior/mood changes, suicidality, and suicide in patients who took Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.

其他的白三烯修饰类药品包括Accolate, Zyflo, and Zyflo CR哮喘药。FDA正在复审上市后已收到的报告,内容是关于曾服用过Accolate, Zyflo和Zyflo CR的患者的行为/情绪变化,企图自杀,自杀性行为的,并决定是否需要进一步调查.

Singulair Time Line
顺尔宁时间索引

The FDA notes that over the past year, Merck has updated Singulair's prescribing information and patient information to include the following postmarketing adverse events: tremor (March 2007), depression (April 2007), suicidality (October 2007), and anxiousness (February 2008).

FDA指出,在过去的一年中，默克公司已经更新了顺尔宁的处方信息及病人资料，包括下列上市后的不良事件：颤动（ 2007年3月）,抑郁症（ 2007年4月）,企图自杀（ 2007年10月） ,焦虑（ 2008年2月）

In February 2008, the FDA and Merck discussed how best to communicate these labeling changes to prescribers and patients. According to the FDA, Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescribers and to provide prescribers patient information leaflets about Singulair.

在2008年2月，FDA和默克讨论如何更好地对这些类别的开方人与病人的变化进行沟通.通过FDA，默克公司计划与开方人进行面对面的交流,使近期在处方信息的改变更显著,并提供开方人/患者关于顺尔宁的信息资料.

In response to inquiries received by the FDA, the FDA has asked Merck to evaluate Singulair study data for more information about suicidality and suicide. The FDA is also reviewing its postmarketing reports of behavior/mood changes, suicidality, and suicide in patients who took Singulair.

在回应调查所得,FDA已要求默克公司对顺尔宁关于企图自杀和自杀性行为的研究数据进行评估.FDA也正在重审服用顺尔宁的病人关于行为/情绪变化,企图自杀,自杀性行为的上市后的报告.

Singulair's web site includes the most current prescribing information and patient information for Singulair, according to the FDA.

据FDA所说,顺尔宁的网站上包含了有关顺尔宁最新的处方信息以及病人资料.