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【drug-news】FDA发表了Chantix（一种戒烟药物）的早
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01749.html
FDA Issues Early Communication for Chantix
Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Chantix, a drug approved as an aid to smoking cessation treatment. An Early Communication reflects FDA’s current analysis of available data concerning these drugs and does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue.
FDA is evaluating postmarketing adverse event reports for Chantix (varenicline), a prescription medicine to help adults stop smoking.
Based on FDA’s request for information from the manufacturer, Pfizer, Inc., the company recently submitted reports to the agency describing suicidal ideation (thoughts). In the wake of a case report citing erratic behavior in an individual who had used Chantix, FDA has also asked the company for any information on additional cases that may be similar in patients who have taken the drug.
FDA’s Center for Drug Evaluation and Research is working to complete an analysis of the available information and data. When this analysis is completed, FDA will communicate the conclusions and recommendations to the public.
In the meantime, FDA recommends that health care providers monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
FDA also advises that, due to reports of drowsiness, patients should use caution when driving or operating machinery until they know how using Chantix may affect them.
Full text of the Early Communication about the Ongoing Safety Review can be found at: http://www.fda.gov/cder/drug/early_comm/varenicline.htm. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 FDA Issues Early Communication for Chantix
FDA发表了戒烟药物Chantix的早期报告
Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Chantix, a drug approved as an aid to smoking cessation treatment. An Early Communication reflects FDA’s current analysis of available data concerning these drugs and does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue.
背景介绍：美国食品及药品管理局（FDA）就目前还在进行中的Chantix药物安全性评价发表了一份早期报告。Chantix是一种已经批准上市的辅助戒烟的治疗药物。这份关于Chantix药物安全性的早期报告仅仅反映了FDA对该药物已有数据的分析结果，并不表示FDA已经作出结论认为该药物与目前不断出现的安全性问题具有因果关系。
FDA is evaluating postmarketing adverse event reports for Chantix (varenicline), a prescription medicine to help adults stop smoking.
FDA正在评价一种帮助成人戒烟的药物Chantix（商品名varenicline）上市后的一些不良反应报告。
Based on FDA’s request for information from the manufacturer, Pfizer, Inc., the company recently submitted reports to the agency describing suicidal ideation (thoughts). In the wake of a case report citing erratic behavior in an individual who had used Chantix, FDA has also asked the company for any information on additional cases that may be similar in patients who have taken the drug.
按照FDA表示要提供进一步信息的要求，Chantix的制造商辉瑞制药公司最近向FDA提交了几份报告，详细描述了自杀行为（思维）的形成过程。此前，在关于一位使用Chantix药物的患者产生古怪行为的一份病例报告公开以后，FDA也同样要求辉瑞制药公司调查其他服用Chantix药物的病人是否曾有类似的不良反应。
FDA’s Center for Drug Evaluation and Research is working to complete an analysis of the available information and data. When this analysis is completed, FDA will communicate the conclusions and recommendations to the public.
FDA药物评价和研究中心正在就Chantix不良反应事件编写一份现有信息和数据的分析报告。报告完成后FDA将向公众公开分析结果，并给出倾向性的意见。
In the meantime, FDA recommends that health care providers monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
在此同时，FDA建议健康和医疗服务机构注意观察服用Chantix药物的病人行为和情绪的变化。服用Chantix药物的病人如果经历过行为或情绪方面的变化应主动联系自己的医生。
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作者:admin@医学,生命科学 2011-06-28 18:00
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