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【medical-news】FDA：房颤药tedisamil可致死
BELTSVILLE, Maryland (Reuters) - An experimental Solvay SA drug for a potentially fatal heart ailment could lead to deaths if used broadly in the population, a U.S. medical reviewer will argue on Wednesday.
The assessment comes as a U.S. Food and Drug Administration advisory panel mulls whether to recommend approval of the intravenous drug for atrial fibrillation (AF).
The committee will vote later this afternoon on whether to advise approval of the drug, known generically as tedisamil.
In AF, the heart's upper chambers do not pump effectively, putting patients at risk for blood clots and strokes. About 2.2 million Americans suffer from the condition.
"With widespread use if approved: There will be deaths from ventricular arrhythmias (abnormal heartbeat rhythm); there will be deaths from bradycardia (slow heart beat) and hypotension (low blood pressure)," Thomas Marciniak, FDA's medical team leader for the cardiovascular and renal unit, said in a document prepared for the advisory panel meeting.
"What will happen to safety in real-world use, particularly considering the complex dosing?" he wrote.
FDA staff reviews a company's application ahead of agency advisory meetings. An expert panel then makes a recommendation. Typically, the FDA follows those recommendations.
A Solvay official presented a plan to control risks of the drug if it is approved, by monitoring patients and employing a data safety board to continually assess benefits and risks.
The plan "should effectively mitigate the concerns related to the use" of the drug by "pro-actively addressing the known risks," said Earl Sands, the Belgian company's chief medical officer for U.S. research.
http://www.reuters.com/article/healthNews/idUSN1261210920071212 认领了，难得一下发这么多的药学新闻，先抢一篇，下午就交卷！ FDA：房颤药替地沙米（tedisamil）可致死
Wide Solvay heart drug use poses danger: FDA staff
FDA表示：广泛使用Solvay 公司的心脏病药物会带来危险
BELTSVILLE, Maryland (Reuters) - An experimental Solvay SA drug for a potentially fatal heart ailment could lead to deaths if used broadly in the population, a U.S. medical reviewer will argue on Wednesday.
贝兹维尔，马里兰州（路透社讯）—— 如果Solvay公司用于治疗潜在致命心脏疾病的实验性药物广泛使用，有可能会造成死亡，一位美国医药评论家将在周三对于此问题进行论述。
The assessment comes as a U.S. Food and Drug Administration advisory panel mulls whether to recommend approval of the intravenous drug for atrial fibrillation (AF).
这一评估来源于一个美国食品与药品监督管理局的顾问团提出，对于治疗心房颤动的注射药物是否批准需要进行慎重考虑。
The committee will vote later this afternoon on whether to advise approval of the drug, known generically as tedisamil.
顾问团将会在今天下午晚些时候，就是否建议批准替地沙米（tedisamil）进行投票。
In AF, the heart's upper chambers do not pump effectively, putting patients at risk for blood clots and strokes. About 2.2 million Americans suffer from the condition.
对于心房颤动的患者，心脏的上心房不能有效的抽吸血液，这样会造成患者血栓及中风的危险性增高。大约220万美国人患有这种疾病。
"With widespread use if approved: There will be deaths from ventricular arrhythmias (abnormal heartbeat rhythm); there will be deaths from bradycardia (slow heart beat) and hypotension (low blood pressure)," Thomas Marciniak, FDA's medical team leader for the cardiovascular and renal unit, said in a document prepared for the advisory panel meeting.
在一份用于顾问团会议的资料中，FDA的心血管及肾药物小组的领导者Thomas Marciniak 提出，如果批准广泛使用此种药物，将会出现死于室性心律失常的病例（心跳节奏异常），将会出现死于心动过缓（心脏跳动缓慢）及低血压（血压低）的病例。
"What will happen to safety in real-world use, particularly considering the complex dosing?" he wrote.
他写道，在现实生活中的使用安全性又将如何呢，尤其是考虑到复杂的剂量。
FDA staff reviews a company's application ahead of agency advisory meetings. An expert panel then makes a recommendation. Typically, the FDA follows those recommendations.
FDA的工作人员在顾问会议召开前，查看了一份这家公司的申请资料。一个专家小组随后提出了建议，FDA接受了这些建议。
A Solvay official presented a plan to control risks of the drug if it is approved, by monitoring patients and employing a data safety board to continually assess benefits and risks.
一位Solvay 公司的职员提出了一项计划来控制用药风险，如果这种药物被批准，公司将会采取一些措施，包括患者进行监护以及成立一个数据安全性部门来持续的评估使用此种药物的好处及风险。
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作者:admin@医学,生命科学 2011-08-14 17:15
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