华盛顿(路透社)消息――美国健康办公室于周五宣布,拜耳AG的心脏外科用药Trasylol有增加肾脏损害的危险,未来应用中应提高警惕。
食品与药品管理局也称此药物可能导致致死性变态反应或过敏反应。在近几年使用过此药的患者不应再接受Trasylol治疗。
同时,也应该限制那些有出血风险的患者和进行冠状动脉旁路移植术的患者使用Trasylo。
拜耳说,对那些已经出现或可能出现肾脏问题的患者使用Trasylo时,医生应该考虑其“利与弊”。此说明使拜耳股票下降了62个百分点或大于1%,在纽约证券交易所降到52.79美元。
自年初发表的两项研究将药物使用与肾脏问题联系在一起后,Trasylo就成为了FDA 安全检查的核心。此药物作为牛抑肽酶于1993年批准上市。Trasylol旨在减少出血,并满足心脏手术患者的输血需要。
Bayer drug can cause kidney damage, FDA warns
Fri Dec 15, 2006 5:00pm ET
By Susan Heavey
WASHINGTON (Reuters) - Bayer AG's heart-surgery drug Trasylol can increase the risk of kidney damage, U.S. health officials warned on Friday, adding that more precautions may be needed in the future.
The Food and Drug Administration also said the drug will come with a stronger warning about possibly fatal allergic reactions, or anaphylaxis. Patients should not receive Trasylol if they have already been given the drug within the past year, it said.
Use of Trasylol should also be limited to certain patients at an increased risk of blood loss and transfusions during coronary bypass graft surgery, the agency added.
Doctors should consider the "balance of benefits and risks" before giving Trasylol to patients who already have kidney problems or those at risk of them, Bayer said in a statement.
The warning sent Bayer shares down 62 cents, or more than 1 percent, to $52.79 on the New York Stock Exchange.
Trasylol has been at the center of an FDA safety review since two published studies linked the drug's use to kidney problems earlier this year.
The drug, approved in 1993, is also known as aprotinin bovine. It aims to reduce bleeding and the need for blood transfusions in heart surgery patients.
http://today.reuters.com/news/articlenews.aspx?type=healthNews&storyID=2006-12-15T220005Z_01_N15373991_RTRUKOC_0_US-BAYER-TRASYLOL.xml&WTmodLoc=HealthNewsHome_C2_healthNews-7
编辑:蓝色幻想
作者: feierdk 译
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