FDA关于抑肽酶不良事件监管实录

FDA Memorandum about Monitoring and Management for the Aprotinin Adverse Drug Event

抑肽酶在美国批准上市时是用于心脏体外循环手术中预防失血过多的药物,上市以来对抑肽酶的安全性问题主要关注的是其可引起严重的过敏反应。2006年初,Mangano和Karkouti等质疑抑肽酶增加肾脏损伤或(和)心血管及脑卒中风险的文章发表后,美国食品药品监督管理局(FDA)提出了相应看法和应对措施。随着近两年来关于抑肽酶安全性问题信息的不断增加,FDA也在不断调整处理措施。通过对此过程的回顾,完整记录了FDA关于抑肽酶不良事件的一系列监管举措。

Aprotinin approved by FDA for prophylactic is used to reduce perioperative blood loss in the course of coronary artery bypass graft （CABG） surgery. It has been acknowledged that the major safety issues for aprotinin was a risk of anaphylaxis. By reviewing how FDA handled the new findings for the risk of the medicine after two research studies published separately by Mangano and Karkouti in 2006, which indicated that an increase in the chance of kidney failure or （and） heart attack and stroke in patients using aprotinin, recommended the continuing adjustment of risk management by FDA along with an increase in the safety information of aprotinin.