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2007年5月,《新英格兰医学杂志》网站刊登研究报告说文迪雅可能大幅增加心脏病风险,导致死亡率增加的事实引起世界关注。欧盟药品管理局(EMEA)发布信息,建议暂停文迪雅及其复方制剂的上市许可。美国FDA决定严格限制文迪雅的使用,仅用于那些其他药品不能控制血糖的2型糖尿病患者。SFDA密切关注EMEA和FDA对罗格列酮及其复方制剂采取的新的监管措施,其措施反应了维护药物安全性的科学监管与保护公众利益的一致性。针对药物监管部门的这些决定,可以说是标志着糖尿病治疗的一个新时代的开始,以控制血糖水平的标准批准这类糖尿病治疗药物上市的时代已经结束。
In May 2007, a study published in the New England Journal of Medicine found that the fact that Wendia may significantly increase the risk of heart disease and cause an increase in mortality has caused worldwide concern. The European Medicines Agency (EMEA) released a message recommending a moratorium on the listing of Avandia and its companion preparations. The U.S. FDA has decided to severely limit Avandia’s use only for those with type 2 diabetes who do not control their blood sugar with other drugs. SFDA is closely monitoring the new regulatory measures taken by EMEA and FDA for rosiglitazone and its combination, reflecting the consistency between scientific regulation of drug safety and the protection of the public interest. These decisions for drug regulators can be said to mark the beginning of a new era in the treatment of diabetes and the time has come to pass the approval of a standard for controlling blood glucose levels for the listing of such diabetes therapies.