Generic antiarrhythmics are not therapeutically equivalent for the treatment of tachyarrhythmias
Generic antiarrhythmics are not therapeutically equivalent for the treatment of tachyarrhythmias
复制标题
DOI：
10.1016/s0002-9149(00)00715-3
复制
发表时间：
2000-05-01
影响因子：
2.8
通讯作者：
Kowey, PR
中科院分区：
文献类型：
--
作者：
Reiffel, JA;Kowey, PR
通过对130名心律失常专家的调查，评价了抗心律失常药物替代的后果。报告了54例心律失常复发、7例促心律失常事件和3例因仿制药替代导致的死亡，从而引起了对抗心律失常药物替代和仿制药批准程序充分性的严重关切。
The consequences of antiarrhythmic drug formulation substitution were assessed by survey of 130 experts on arrhythmias. Fifty-four arrhythmia recurrences, 7 proarrhythmic events, and 3 deaths resulting from generic substitution are reported, thus raising serious concerns about both antiarrhythmic drug substitution and the adequacy of the generic drug approval process.