Miwa L J, Jolson H M
Epidemiology Branch, Food and Drug Administration, Rockville, Maryland 20857.
Pacing Clin Electrophysiol. 1992 Apr;15(4 Pt 1):387-90. doi: 10.1111/j.1540-8159.1992.tb05133.x.
Propafenone hydrochloride was approved for marketing by the United States (U.S.) Food and Drug Administration (FDA) in November 1989. During U.S. clinical trials of propafenone, one case of agranulocytosis was seen. Seven additional cases have been reported outside the U.S. One German report of profound but reversible granulocytopenia appeared in 1982. In January 1991, the FDA reviewed adverse events reported with propafenone. Four reports of agranulocytosis were identified and are described. The reporting rate of approximately one case of agranulocytosis per 10,000 propafenone prescriptions per year likely underestimates the true incidence of this adverse event.
盐酸普罗帕酮于1989年11月获美国食品药品监督管理局（FDA）批准上市。在美国进行的普罗帕酮临床试验期间，出现了1例粒细胞缺乏症病例。在美国境外又报告了另外7例。1982年有1篇来自德国的报告称出现了严重但可逆的粒细胞减少症。1991年1月，FDA审查了与普罗帕酮相关的不良事件报告。确定并描述了4例粒细胞缺乏症报告。每年每10000张普罗帕酮处方中约有1例粒细胞缺乏症的报告率可能低估了这一不良事件的真实发生率。
