论文部分内容阅读
去年9月,食欲抑制药芬氟拉明和右芬氟拉明从市场上撤销了。这是FDA对超声心动描记术研究进行评估后作出的决定。该项研究显示,受试患者31％具有心瓣膜异常。虽然FDA在收到瓣膜异常报道后即采取了行动,然而在24年前芬氟拉明即已被批准上市了。1997年12月,广泛使用的非镇静性抗组胺药特非那定也被撤销,因为市场上有了无特非那定那样具潜在致死性心律失常的替代药,然而特非那定已上市了12年。
In September last year, the appetite suppressants fenfluramine and dexfenfluramine were withdrawn from the market. This is the FDA’s decision after evaluating the echocardiographic study. The study showed that 31% of the patients tested had heart valve abnormalities. Although the FDA took action after receiving an abnormal report on the valve, 24 hours ago, Fenfluramine was approved for marketing. In December 1997, the widely used non-sedating antihistamine drug, terfenadine, was also withdrawn because there was an alternative drug with potentially fatal arrhythmia that was not as terfenadine on the market. However, terfenadine was already available. Listed for 12 years.