1980～2001年FDA公布从美国市场撤消的药品

FDA Publication of Drugs Canceled from USA Market in 1980～2001

目的 :回顾 1980～ 2 0 0 1年美国FDA公告从市场上撤消的 2 0种处方药物。方法 :检索文献和FDA网站 ,从中获得信息资料 ,报道撤出的原因和时间。结果 :新药上市前由于临床研究的局限性 ,观察病例样本较少 ,因此一些罕见的不良反应通常发生率在 0 .0 1%以下 ,不易在较小样本的人群中和较短时间内出现 ,需要大量人群和长时间的应用后才被发现。结论 :①临床医师和药师应加强对药品不良反应的认识 ;②建立上市后药品的再评价 ,特别是对新药应进行大样本和多中心的临床观察 ,验证药物的安全性和有效性 ;③做到合理用药 。

Objective: To review the cancled 20 prescription drugs from market, published by FDA USA in 1980-2001. Method: The data, which reported the canceled reason and time, were obtained from the explored literature and FDA website. Result: The occurranee rate of some rare ADRs was usually less than 0.01% because of the limitation of clinical study and observed fewer cases samples before new drugs being gone on the market, the occurrance of ADRs was not easy in a fewer population and shorter time. Conclusion: 1) Clinical doctor and phamacists should enhance the recognition to ADR; 2) It must establish the re-evaluation after going on market, especially, the clinical observation of large samples, multiple centers should be conducted, the safety and effectiveness of drugs should be identified also. 3) Drug should be used rational, and don't abuse new drugs.