DRUG SAFETY DISCONTINUATIONS IN THE UNITED-KINGDOM, THE UNITED-STATES, AND SPAIN FROM 1974 THROUGH 1993 - A REGULATORY PERSPECTIVE
DRUG SAFETY DISCONTINUATIONS IN THE UNITED-KINGDOM, THE UNITED-STATES, AND SPAIN FROM 1974 THROUGH 1993 - A REGULATORY PERSPECTIVE
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DOI：
10.1016/0009-9236(95)90078-0
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发表时间：
1995-07-01
影响因子：
6.7
通讯作者：
LASAGNA, L
中科院分区：
文献类型：
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作者：
BAKKE, OM;MANOCCHIA, M;LASAGNA, L
本研究的目的是比较1974年至1993年期间在英国、美国和西班牙批准上市的新化学实体（NCE）和新生物制品实体（NBE）的数量，这些实体随后被停止（从市场上移除，撤回，或其许可证被允许失效），而存在安全问题，在研究期间的二十年中批准的产品中，共有29种药物随后在三个国家中的至少一个国家因安全原因而停用（英国：20例安全性停药;美国：10例;西班牙：这些药物占这些国家引进的所有药物的3%至4%，与1964年至1983年期间相比有所增加，当大约2%的ah NCE因安全性原因而停药时，最常与安全性停药相关的治疗类别是非甾体抗炎药（9种药物），血管扩张剂（四种药物）和抗抑郁药（三种药物），美国公司或其外国子公司作为发起人参与其中（专利持有人和/或开发商）约40%的药物因安全原因而停产。
The objective of the present study was to compare the number of new chemical entities (NCEs) and new biologicals entities (NBEs) approved for marketing during the period 1974 through 1993 in the United Kingdom, the United States, and Spain that were subsequently discontinued (removed from the market, withdrawn, or whose license was allowed to lapse) while a question of safety existed, Of the products approved during the two decades of the study period, a total of 29 drugs were subsequently discontinued for safety reasons in at least one of the three countries (United Kingdom: 20 safety discontinuations; United States: 10; and Spain: 16), These represent 3% to 4% of all drugs introduced in these countries, an increase compared to the period from 1964 through 1983, when approximately 2% of ah NCEs were discontinued for safety reasons, The therapeutic classes most commonly associated with safety discontinuations were the nonsteroidal anti-inflammatory drugs (nine drugs), vasodilators (four drugs), and antidepressants (three drugs), U.S. companies or their foreign subsidiaries were involved as originators (patent-holders and/or developers) of approximately 40% of the drugs discontinued for safety reasons.