Andersen M, Schou J S
Sundhedsstyrelsens Bivirkningsnaevn, København.
Ugeskr Laeger. 1991 May 13;153(20):1410-3.
During the period from the first marketing of cimetidine in 1977 and until 31 March 1990, the Danish Committee on Adverse Drug Reactions received 494 reports concerning a total of 612 suspected adverse reactions to peptic ulcer drugs (ATC group A02B). Out of these, adverse reactions to H2-receptor antagonists constituted 90%. The investigation confirms the fact that safe drugs are concerned which only rarely cause serious adverse reactions. During the first year after cimetidine, ranitidine and sucralfate became available over-the-counter (27 March 1989-31 March 1990), only one report about side effects caused by cimetidine sold over-the-counter was received. This corresponds to what might be anticipated from the usage figures, if availability over-the-counter does not result in particular adverse reaction problems. Decrease in the number of reports, alterations in the pattern of adverse reactions and under-reporting of known adverse reactions render employment of data from voluntary reports difficult.
在1977年西咪替丁首次上市至1990年3月31日期间，丹麦药品不良反应委员会共收到494份报告，涉及对消化性溃疡药物（ATC分类A02B组）总计612起疑似不良反应。其中，对H2受体拮抗剂的不良反应占90%。该调查证实了这样一个事实，即所涉药物安全性良好，极少引发严重不良反应。在西咪替丁、雷尼替丁和硫糖铝非处方药上市后的第一年（1989年3月27日至1990年3月31日），仅收到一份关于非处方销售的西咪替丁所致副作用的报告。如果非处方药的使用不会引发特殊的不良反应问题，那么这与根据使用数据所预期的情况相符。报告数量的减少、不良反应模式的改变以及已知不良反应的漏报，使得利用自愿报告的数据变得困难。
