[Adverse effects of ulcer drugs before and after release of cimetidine, ranitidine and sucralfate for over-the-counter sale]

Abstract

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.