Postmarketing surveillance of ranitidine Pre-launch data in 3654 patients suggested that ranitidine was a well tolerated agent. Since then it has been the subject of many drug surveillance studies, 2 of which are briefly reviewed. The Prescription-Event Monitoring study analysed data from approximately 9600 general practice patients in England receiving ranitidine. The authors concluded that ranitidine was a very well tolerated and efficacious drug. The more recent Italian H 2 -Receptor Antagonist Study evaluated similar information on 28,216 patients from April 1986 to May 1987. In this study, 92% of prescriptions were for ranitidine, 4% for famotidine and 2.6% for cimetidine, with corresponding adverse effect incidence rates of 0.9%, 2.4% and 1.8%, respectively. However, direct comparisons are not possible because of the marked difference in the numbers of patients treated with each drug. Psychiatric and CNS symptoms were generally the most frequent adverse effects with ranitidine, although the overall incidence was still very low (about 0.2%). Headache, often recurrent, was the most common individual symptom. The incidence of adverse reactions to ranitidine and placebo did not differ significantly. Thus, postmarketing surveillance ' ... shows ranltldlne to have an excellent safety profile and considering Its outstanding efficacy, a rlskfbeneflt ratio among the most favourable In modern drug treatment'. Eandi M, De Carli GF, Buraglio M, Recchia G. Clinical Trials Journal 25: 152-157. No 2, 1988 .. ,. 4 REACTIONS'"' 25 June 1988 0157-7271 j88j0625-0004j0$01.00/0 © ADIS Press

Postmarketing surveillance of ranitidine

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Postmarketing surveillance of ranitidine

Pre-launch data in 3654 patients suggested that ranitidine was a well tolerated agent. Since then it has been the subject of many drug surveillance studies, 2 of which are briefly reviewed.

The Prescription-Event Monitoring study analysed data from approximately 9600 general practice patients in England receiving ranitidine. The authors concluded that ranitidine was a very well tolerated and efficacious drug. The more recent Italian H2-Receptor Antagonist Study evaluated similar information on 28,216 patients from April 1986 to May 1987. In this study, 92% of prescriptions were for ranitidine, 4% for famotidine and 2.6% for cimetidine, with corresponding adverse effect incidence rates of 0.9%, 2.4% and 1.8%, respectively. However, direct comparisons are not possible because of the marked difference in the numbers of patients treated with each drug.

Psychiatric and CNS symptoms were generally the most frequent adverse effects with ranitidine, although the overall incidence was still very low (about 0.2%). Headache, often recurrent, was the most common individual symptom. The incidence of adverse reactions to ranitidine and placebo did not differ significantly.

Thus, postmarketing surveillance ' ... shows ranltldlne to have an excellent safety profile and considering Its outstanding efficacy, a rlskfbeneflt ratio among the most favourable In modern drug treatment'.

Eandi M, De Carli GF, Buraglio M, Recchia G. Clinical Trials Journal 25: 152-157. No 2, 1988 .. ,.

4 REACTIONS'"' 25 June 1988 0157-7271 j88j0625-0004j0$01.00/0 © ADIS Press