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Cimetidine postmarket outpatient surveillance program. Interim report on phase I
JAMA
|April 18, 1980
Summary
Postmarket surveillance of cimetidine in 9,907 outpatients found a 4.4% adverse effect incidence, consistent with premarketing data. This study confirmed cimetidine
Area of Science:
- Pharmacovigilance
- Clinical Pharmacology
- Drug Safety
Background:
- Cimetidine is a widely prescribed medication.
- Postmarketing surveillance is crucial for assessing drug safety in real-world settings.
- Understanding the safety profile of cimetidine in a large outpatient population is important.
Purpose of the Study:
- To evaluate the safety and tolerability of cimetidine in a large cohort of outpatients.
- To assess the incidence and types of adverse effects associated with cimetidine use in routine clinical practice.
- To validate the findings from premarketing studies in a postmarketing setting.
Main Methods:
- A postmarket surveillance program was implemented for outpatients receiving cimetidine.
- Data were collected over a three-month period from 9,907 patients.
- Physician response rates and data collection methods were assessed.
Main Results:
- The overall incidence of reported adverse effects was 4.4%.
- The types of adverse effects observed were similar to those reported in premarketing controlled studies.
- Physician response to the surveillance program was high at 85.1%.
Conclusions:
- The postmarket surveillance program successfully gathered data on a large number of patients using cimetidine in routine practice.
- The safety profile of cimetidine was confirmed in this outpatient population.
- A follow-up phase will provide longer-term safety data.
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