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Is cimetidine associated with neutropenia?
B L Strom1, J L Carson, R Schinnar
1Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia 19104-6021, USA.
The American Journal of Medicine
|September 1, 1995
Summary
Cimetidine is considered safe for over-the-counter use, as this study found no significant link between cimetidine and neutropenia. The risk of drug-induced neutropenia is extremely low, supporting its safety profile.
Area of Science:
- Pharmacovigilance
- Drug Safety Evaluation
- Hematology
Background:
- Cimetidine is being considered for over-the-counter (OTC) availability.
- Residual concerns exist regarding cimetidine-induced neutropenia.
- This study aimed to evaluate the association between cimetidine use and neutropenia.
Purpose of the Study:
- To assess the risk of neutropenia associated with cimetidine use.
- To determine if cimetidine poses a significant safety concern for OTC availability.
Main Methods:
- Population-based, case-control study utilizing Medicaid data from six states.
- Cases were patients hospitalized with neutropenia; controls were matched by age, sex, state, and diagnosis year.
- Cimetidine exposure in the 30 days prior to hospitalization was compared between cases and controls.
Main Results:
- Conditional logistic regression controlling for confounding variables showed an odds ratio of 1.2 (P=0.33) for cimetidine use and neutropenia.
- No dose-response relationship was observed.
- The risk of hospitalization with neutropenia or agranulocytosis due to cimetidine was calculated to be very low.
Conclusions:
- Any association between cimetidine and neutropenia appears to be very small.
- The findings support the safety of cimetidine for potential OTC use.
- The study provides evidence to alleviate concerns about cimetidine-induced neutropenia.