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In an in vivo interaction study involving coadministration of fluoxetine with single doses of terfenadinea CYP3A4 substrateno increase in plasma terfenadine concentrations occurred with concomitant fluoxetine.
Fluoxetine has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart diseasePatients with these diagnoses were systematically excluded from clinical studies during the product’s premarket testingHoweverthe electrocardiograms of 312 patients who received fluoxetine in double-blind trialsfor a condition other than PMDDwere retrospectively evaluatedno conduction abnormalities that resulted in heart block were observedThe mean heart rate was reduced by approximately 3 beats/min.
Because clinical trials are conducted under widely varying conditionsadverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice.
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